BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1172137 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02708
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 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

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC LESION IS LOCATED IN THE SHUNT OF THE MILDLY CALCIFIED AND AVERAGE TORTUOUS ANTEBRACHIAL VEIN. THE PHYSICIAN ADVANCED THE 6X40MM STERLING BALLOON CATHETER TO THE LESION AND INFLATED THE BALLOON "BUT THE MIDDLE OF THE BALLOON DID NOT EXPAND WELL AND IT RUPTURED AT 12ATMS ON THE FIRST INFLATION". THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 6X40MM NON-BSC BALLOON CATHETER. PATIENT STATUS IS REPORTED AS "NO PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11393992

    Patients

    Seq Age Sex Outcome Treatment
    1 6X40MM SHIRANUI BALLOON CATHETER| TRANDSEND GUIDEWIRE| MOSQUITO 4FR INTRODUCER SHEATH| ENCORE 26 INFLATION DEVICE