RELIEVA FLEX SINUS GUIDE CATHETER

Description of Event or Problem

ACCLARENT WAS INFORMED OF AN EVENT THAT WAS SAID TO HAVE OCCURRED DURING A PROCEDURE IN WHICH RELIEVA FLEX SINUS GUIDE CATHETERS WERE SAID TO HAVE BEEN USED. THE USER FACILITY REPORTED THAT DURING A BALLOON SINUPLASTY OF THE MAXILLARY SINUS RECESS, THE DISTAL BLUE END OF THE SINUS GUIDE CATHETER DETACHED FROM THE DISTAL END OF THE CATHETER. AT THE TIME OF THE PROCEDURE, THE PHYSICIAN IDENTIFIED THE DETACHMENT AND VISUALIZED THE DETACHED TIP WITH AN ENDOSCOPE. THE DETACHED TIP WAS RECOVERED BY THE PHYSICIAN USING AN UNKNOWN PAIR OF SURGICAL FORCEPS. A SECOND FLEX SINUS GUIDE CATHETER WAS USED AND IT TOO REPORTEDLY DETACHED AND WAS RECOVERED USING FORCEPS. NO PATIENT INJURY WAS REPORTED IN EITHER OF THESE 2 INSTANCES OF TIP SEPARATION, HOWEVER THE PHYSICIAN ELECTED TO ABANDON THE BALLOON SINUPLASTY PROCEDURE AFTER THE SECOND OCCURRENCE AND THE PATIENT WAS TREATED WITH FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS).

Additional Manufacturer Narrative

THE SUBJECT DEVICES ARE BEING RETURNED FOR EVALUATION. REVIEW OF MANUFACTURING RECORDS ASSOCIATED WITH THE SUBJECT DEVICES DID NOT DETECT ANY MANUFACTURING ANOMALIES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE EVALUATION FOLLOWING RECEIPT OF THE DEVICES. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.