FDA Safety Communication: Catheter Entrapment with the ev3 Onyx Liquid Embolic System
MedSun: Newsletter #74, July 2012

FDA MedWatch Safety Alert

The FDA is informing physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material. The clinical data submitted by the manufacturer prior to marketing included cases where the delivery catheter was difficult to remove, but in all cases the catheter was removed without any adverse patient events. The original product labeling did not reflect the risks related to catheter entrapment but new labeling will include these risks as well as recommendations to help minimize that risk.

Additional Information:

FDA MedWatch Safety Alert. FDA Safety Communication: Catheter Entrapment with the ev3 Onyx Liquid Embolic System. June 29, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310121.htm


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