BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1063810 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01723
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 29, 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

    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 PRODUCT 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 LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. FOLLOWING THE GUIDE WIRE CROSSING THE LESION, THE DEVICE WAS IN PLACE AND WAS INFLATED. UPON THE 1ST INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE BALLOON WAS REMOVED INTACT AND THE BALLOON RUPTURE WAS CONFIRMED OUTSIDE THE BODY. THE LESION WAS DILATED WITH A DIFFERENT DEVICE, AND AN UNK STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PT STATUS IS LISTED AS GOOD WITH NO COMPLICATIONS 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 11100730

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR