BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1133735 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02395
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 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

    DEVICE EVALUATION: THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE MFG RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    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 IN THE HEMODIALYSIS SHUNT WAS LOCATED IN A MODERATE CALCIFIED AND SEVERELY TORTUOUS UNIDENTIFIED ARTERY. THE PHYSICIAN ADVANCED THE 5.0X40MM STERLING OTW BALLOON CATHETER TO THE LESION AND ON THE FIRST AND SECOND INFLATIONS, INFLATED THE BALLOON TO 13 ATMS FOR APPROX FIVE SECONDS ON EACH INFLATION. ON THE THIRD INFLATION, THE PHYSICIAN INFLATED THE BALLOON TO 13 ATMS FOR APPROX FIVE SECONDS AND THE BALLOON RUPTURED. THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS BALLOON CATHETER. 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 11641486

    Patients

    Seq Age Sex Outcome Treatment
    1