The FDA said today that clinicians using intravascular medical devices such as catheters and guidewires should be aware of issues that can arise when their hydrophilic or hydrophobic lubricious coatings separate.
The coatings reduce friction between the device and the blood vessel, but when the coating begins to flake, peel or slough off, the federal watchdog said patients could be at risk of serious injury.
The agency warned of the issue in a safety communication, specifically mentioning intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems used during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems.
Coating separation can occur due to a number of different factors, the FDA said, ranging from personal technique and patient anatomy issues to improper preconditioning or storage conditions for the devices.
The federal watchdog said it issued 11 recalls since 2010 for devices with the coatings peeling or flaking off, the majority of which were guidewires. Also included in recalls were devices including sheaths, retrieval devices and embolization device delivery wires.
The agency said it has received over 500 medical device reports since 2014 describing separation of such coatings, the majority of which were submitted for vascular guidewires. A total 75% of the cases described device malfunctions, though the FDA says the reports are not definitive evidence of “a faulty or defective medical device, and cannot be used to establish or compare rates of event occurrence.”
Of the MDRs, 11 described patient deaths, 2 of which were not attributed to device coating. Also mentioned in the MDRs were the persistence of coating fragments in patients which required surgical interventions to correct.
The federal watchdog did not name any specific manufacturers as having higher-risks than other devices, and said risks can be mitigated through proper device selection, preparation and maintenance.
The FDA said to follow manufacturer’s instructions for storage and preconditioning steps, to be cautious when using multiple devices together and to be aware of the risks of altering the shape through bending or twisting the devices.
The agency said the warning was meant to reduce the risk of such failures, but that it believed the overall benefits of the devices and coatings outweighed the risk.