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FDA cautions device users on fracture risk

This article was originally published in The Gray Sheet

Executive Summary

FDA warns health care practitioners Jan. 15 of risks associated with device fragments breaking off inside patients and not being retrieved. The agency's device center receives nearly 1,000 reports a year of adverse events including infection, tissue perforation, blood vessel obstruction and death resulting from unretrieved fragments, according to the public health 1notification, which advises physicians on prevention and how to respond if needed. According to an agency spokeswoman, fracture risk is a problem for devices across-the-board, but the highest incidence of reports relates to coronary catheter guidewires, implanted intravascular ports with catheters and bone screws. "This may reflect the high volume of usage of these devices rather than an actual high rate of fracture," she said. "In addition, the difficulty in removing fragments of these devices may contribute to their being unretrieved.
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