RELIEVA FLEX SINUS GUIDE CATHETER

Description of Event or Problem

ACCLARENT WAS NOTIFIED ON (B)(6) 2014, OF AN DOMESTIC EVENT THAT OCCURRED ON (B)(6) 2014 DURING A SINUS SURGICAL CSE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE BLUE GUIDE CATHETER TIP CAME OFF DURING THE PROCEDURE. THE TIP WAS RETRIEVED VERY EASILY. THERE WAS NO PT INJURY.

Additional Manufacturer Narrative

COMPLAINT DEVICE ARRIVED ON (B)(6) 2014 AND FAILURE ANALYSIS WAS PERFORMED ON (B)(6) 2014. THE RETURNED PACKAGE INCLUDED A FLEX GUIDE CATHETER M-110. THE BLUE TIP WAS DETACHED FROM THE GUIDE CATHETER AND IT WAS INSIDE THE PLASTIC CONTAINER. DELAMINATION DAMAGES WERE FOUND INSIDE THE TIP. THERE WERE SCRATCHES AND PINCHES AROUND DISTAL OF LINEAR AND BLUE TIP AREA. THERE WAS MATERIAL KNOWN AS THE NYLON MATERIAL BETWEEN LINEAR AND NYLON SECTION WHICH WAS PEELING OFF FROM THE PEBAX. BASED ON THE INVESTIGATION RESULTS, IT IS SUSPECTED THAT THE DAMAGE COULD BE THE RESULT OF USER USED EXCESSIVE FORCE TO MANIPULATE THE GUIDE CATHETER. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.