Rare complications of vascular access devices

Rare complications of vascular access devices

Rare C o m p l i c a t i o n s of Vascular Access Devices Rebecca J. Ingle Objective: To provide an overview of rare complications ~ c u l a r access...

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Rare C o m p l i c a t i o n s of Vascular Access Devices Rebecca J. Ingle

Objective: To provide an overview of rare complications ~ c u l a r access devices in terms of etiology, assessment, management, and follow-up. Conclusions: Rare complications of vascular access devices are serious and in some cases life-threatening. These complications include pinch-off and catheter fracture, catheter malposition and migration, cardiac perforation, extravasation, breakage, and defective devices. Knowledge and awareness of these complications can contribute to accurate identification and immediate management. Documentation and reporting of complications to the Food and Drug Administration helps to ensure the safety and efficacy of vascular access devices.

Implicationsfor nursing practice: Developing the expertise needed to manage these types of complications is a continual challenge to the oncology nurse. Although managing rare complications is usually performed by a physician, recognizing the clinical manifestations will alert the nurse to seek medical advice immediatel2~, thus decreasing the risk of mortality. All health care professionals are responsible for continually monitoring vascular access devices, consistently documenting findings, and communicating recommendations for care.

ASCULAR ACCESS devices (VADs) have enhanced the quality of life for many persons with cancer. As these devices approach their third decade of use, it has become clear that they offer many advantages and options for patients receiving multiple intravenous (IV) therapies. However, years of use have also clearly defined the plethora of complications associated with VADs. Although infection and occlusion are the most common complications, other less-common complications may be just as serious and in some cases life-threatening. This article reviews rare complications of VADs, including catheter pinch-off and fracture, catheter malposition and migration, cardiac perforation, extravasation, VAD breakage, and defective VADs, followed by a discussion of the voluntary and mandatory components of the Food and Drug Administration's (FDA) reporting system for serious complications associated with VADs.

viously described and reported. 1-18 Although catheter pinch-off often precedes and may even predict the later occurrence of fracture, the causative mechanism is the same for both complications. 1-3,9 Catheter pinch-off, first described by Aitken and Minton,l can be defined as the anatomic, mechanical compression of a catheter as it passes between the clavicle and first rib at the costoclavicular space. 1-3,9 When the catheter is surgically placed using a percutaneous puncture medial to the midclavicular line, the catheter travels through the costoclavicular space next to the subclavian vein rather than inside it (Fig 1) and it is vulnerable to compression with shoulder movements. 1,3,7 The clinical manifestations of pinch-off include withdrawal occlusion, resistance to infusion of fluids, or a positional IV line, which requires awkward patient positioning to release the compression between the clavicle and first rib. 2 Catheter pinchoff may be seen on chest radiograph as the "pinchoff sign" (Fig 2), which presents as a visible luminal compromise of the catheter at the clavicle/ first rib area and is often a prognostic sign for later fracture. 1-3 Catheter fracture is defined as the complete or partial breakage of a VAD catheter internally with migration of the distal catheter fragment, usually to the right ventricle or the pulmonary artery. 1,7.9 The most commonly described cause is the same as that for pinch-off: a mechanical compression of the catheter as it passes through the costoclavicular space, with gradual trauma to the catheter resulting in breakage. 1'3'7 When removed, catheter fragments have been reported to have a permanent el-



VAD catheter pinch-off and fracture are two closely related complications that have been preFrom The Dan Rudy Cancer Center, Saint Thomas Hospital, Nashville, TN. Rebecca J. Ingle, MSN, RN, OCN: Oncology ClinicalNurse Specialist, The Dan Rudy Cancer Center, Saint Thomas Hospital. Address reprint requests to Rebecca J. Ingle, MSN, RN, OCN, The Dan Rudy Cancer Center, Saint Thomas Hospital, 4220 Harding Rd, Nashville, TN 37205. Copyright © 1995 by W.B. Saunders Company 0749-2081/95/1103 -000555.00/0 184

Copyright © 1995 by W.B. Saunders Company

Seminars in Ontology Nursing, Vol 11, No 3 (August), 1995: pp 184-193


Fig 1. A catheter inserted medial to the midclsvicular line travels alongside the subclavian vein through the pinch-off zone and is vulnerable to compression with shoulder movement. (Reprinted with permission,s}

liptical, "fish-mouth" compression, and under electron microscopy, rough jagged edges, indicating mechanical trauma rather than surgical shearing, are seen. 4'7'15'16 Adverse effects associated with fracture include cardiac arrhythmias, 4 an extra heart sound, 11 and potential extravasation of vesicant agents. The sequelae can include unanticipated invasive surgical procedures for catheter fragment and VAD removal, and potentially dangerous thrombus formation around the fragment. 19 Reports of death associated with long-term catheter fragment embolization are rare, but they have been reported. 2° In a comprehensive literature review of 22 catheter fractures, the incidence of fracture was almost equal in various brands of tunneled catheters and implantable ports. 2 The reported site of fracture was at the clavicle/first fib area in 82% of cases, and the mean time from insertion to fracture was 6.5 months, with a range of 3 weeks to 13 months. Some degree of catheter pinch-off was observed on chest radiograph in 12 of 27 patients, and in 7 of those 12, the pinch-off sign was noted on the immediate postinsertion chest radiograph. In 21 of 27 patients, the catheter fragment migrated to either the fight heart or pulmonary artery. Twenty-three fragments were successfully removed, whereas no attempt at removal was made in two patients, and the fragments could not be removed in two patients. Although the removal of catheter fragments is usually accomplished percutaneously without difficulty using an intravascular snare retrieval device, 2 there are reports of further breakage of the fragment into two or more pieces during retrieval


attempts. 18,21,22 In two patients, the smallest fragment embolized to a distal pulmonary artery branch and was not removable. 18,22 Nursing assessment for signs and symptoms of pinch-off and fracture is important in reducing the risk for morbidity. The two most common clinical symptoms of pinch-off include sudden and/or intermittent withdrawal occlusion and resistance to the infusion of fluids. Although other VAD complications may cause these symptoms, if patient position changes of the arms or shoulders are necessary to obtain a blood return or to facilitate IV flow, pinch-off syndrome is the likely complication. The most common symptoms associated with catheter fracture include chest wall swelling at the port pocket or vein insertion site and pain in the shoulder or port area unassociated with swelling. 2 Other reported symptoms include withdrawal occlusion, 7 resistance to injection of fluids, 4 sudden onset of chest pain o r c o u g h , 11'16'23 palpitations, 4 and a swishing sound with catheter irrigation. 4 Some patients are asymptomatic because of the

Fig 2. The pinch-off sign on chest radiograph. (Reprinted with permission, s)


presence o f few sensory nerve endings in the vascular endothelium and endocardium where catheter fragments lie. 14 The management of catheter pinch-off and fracture includes both preventive and early detection measures. When a VAD is surgically placed using a percutaneous approach, a puncture made lateral to the midclavicular line places the catheter inside, rather than alongside, the subclavian vein before it passes through the "pinch-off zone," thereby reducing the risk for unprotected catheter compression (Fig 3). 4'7'9'10'12 Future problems with pinchoff may be predicted during surgical placement when resistance is encountered during initial insertion at the clavicle/f'trst rib area. 2'8'9'17 If a lateral percutaneous approach is not possible, documentation should include the special considerations preventing it, and alternate vein sites should be considered. Prevention of fracture may also be accomplished by instructing patients with VADs to minimize heavy physical activity that uses the shoulder, because there are case reports of fracture occurring within weeks of playing golf, lifting weights, or playing basketball. 7'13'14 Early detection of pinch-off can be achieved by careful radiographic monitoring. Hinke et al 3 devised a grading scale for the degree of pinch-off or catheter distortion on chest radiograph at the costoclavicular area and gave recommendations for management based on the distortion grade (Table 1). Chest radiographs should be taken in the upright position with the arms down by the sides instead of the standard position with the shoulders rolled forward. 3 This "everyday" position allows for more sensitive detection of pinch-off, which may change with shoulder movement. The au-


thor's institution has implemented a VAD chest radiograph series specifically to detect and monitor pinch-off. This three-view series consists of the standard two-view anteroposterior (AP) and lateral chest radiograph, plus a third AP view with the patient's arms held down by the side. As noted in Table 1, any degree of distortion should be addressed with appropriate monitoring and follow-up. OTHER CAUSES OF CATHETER EMBOLISM

One commonly reported cause of embolism is separation of the catheter from the implantable port caused by slippage of the connecting O-ring or other locking device.ll"14'24-27 This separation may occur because of forceful flushing in the presence of distal obstructionE4; manufacturing defect, resterilization, and reuse of disposable VAD cathetersZS; and incorrect locking procedures used to attach the catheter to the port during insertion. In one case, the patient reported a popping sensation and stinging pain at the moment of catheter separation. 11 Catheter shear from needles, insertion site sutures, or surgical instruments during insertion may also result in embolism and is more commonly seen in peripherally inserted central catheters (PICCs) than in other WADs. 4'19'29 With PICC embolism, immediate localization of the fragment should be attempted by applying pressure to the site of breakage or by applying a tourniquet proximal to the site. 29 If a radiograph verifies fragment localization, a venous cutdown may be performed for removal. If migration of the fragment to the central circulation has occurred, percutaneous removal may be attempted, although a thoracotomy may be required when percutaneous attempts are unsuccessful. 29 CATHETER MALPOSlTION

Fig 3. Surgical insertion lateral to the midclavicular line places the catheter inside the subclavian vein before it passes through the pinch-off zone where it is less vulnerable to compression. (Reprinted with permission, s)

The Central Venous Catheter Working Group of the FDA has established that correct tip placement is at the superior vena cava/right atrial junction. 2 Catheter malposition may be primary, occurring at the time of insertion, or secondary, when a catheter tip spontaneously migrates to another venous location after initial placement. 3° Because the management of tunneled and implanted VADs is different from that of PICCs, each will be discussed separately.



Table 1. Radiographic Grading of Catheter Distortion at the Costoclavicular Area


O 1 2 3

CatheterDistortion on Chest Radiograph


No distortion Some degree of distortion without luminal narrowing Distortion with luminal narrowing Fracture


None Uncertain

None Close follow-up

Subsequent fracture likely Risk of catheter embolization

Remove catheter Remove catheter promptly

Based on information from Hinke et al.3 Reprinted with permission. 2

Malposition of Tunneled and Implanted VADs Correct catheter tip position is important in preventing complications, such as thrombosis, 31 perforation, 32 pericardial tamponade, 33 endothelial damage, 34 extravasation, 35 and fistula formation. 36 Usually catheters are inadvertently inserted into the larger tributaries of the superior vena cava (SVC), such as the jugular system, 17,37,38although there are case reports of cannulation of small SVC tributaries, including the internal mammary, 37'39 azygous, 36'38 superior intercostal, 37 and pericardiophrenic 39 veins (Fig 4). It has been suggested that malposition is more common via the left brachiocephalic vein than the right, because it is longer, more oblique, and has a larger number of small tributaries37; however, others believe that the left subclavian vein is the preferred insertion approach because of lower risk of malposition into the jugular system. 4° Inadvertent cannulation of the small venous tributaries has been associated with precordial chest pain, midthoracic back pain, and shoulder pain, each intensified by infusion of hypertonic solutions, such as total parenteral nutrition (TPN), and relieved by removal or repositioning of the cathe-


?'lnfedo "
Fig 4. Veins of the neck or mediastinum in which catheter malposition may occur.

ter. 39 Because of low blood flow in the venous tributaries, early postoperative thrombosis has occurred and has been implicated as a causative factor in the extravasation of vesicant chemotherapeutic agents because of backtracking. 39'41'42 Correct catheter position should be confirmed after surgery by obtaining both AP and lateral chest radiographs or fluoroscopic views, especially if TPN or chemotherapy are to be infused. Omission of the lateral view may result in failure to detect a malpositioned catheter. 36 Blood return is not a reliable indicator of malposition, because even catheters in small veins may allow free return of venous blood. 37'41 Malpositioned catheters may be repositioned using percutaneous vascular techniques. 39 Secondary catheter migration out of the SVC has occurred at intervals ranging from days to months after VAD implantation. 19,30,38,43-51 Most commonly, the migration is retrograde into the ipsilateral jugular vein, 19,30,44,46,47,49 although there are case reports of spontaneous withdrawal into the brachiocephalic, 43 subclavian, 44 azygous 46 and axillary 38 veins and into the subcutaneous tissue. 45,48

