BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1080632 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02035
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 21, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO INFLATING THE 5.0X100MM STERLING OVER-THE-WIRE BALLOON, THE PHYSICIAN DREW NEGATIVE PRESSURE TO THE BALLOON AND FOUND THAT BLOOD FLEW BACK THROUGH THE INFLATION LUMEN. THE DEVICE WAS REMOVED OUTSIDE OF THE PATIENT IN ORDER TO CHECK THE CONDITION OF THE DEVICE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IN WATER AND AN AIR LEAK WAS CONFIRMED. THE PHYSICIAN SUSPECTED THAT THE STERLING BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11059950

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: EVEREST| STENT: SMART 6.0*100MM| GUIDEWIRE: TREASURE