PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM

Additional Manufacturer Narrative

CORRECTION: ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE FOR THE FOLLOWING REASON : - NO SERIOUS ADVERSE EVENT. BASED ON THIRD PARTY REPAIR / UNAUTHORIZED MANIPULATION OF MEDICAL DEVICE, AESCULAP AG IS NO LONGER LEGALLY RESPONSIBLE FOR THE AFFECTED ITEM.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT FE908K - PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AVM CLIPS STAYED OPEN AFTER BEING LOADED AND PREPARED ON THE APPLIER. FOUR (4) CLIPS WERE INITIALLY ATTEMPTED. THE PATIENT WAS REQUIRED TO RETURN TO THE OPERATING ROOM (OR) AFTER THE INTERVENTIONAL RADIOLOGY (IR) PROCEDURE. THEN, THREE (3) MORE CLIPS WERE TRIED LATER THAT SAME DAY. THE PROCEDURE HAD BEEN AN OPEN CRANIOTOMY FOR AVM RESECTION. IMPLANTATION OF ANEURYSM CLIPS INSTEAD OF AVM CLIPS WAS PERFORMED. THERE WAS AN ADDITIONAL ESTIMATED ONE (1) HOUR OF ANESTHESIA TIME AND THE NEED FOR ADDITIONAL DISSECTION OF SCAR TISSUE TO IDENTIFY THE APPROPRIATE LOCATION SINCE A CLIP COULD NOT BE USED AS A RADIOGRAPHIC MARKER. THE CURRENT STATUS OF THE PATIENT WAS NOTED AS "DOING WELL". A REVISION WAS REQUIRED. ALL INFORMATION HAS BEEN PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO.100034639 (AESCULAP AG REFERENCE NO. (B)(4) ). ASSOCIATED MEDWATCH REPORT: 9610612-2024-00051 (AESCULAP AG REFERENCE NO. (B)(4) ). INVOLVED COMPONENTS: 9610612-2023-00279 (AESCULAP AG REFERENCE NO. (B)(4) ). 9610612-2023-00280 (AESCULAP AG REFERENCE NO. (B)(4) ). 9610612-2023-00281 (AESCULAP AG REFERENCE NO. (B)(4) ). 9610612-2023-00282 (AESCULAP AG REFERENCE NO. (B)(4) ). 9610612-2023-00283 (AESCULAP AG REFERENCE NO. (B)(4) ). 9610612-2023-00284 (AESCULAP AG REFERENCE NO. (B)(4) ). 9610612-2023-00285 (AESCULAP AG REFERENCE NO. (B)(4) ).

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE MANUFACTURER HAS PERFORMED A GAUGE TEST FOR THE APPLIER AND THE RESULTS WERE NOT ACCORDING TO SPECIFICATION. IN ADDITION, A SPOT WELD WAS FOUND ON THE COLLET, INDICATING THAT THE DEVICE HAD BEEN IMPROPERLY REPAIRED. AN UNAUTHORIZED STAMP WAS DISCOVERED ON THE INSTRUMENT, WHICH DOES NOT ORIGINATE FROM AESCULAP AG. ACCORDING TO THE MANUFACTURER, COLLETS MUST NOT BE WELDED, BUT MUST BE REPLACED DURING MAINTENANCE IF A DEVIATION IS DETECTED ON THE COMPONENT. DUE TO THE DEVIATIONS ON THE PLIERS, PROPER FUNCTIONING OF THE CLIPS CAN NO LONGER BE GUARANTEED. IT CANNOT BE RULED OUT THAT THE DEFORMATION OF THE CLIPS HAS BEEN CAUSED BY THE DAMAGED PLIERS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE ABOVE-MENTIONED INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. IN GENERAL, THE INSTRUCTIONS FOR USE (IFU) MUST BE CONSIDERED TO AVOID MALFUNCTION OR DAMAGE TO THE CLIPS. INCORRECT INSERTION OF THE CLIPS INTO THE CLIP-ON PLIERS CAN LEAD TO DAMAGE. FURTHERMORE, SIGN OF A THIRD-PARTY REPAIR HAS BEEN DETECTED ON THE APPLIER, SO A PROPER FUNCTION OF THE APPLIER CANNOT BE GUARANTEED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.