The mechanism for spontaneous migration is unclear. Proposed mechanisms have included vigorous upper extremity use3°; forceful flushing of the catheter; congestive heart failure; catheter foreshortening; or changes in intrathoracic pressure associated with coughing, emesis, or constipation. 3°'44'49 However, when Krasnow et a149 fluoroscopically evaluated the effects of forceful coughing, Valsalva's maneuver, and forceful flushing on catheter tip location, no tip movement was observed. "Twiddler's syndrome," characterized by the intentional or unintentional manipulation of subcutaneous ports or catheters, has been reported as a mechanism for complete catheter withdrawal from the vein. 5°'52 This syndrome may be an indication


of patients' anxiety about having the device inserted, and often patients are unaware of their manipulation of the devices. Nursing assessment for signs and symptoms associated with catheter migration is paramount in preventing further complications. Some patients are asymptomatic, although others may present with partial or complete catheter occlusion; chest, shoulder, or back pain with infusion37; decreased IV infusion rate; signs of extravasation; ipsilateral extremity edema; dyspnea; or odynophagia. 44 An "ear gurgling" sound may be described by patients with catheters malpositioned in the internal jugular vein. 37 An AP and lateral chest radiograph should be obtained for any patient experiencing signs or symptoms of malposition. Asymptomatic malposition into a large tributary, such as the internal jugular vein, may not necessitate removal or repositioning of the device as long as it is carefully monitored. Although sometimes malpositioned catheters spontaneously return to the correct position, 19 repositioning or removal is preferable, especially if hypertonic or sclerosing agents are to be infused 19'46 or if the patient reports pain. a/

Malposition of PICCs The incidence of malposition in PICCs has been reported to be between 21% and 55%. 32 In a review of 158 PICC insertions, cannulation in the right basilic vein had the highest incidence of malposition at 32%. 53 When PICCs are inserted via the basilic vein, they are most commonly misdirected into the internal jugular vein, whereas cephalic vein insertions most commonly are associated with axillary vein malposition. 32 PICC malposition and secondary migration have also been reported to occur in other central venous tributaries, including the subclavian, azygos, brachiocephalic, internal mammary, and pericardiophrenic veins 29'32 as well as into the right atrium and right ventricle. 29 PICC malposition may occur during insertion, at the time of guidewire exchange, or by later spontaneous migration. 32'54 Although softer Silastic and polyurethane materials have facilitated the ease of insertion of PICCs, these newer materials have also predisposed the catheters to greater frequency of looping, coiling, and knotting within the v e i n . 29,55

Signs and symptoms of PICC malposition may


include blood backflow into the extension tubing unrelated to increased intrathoracic pressure, 54 resistance or discomfort during PICC insertion, or bending in the guidewire when removed from the catheter. 29 Other signs and symptoms of VAD catheter malposition are discussed elsewhere in this article. Prevention of primary PICC malposition may be accomplished by externally measuring the approximate course of the vein to determine appropriate catheter length. 32'53 It has been reported that with the basilic vein insertion, extending the patient's arm at a 90 ° angle from the body with the head turned toward the insertion arm and chin down helps prevent entry of the PICC into the jugular vein. 29'53 However, Goodwin and Carlson 55 reported in their series that this patient positioning made no significant difference in preventing jugular malposition. Catheter tip position should be verified by chest radiograph. Various nursing interventions have been successful in managing malpositioned PICCs. Removing the guidewire, or partially withdrawing and then readvancing the catheter under sterile conditions, may be all that is necessary. 53 A catheter in the right atrium may be withdrawn several centimeters to correct the tip location. Patient position changes, including hyperextending or rotating the arm, applying traction to the wrist, or encouraging the patient to walk around and cough a few times, have resulted in s u c c e s s . 55'56 Placing the patient in a semi-Fowler's position may allow a catheter in the jugular system to fall into the correct position. A rapid flush with 10 to 20 mL of normal saline may help the catheter to flip into place, 32'53"54 although this technique is not successful with double-lumen PICCs or with rigid, inflexible PICC catheters. 32 More complicated malpositions that do not respond to the above measures may require repositioning using fluoroscopy, or catheter removal. 54'55 PERFORATION

VAD catheter perforation of the SVC or endocardium has been described in c a s e reports. 29'33'57"5~ SVC perforation has resulted in extravasation of infusate into the pericardium, 58 bronchus, or pleural space, 59 causing pleuritic chest pain, arrhythmias, hemoptysis, and severe respiratory distress. Proposed causes of soft catheter perforation of the


