BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3161546 · Received June 11, 2013

    Report

    Report Number
    3002648230-2013-00091
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CATHETER WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED TRACES OF BLOOD INSIDE THE INNER BALLOON OF THE CATHETER. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 5 INJECTIONS. PRESSURE TEST REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN, HOWEVER, THE BALLOONS INTEGRITY WAS INTACT; NO BREACH OBSERVED. DISSECTION SHOWED A GUIDE WIRE LUMEN BREACH AT 1.13 INCHES FROM THE TIP INSIDE THE HEAT SHRINK. DISSECTION OF THE HANDLE DID NOT SHOW TRACES OF BLOOD. AN INTERNAL CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO INVESTIGATE THE CONDITION FOUND. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATES THAT THE CATHETER TRIGGERED SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) DURING THE CRYOABLATION PROCEDURE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. DURING THE CASE, THE PATIENT DESCRIBED NAUSEA AND THE CASE WAS STOPPED. PATIENT WAS IN GOOD CONDITION WITH NO INJURY. WHEN THE DEVICE WAS RETURNED, PRESSURE TESTING REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262323 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR