FDA warns on intravascular device coating separation issues

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 “...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Catheters Food & Drug Administration (FDA) Vascular Source Type: news