RELIEVA FLEX SINUS GUIDE CATHETER

Additional Manufacturer Narrative

ACCLARENT RECEIVED THE SUBJECT DEVICE, THE RELIEVA FLEX® SINUS GUIDE CATHETER. EVALUATION OF THE RETURNED PRODUCT WAS COMPLETED ON JULY 16, 2015 AND REVEALED THAT THE DISTAL TIP WAS SEPARATED FROM THE NYLON SHAFT OF THE GUIDE CATHETER. THE EVALUATION FOUND THE NYLON SHAFT MATERIAL BETWEEN THE LINEAR AND NYLON SECTIONS WAS PEELED OFF FROM THE PEBAX, AND THE NYLON MATERIALS WERE EXPOSED ON THE LUMEN OF THE GUIDE CATHETER. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. CONCOMITANT MEDICAL PRODUCTS: RELIEVA SINUS INFLATION DEVICE (LOT# 96427016), RELIEVA SOLO PRO SINUS BALLOON CATHETER 5X16MM (LOT# 130823F), RELIEVA SIDEKICK LP (LOT# 120710H), AND STEEL INSTRUMENTS OF UNKNOWN TYPE.

Description of Event or Problem

ACCLARENT WAS INFORMED OF AN EVENT THAT WAS SAID TO HAVE OCCURRED DURING A PROCEDURE IN WHICH A RELIEVA FLEX SINUS GUIDE CATHETER WAS SAID TO HAVE BEEN USED. THE USER FACILITY REPORTED THAT DURING A BALLOON SINUPLASTY OF THE RIGHT MAXILLARY SINUS OF A PEDIATRIC PATIENT, THERE WAS TIGHT SPACE WITH TISSUE EDEMA THAT WAS SAID TO MAKE IT VERY DIFFICULT TO POSITION THE GUIDE CATHETER TIP. WHEN ATTEMPTING TO RETRACT THE GUIDE CATHETER MEDIALLY AND SUPERIORLY THE SURGEON NOTED THAT THE BLUE TIP OF THE GUIDE CATHETER HAD SLIGHTLY CRACKED. THE BALLOON WAS SUCCESSFULLY INFLATED, AND THE DEVICE WAS REMOVED FROM THE NOSE. OUTSIDE OF THE PATIENT'S ANATOMY, THE SURGEON PROCEEDED TO WITHDRAW THE BALLOON CATHETER FROM THE FLEX GUIDE CATHETER, AND THE BLUE MARKER MATERIAL TORE OFF FROM THE DISTAL TIP. THE SURGEON CHECKED THOROUGHLY IN THE NOSE AND CONFIRMED THAT NO BLUE MARKER MATERIAL REMAINED IN THE PATIENT'S ANATOMY. NO PATIENT INJURY WAS REPORTED AND THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A REPLACEMENT GUIDE CATHETER.