BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1051560 · Received May 19, 2008

    Report

    Report Number
    2134265-2008-01430
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X20MM STERLING OVER-THE-WIRE BALLOON CATHETER WAS USED FOR PREDILATION AND UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMS. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PT AND THE BALLOON RUPTURE WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS LISTED A "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11129802

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR KANEKA BALLOON CATHETER| JOHNSON AND JOHNSON STENT| MEDIKIT INTRODUCER SHEATH| SJM GUIDEWIRE