BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2941941 · Received February 4, 2013

    Report

    Report Number
    3002648230-2013-00017
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 26, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. BIN FILES CONFIRM SYSTEM NOTICE MESSAGE 50005 "LEAK DETECTION" AT INJECTION 10. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 11 INJECTIONS. VISUAL INSPECTION SHOWED TRACES OF BLOOD INSIDE THE INNER BALLOON. PRESSURE TESTS REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN, HOWEVER, THE BALLOONS INTEGRITY WAS INTACT WITH NO BREACH OBSERVED. DISSECTION SHOWED A GUIDE WIRE LUMEN BREACH AT 1.17 INCHES PROXIMAL FROM THE TIP. AN INTERNAL CAPA HAS BEEN INITIATED TO INVESTIGATE THE CONDITION FOUND. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    AFTER THE SIXTH ABLATION DURING A CRYOABLATION PROCEDURE, THE USER RECEIVED SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION). THE CRYOABLATION CATHETER WAS REPLACED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENT OCCURRED. WHEN THE DEVICE WAS RETURNED, PRESSURE TESTING REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN OF THE CRYOABLATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46654 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1