SVC have included guidewire puncture during insertion and catheter tip cut at a pointed taper, each in conjunction with local irritation by infused antimetabolite chemotherapy. 58'59 A radiographic warning sign of SVC perforation is a catheter tip that becomes more curved on chest radiograph over several days. 34 Cardiac perforation may occur during insertion or as a late complication, often because of catheter migration into the heart. Cardiac tamponade and death may result. 29'33'57 A universal finding at autopsy is thrombosis at an area of denuded endocardium at the catheter tip, with leakage of fluid into the pericardial space. 57 Perforation may be prevented by correct catheter tip placement and by removing or repositioning any catheter that exhibits a curved tip on chest radiograph. Any signs or symptoms of perforation, including those consistent with pericarditis or cardiac tamponade, should be immediately reported to the physician. 34 EXTRAVASATION

Extravasation, although more commonly seen as a complication of peripheral IVs, is also a potentially serious consequence of vesicant infusion through VADs. One patient required a simple mastectomy to manage chest wall necrosis. 6° Others have reported severe inflammation and necrosis of the skin and subcutaneous tissue that necessitated device removal, 51'6°-66 although some extravasations have been successfully managed locally with no further intervention. 5°'66-68 Signs and symptoms of VAD extravasation include swelling at the port pocket or vein insertion site48,61,66; severe pain and burning over the chest wa116°'65; swelling along the subcutaneous tunnel of the catheter65; and infraclavicular, neck, or shoulder pain. 6° Although other VAD complications may also cause pain, tenderness, and inflammation, extravasation should always be considered when a vesicant is administered. Three primary mechanisms have been established as the most common causes of VAD extravasation: needle dislodgement from implanted ports; damage, breakage, or separation of VAD catheters; and thrombus formation at the catheter tip. Needle dislodgement from the septum of implanted ports has been reported in both inpatient and outpatient settings. 19"26'27'51"61'62'64'66"67'69


Dislodgement may be related to inadequate needle stabilization, suboptimal location of the portal body, or slippage of the siliconized, noncoring needles used to access the port. Needles should be adequately secured within the port by taping the hub or wings of the needle to the chest before applying the dressing. Extension tubing should be of adequate length to allow for patient movement and should be taped to eliminate direct pulling against the needle. The needle site should be checked frequently, especially during vesicant chemotherapy infusion, because a dislodged needle can remain under the skin and appear to be correctly placed. Nonsiliconized needles should be used to reduce the risk of slippage. 41 The optimal site for port placement is in the infraclavicular fossa at midclavicle where it is over a firm surface and less mobile with shoulder movement. 34'41'51 Before surgery, the port location should be marked on women wearing brassieres and on obese patients in the upright position, because implantation under breast or deep adipose tissue makes access difficult and can increase the risk for extravasation. 34'41'5° Extravasation may also be caused by catheter fracture and catheter/portal separation as previously discussed. Other causes include surgical sheafing, pinholes, complete withdrawal of a catheter from the vein, and a damaged or dislodged portal septum, causing leakage of infusate subcutaneously. 20,48,70 Retrograde flow of infusate along a catheter encased in a fibrin sleeve, called backtracking, has been reported to cause extravasation. 8,19,3s'3s'6°'64 Thrombus formation at the catheter tip obstructs the free flow of infusate, causing flow back along the catheter into the subcutaneous tissue. Backtracking is believed to be more common when VADs are placed percutaneously, because there is no suture around the vein, as with a cutdown placement, to provide a barrier to backflow. 6° However, backtracking has been reported in patients who had catheters placed by the percutaneous and cutdown techniques. 8 Nursing assessment is critical in preventing extravasation. Before initiating an infusion, the VAD should be aspirated for blood return; absence of blood return should prompt further assessment to verify patency and correct placement of the catheter. The patient should be instructed to report any discomfort, pain, or stinging during an infusion,



and the exit site should be observed frequently for any sign of edema, erythema, or fluid leakage. Patients receiving home infusions by ambulatory infusion pumps should be educated about the signs and symptoms of extravasation and whom to call if extravasation is suspected. Published guidelines about VAD extravasation recommend adherence to principles of peripheral extravasation management. 71 VAD BREAKAGE AND DAMAGE

