RELIEVA SOLO PRO 6 X 16 MM BALLOON CATHETER

Additional Manufacturer Narrative

WITH REGARD TO FILLET DETACHMENT, A THROUGH INVESTIGATION INTO THE ASSOCIATED MATERIALS, METHOD/PROCESS, ENVIRONMENTAL CONTROLS, HISTORICAL DATA, PROBABLE ROOT CAUSE, AND PRODUCT IMPACT HAS BEEN PERFORMED. NO CONTRIBUTING ISSUES WERE IDENTIFIED. AS OF (B)(4) 2011, THE SOLO PRO COMPLAINT RATE FOR THIS FAILURE HAS BEEN NOTED AS 0.003%. 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 BONDS SHARED WITH THE SHOULDER OF THE BALLOON/BALLOON SHAFT. 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 OCTOBER 2008, TO PRESENT. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

Description of Event or Problem

THIS EVENT OCCURRED DURING A PROCEDURE PERFORMED ON (B)(6) 2011, WITH NO INJURY ASSOCIATED. ACCLARENT RECEIVED A COMPLAINT FOR DIFFICULT DEVICE INSERTION ON (B)(6) 2011. THE DEVICE WAS RETURNED ON (B)(4) 2011, AND EVALUATED ON (B)(4) 2011. ACCLARENT CONFIRMED THE DEVICE TO BE EXCESSIVELY MANIPULATED BY THE USER, AS DESCRIBED IN THE COMPLAINT REPORT. MULTIPLE KINKS IN THE FLEXIBLE SHAFT, A DAMAGED METAL HYPOTUBE, AND 2 MISSING ADHESIVE FILLETS WERE NOTED. DUE TO A SIMILAR MALFUNCTION ASSOCIATED WITH A MISSING FILLET WITHIN 2 YEARS ((B)(4) 2011), THIS COMPLAINT HAS BEEN DEEMED REPORTABLE. NOTE: THE FILLETS ARE CONICAL/TUBULAR IN APPEARANCE, AND ARE APPROX 1 X 1 MM IN SIZE. BOTH THE DISTAL AND PROXIMAL DO NOT PROVIDE STRUCTURAL SUPPORT. THEIR FUNCTION IS TO PROVIDE A SMOOTH TRANSITION BETWEEN THE FLEXIBLE SHAFT AND THE BALLOON.