BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1063806 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01720
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 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 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VEIN SIDE OF THE LEFT ANTEBRACHIAL ARTERIO-VENOUS FISTULA (AVF). THE 6.0X20MM STERLING OVER-THE-WIRE BALLOON WAS USED TO DILATE THE LESION IN SHUNT OF HEMODIALYSIS AND WAS RUPTURED AT 12ATMS ON THE SECOND INFLATION. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 6.00X40MM NON BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUANEOUS DQY BOSTON SCIENTIFIC NA 11233031

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR INTRODUCER SHEATH: MOSQUITO 4FR| GUIDEWIRE: TRANSEND 14/135CM| PATHBLAZER 6X40MM