RELIEVA SOLO PRO 7X24MM BALLOON CATHETER

Additional Manufacturer Narrative

A THOROUGH INVESTIGATION INTO THE ASSOCIATED MATERIALS, METHOD/PROCESS, ENVIRONMENTAL CONTROLS, HISTORICAL DATA, PROBABLE ROOT CAUSE, AND PRODUCT IMPACT WAS PERFORMED. NO CONTRIBUTING ISSUES WERE IDENTIFIED. THIS IS THE FIRST CUSTOMER COMPLAINT FOR DETACHED DISTAL FILLET FOR SOLO PRO. (B)(4). NO DESIGN CHANGES/MODIFICATIONS TO SOLO PRO DEVICE HAS BEEN MADE SINCE ITS INTRODUCTION. THE SUSPECTED ROOT CAUSE FOR THE DETACHMENT OF THE FILLET IS THAT THE DEVICE ENCOUNTERED EXCESSIVE FORCE/MANIPULATION/KINKING UPON MULTIPLE INSERTIONS, WHICH COMPROMISED THE FILLET'S BOND SHARED WITH THE SHOULDER OF THE BALLOON/DISTAL TIP OF THE INNER SHAFT. IT IS SUSPECTED THAT DUE TO EITHER INTERACTION WITH UNIQUE PT ANATOMY, OR POSSIBLE UNSUPPORTED GUIDEWIRE USAGE DURING ONE OF THE SINUS INSERTIONS. NOTE, ALL SOLO PRO FILLET BONDS ARE 100% INSPECTED. IN ADDITION, NO DISTAL ADHESIVE FILLET DETACHMENTS HAVE BEEN NOTED DURING LOT TESTING FROM SOLO PRO'S LAUNCH IN (B)(6) 2008 TO PRESENT. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADD'L INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

Description of Event or Problem

(UPDATED BY ACCLARENT). THIS EVENT OCCURRED DURING A PROCEDURE PERFORMED ON (B)(6) 2011, WITH NO INJURY ASSOCIATED. DURING A BILATERAL FRONTAL SINUS SURGERY, THE PHYSICIAN NOTED A SMALL FOREIGN OBJECT ON THE DEVICE TRAY/TOWEL, SUSPECTED TO HAVE DETACHED FROM AN ACCLARENT PRODUCT. THE OBJECT, ALONG WITH AN ASSOCIATED 7X24 SOLO PRO BALLOON CATHETER, WERE RETURNED TO ACCLARENT ON (B)(6) 2011, FOR EVAL. UPON DEVICE EVAL, THE OBJECT WAS CONFIRMED TO BE A DISTAL FILLET MADE OF ADHESIVE. THE FILLET WAS CONICAL/TUBULAR IN APPEARANCE, AND WAS APPROX 1X1 MM IN SIZE. (THE DISTAL FILLET DOES NOT PROVIDE STRUCTURAL SUPPORT. IT'S FUNCTION IS TO PROVIDE A SMOOTH TRANSITION BETWEEN THE FLEXIBLE SHAFT AND THE BALLOON). ACCLARENT'S (B)(4) DISCUSSED THE EVENT WITH THE PHYSICIAN. THROUGH HIS DISCUSSION, HE LEARNED THAT ONCE THE DETACHED FOREIGN OBJECT (DISTAL FILLET) WAS NOTED, A SEPARATE SOLO PRO BALLOON CATHETER WAS USED TO SUCCESSFULLY TREAT THE PT. IN ADDITION TO THE COPY OF THE MEDWATCH FORM FILED BY THE FACILITY, ACCLARENT RECEIVED AN FDA LETTER ON (B)(6) 2011 FROM (B)(6). THE LETTER (REF REPORT # (B)(4)) HAD 6 QUESTIONS, WITH A RESPONSE REQUESTED NO LATER THAN (B)(6) 2011. NOTE, THE FACILITY PROVIDED AN INCORRECT DEVICE DESCRIPTION OF THE COMPLAINT DEVICE. THE DEVICE DESCRIPTION NOTED AN "F70 GUIDE." PLEASE NOTE, AN ACCLARENT "7X24 MM SOLO PRO BALLOON CATHETER" WAS THE PRODUCT OF CONCERN. IN ADDITION, THE PRODUCT CODE PROVIDED IN ASSOCIATED INQUIRY LETTER FROM THE FDA (REF (B)(4)) WAS LISTED AS "KTI", WHICH DENOTES A CLASS II PRODUCT FOR THE "AIRWAY." THE APPROPRIATE CODE SHOULD BE THE CLASS I CODE, "LRC", WHICH IS FOR THE SINUS.