Breakage of VADs usually involves the catheter and may occur internally or externally. 29'63'72-75 The most commonly reported cause of breakage is catheter rupture caused by forceful flushing or use of a power injector during radiological procedures in the presence of intraluminal thrombosis. 28'54'55'76"77 Breakage or damage to the catheter may also occur during catheter removal, 21'72 as a result of tight sutures, 76 or as a result of surgical sheafing or puncture with a suture needle during insertion. 28 PICCs may shear during insertion if pulled back through a break-away needle. 29 Catheters that have been in place for a prolonged period may be more susceptible to breakage because of thinning or tears in the silicone, breakage at the catheter hub, or loss of threads on the catheter hub. 74'76 Damage to the portal septum will occur if needles other than noncoring are used to access the port. Leakage is the most common sign of VAD breakage or damage, although internal breakage may result in catheter embolism. 55'76 Other signs and symptoms include unexplained moisture or blood on a dressing or reflux of blood into the catheter or extension tubing. 54,75 Air embolism has been reported in patients with external catheter breakage. 73 To prevent VAD damage, forceful flushing should be avoided, and any resistance to flushing should be further evaluated. When evidence of external catheter damage is observed, the catheter should be clamped proximal to the damaged area and covered with sterile gauze until it can be repaired, exchanged, or removed. 42'54'55 Userfriendly repair kits are available from the manufacturer for most PICCs and tunneled catheters. Although repairs are usually effective, there are case reports of migration of the metal splice seg-

ment used in the repair of tunneled catheters to the catheter exit site. 74 DEFECTIVE VADs AND FDA REPORTING

As with any device or product, manufacturing defects sometimes occur in VADs and in VADrelated products. Types of reported defects have included dislodged portal septums or other septum defects, missing or defective O-ring connectors, bent or broken guidewires, defective sheath introducers, holes in the catheter, and catheters that fell apart before insertion. Incorrect labeling of products and improper fit of a catheter to the portal body have also been reported. 2° In accordance with the Safe Medical Devices Act of 1990, health care facilities and manufacturers are required by law to report any device-related event or malfunction that caused, or could potentially have caused, serious injury or death. Serious injury is defined as " a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permanent impairment or damage (p. 2768)."78 Reporting by health care professionals has always been voluntary, but it is a vital link in assuring that problems encountered are brought to the attention of manufacturers and the FDA. In response to voluntary reporting, the FDA has issued warnings, required postmarketing studies from manufacturers, made labeling changes, and issued recalls that have ultimately prevented patient suffering and death. 78 Because nurses are the principal VAD users, their reporting of VAD defects and complications in general is crucial in identifying serious problems that may not have been previously reported. Efforts have been made by the FDA in recent years to simplify the reporting process. In 1993, the FDA introduced MEDWatch, a new products reporting program. MEDWatch encourages nurses and physicians to view problem reporting as a professional responsibility and facilitates the process through the use of a one-page standard voluntary reporting form, FDA Form 3500. FDA Form 3500A is used by health care facilities and manufacturers for mandatory reporting. 78 MEDWatch forms may be obtained by calling 1-800-FDA-1088 and may be filed manually with the FDA or electronically through the ECRI Computerized Problem Reporting System (CPRS). 79



E C R I is a n o n p r o f i t a g e n c y that has gathered and investigated reports o f m e d i c a l d e v i c e p r o b l e m s through its international P r o b l e m R e p o r t i n g Syst e m since 1971; the a g e n c y has published thousands o f reports, including Health Devices Alerts. M a n y health care facilities are m e m b e r institutions o f E C R I , v o l u n t a r y or m a n d a t o r y M E D W a t c h forms filed with the E C R I C P R S are automatically filed by the E C R I with the m a n u f a c t u r e r and/or the F D A . E C R I maintains data bases o f reported dev i c e - r e l a t e d i n c i d e n t s , and r e q u e s t e d data base searches are a benefit o f E C R I m e m b e r s h i p . Strict confidentiality regarding the n a m e s o f reporting institutions or persons is maintained. 79


Rare complications o f V A D s p o s e potentially serious health risks to patients. K n o w l e d g e and awareness o f these c o m p l i c a t i o n s w h e n d i a g n o s i n g causes o f V A D malfunction can contribute to their accurate identification and appropriate m a n a g e ment. Consistent d o c u m e n t a t i o n and reporting o f u n t o w a r d V A D e v e n t s w i l l h e l p to e n s u r e the safety and efficacy o f these products. ACKNOWLE DG M ENT

The author thanks Teresa Knoop, MSN, RN, for her review of the manuscript and Lana Finch, MA, for her artwork.

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