BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1161566 · Received September 15, 2008

    Report

    Report Number
    2134265-2008-02649
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. DURING "AIR BLEEDING," AIR CAME INTO THE F/G STERLING OTW 9.0 X 60/135 (5F). A PINHOLE RUPTURE WAS SUSPECTED. THE BALLOON WOULD NOT INFLATE AT ALL. THE BALLOON WAS CHANGED TO A 9.0X4MM STERLING AND THE PROCEDURE WAS CONTINUED. THE PATIENT STATUS IS "NO PROBLEM" WITH NO COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION NA 11029316

    Patients

    Seq Age Sex Outcome Treatment
    1