FDA Warns Of Coating Separation Risks For Intravascular Devices
This article was originally published in The Gray Sheet
The agency's alert, which is not tied to any specific manufacturer or product, states that peeling coatings have led to 11 recalls since 2010 and 500 adverse event reports since 2014.
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Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.
After discovering a correlation between certain chemically coated devices and serious adverse events, the agency has issued a couple of final guidance documents, including a labeling guidance to increase public awareness of the risks. The coating is meant to help physicians more easily slide devices – such as catheters and guidewires – into patients, but in some cases they’ve been associated with obstruction of blood vessels, stroke and death.
US FDA issued two draft guidelines June 14 addressing labeling and performance testing for guidewires and other interventional vascular devices. The draft recommendations address risks that have been identified in recent years resulting from the separation of coating material from the devices during deployment.