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Danger: Beware of Unretrieved Device Fragments

by Robert A. Fischer, RN, MSN

(Article reprinted from Nursing2007, Volume 37, Issue 11, p. 17.)

DURING A CARDIAC catheterization, a fractured guide wire lodged in a coronary artery, causing coronary artery perforation. Attempts to retrieve it failed, and the patient died from cardiac tamponade.

What went wrong?

An unretrieved device fragment (UDF) is a broken or fractured portion of a medical device that was never intended to remain in a person’s body for an extended time. By definition, the UDF is left in the body either because no attempt was made to retrieve it or because the attempt was unsuccessful.

In the case described above, the health care provider manipulated the guide wire into a shape for which it wasn’t designed. Weakened by the bending, the guide wire fractured during the procedure.

Catheter and guide wire fractures that result in UDFs can be caused by these inappropriate techniques:

• withdrawing a catheter through or over a needle
• shaping a device to conform to the patient’s anatomy when the device wasn’t designed to be reshaped
• using undue force and torque (rotational force) on insertion or withdrawal
• improperly manipulating a catheter
• using devices that are too small or too large
• using a device for an off-label purpose, such as using a biliary stent in the carotid arteries
• using old or worn multiple-use devices, such as endoscopes.

Also, a device that has flaws in its manufacture, design, or materials or that’s been damaged in shipment or storage may be used inadvertently.

Failure of a device can cause it to tear, shear, kink, fold, chip, break, rip, crack, or crimp and can result in UDFs.

Burns and other serious injuries

Each year, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health receives over 1,000 reports about UDFs. These reports involve many types of devices and several serious injuries and patient deaths.

Retained devices may be made of materials that aren’t intended for extended use, and their fragments may have sharp surfaces. Besides occlusion, UDFs can lead to tissue injury and other complications. For example, metallic fragments within the body may potentially move or become warm during magnetic resonance imaging. If the metal is close to a vital organ or blood vessel, it may cause serious complications. According to reports in the literature, some patients don’t know they have a potentially harmful device fragment in their body, so they don’t report it.

What can you do?

Take these steps to minimize the risks of UDFs:

• Question your patient and review his medical records for any history of retained devices or fragments. Make sure that any UDF is documented in his medical record and notify the health care provider.
• Before using it, inspect any device for breaks or other flaws. Remember, even a new device can have manufacturing flaws or be damaged during shipment or storage.
• Follow the manufacturer’s device labeling and instructions for use, insertion, and removal.
• Use best practices for patient positioning, device insertion and removal, and troubleshooting.
• Review your facility’s policies and procedures about what to do if a patient retains a device fragment.
• If a patient has a UDF, he should be informed so he can report it to other caregivers and avoid complications during future medical treatment or testing.
• Follow your facility’s policy for reporting UDFs. Also report all UDF events to the FDA through the MedWatch reporting program at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Although you need to support your health care facility’s adverse event–reporting policy, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1- 800-FDA-0178) or online at http://www.fda.gov/medwatch/how.htm. The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety, is a nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.

Robert A. Fischer is an anesthesia and central venous catheter device nurse-consultant at the Center for Devices and Radiological Health.

Updated November 22, 2007