BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 2782094 · Received October 3, 2012

    Report

    Report Number
    1820334-2012-00453
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 11, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K073378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVAL OF FOREIGN BODY IS NOT LABELED. BALLOON RUPTURE IS ADDRESSED IN THE IFU. PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. PER DFMEA (DESIGN FAILURE MODES AND EFFECT ANALYSIS) BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING PERFORMED. THE RATED BURST PRESSURE IS DOCUMENTED IN THE IFU AND LABEL. THE DEVICE IS INSPECTED PER QUALITY CONTROL SPECIFICATIONS TO ENSURE BONDS AND BALLOONS ARE UNDAMAGED. EACH DEVICE IS LEAK TESTED. EACH DEVICE IS SHIPPED WITH AN IFU THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. THE RETURNED PRODUCT IS TOO EXTENSIVELY DAMAGED TO MAKE ANY EXAMINATION. IN THE ABSENCE OF EXTERNAL RESTRAINTS THE BALLOON IS DESIGNED TO BURST IN A LONGITUDINAL DIRECTION. THE BALLOON RUPTURE ULTIMATELY RESULTED IN DIFFICULTY REMOVING THE DEVICE. INFLATION PRESSURES WERE NOT PROVIDED AND THE PATIENT ANATOMY WAS NOT DESCRIBED. IN THE ABSENCE OF COMPLAINT DETAIL IT IS DIFFICULT TO DETERMINE FACTORS OTHER THAN PATIENT ANATOMY THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. DUE TO THIS ABSENCE OF DETAIL THE ROOT CAUSE FOR THIS COMPLAINT IS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ANALYSIS.

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY OF RIGHT SFA, THE BALLOON RUPTURED CIRCUMFERENTIALLY AND COULD NOT BE REMOVED. A PIECE OF THE BALLOON REMAINED INSIDE THE PATIENT. PER THE INFORMATION PROVIDED, A PUNCTURE WAS MADE ON OPPOSITE SIDE, AND THE PIECE OF THE BALLOON WAS REMOVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 2754726

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention