BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1220277 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04178
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 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 (PTA) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOTIC LESION BEING TREATED WAS LOCATED IN AN ANASTOMOTIC STRICTURE IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT ANTEBRACHIUM ARTERY. THE PHYSICIAN ADVANCED THE 5X40MM STERLING BALLOON CATHETER TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 6 ATMS FOR APPROXIMATELY FIFTEEN SECONDS AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. PT STATUS IS REPORTED 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 11625605

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND 0.018INCH 135 CM GUIDEWIRE| MEDIKIT 4F3CM INTRODUCTION SHEATH