BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 15710551 · Received November 1, 2022

    Report

    Report Number
    2015691-2022-08940
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Report Date
    November 9, 2022
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    UDI-DI
    00690103205213
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CAPA TO ADDRESS THIS ISSUE IS CURRENTLY IN ITS IMPLEMENTATION PHASE. THE CAPA INVESTIGATION CONCLUDED THAT THE ROOT CAUSE IS EXPOSURE OF LATEX TO OZONE, WHICH CAN HAPPEN WHEN THE POUCH PACKAGED DEVICE IS STORED IN ROOMS WITH HIGH ENERGY IONIZING RADIATION SOURCES THAT COULD GENERATE OZONE E.G. FLUOROSCOPY MACHINES, X RAY MACHINES, UV LIGHTS, HVAC SANITATION EQUIPMENT, ETC. AS A RESULT, FCA 90905 WAS VOLUNTARILY INITIATED INSTRUCTING CUSTOMERS TO RETURN ANY PRODUCT WHICH HAS BEEN STORED IN THE SAME ROOM AS HIGH ENERGY IONIZING RADIATION SOURCES WHICH EMIT OZONE.

    Additional Manufacturer Narrative · 0

    OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL: 120804F EMBOLECTOMY CATHETER IN A SEALED TYVEK POUCH FROM THE REPORTED LOT NUMBER. THE BALLOON LATEX APPEARED DETERIORATED WITH MULTIPLE CRACKS AND TEARS EVIDENT. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM THE PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEARS, WHICH DID NOT APPEAR TO MATCH. BALLOON LATEX ALSO APPEARED TO BE MISSING AT THE DISTAL TIP. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF DEFECTIVE PRODUCT WAS CONFIRMED ON EVALUATION. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER FOUND 3 MODEL: 120804FP FOGARTY CATHETERS FROM LOT: 63776283 TO BE DEFECTIVE. THEY REMOVED ANOTHER QUANTITY 10 OF THE SAME LOT FROM THE SHELVES FOR LOSS OF CONFIDENCE. PER ADDITIONAL FOLLOW-UP, THE CUSTOMER CLARIFIED THERE WAS NOT A GREAT DEAL OF SUPPORTING PAPERWORK OR COMMUNICATION BEYOND THE INFORMATION HE REPORTED. THE BEST HE CAN DETERMINE FOR THIS EVENT IS THAT SEVERAL CATHETERS WERE OPENED, TESTED ON THE BACK TABLE, AND FAILED. THEREFORE, THEY PULLED THE REST OF THOSE LOTS OFF THE SHELVES AND OBSERVED THAT THEY LOOKED DEFECTIVE IN THE PACKAGING. IT IS NOTED THAT HE COULD NOT CONFIRM THAT TO BE AN ACCURATE DEPICTION OF WHAT OCCURRED. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR ONE OF THE SHELF STOCK CATHETERS, MODEL: 120804FP FROM LOT: 63776283.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458073 FOGARTY ARTERIAL EMBOLECTOMY CATHETER FOGARTY EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 120804FP 63776283 00690103205213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown