BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1133731 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02392
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 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

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF BY THE USER FACILITY; 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 CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC AND CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS ANTEBRACHIAL VEIN. THE 5.0MM X 40MM STERLING BALLOON CATHETER WAS ADVANCED TO THE LESION AND REPORTED TO HAVE RUPTURED UPON THE FIRST INFLATION AT 13 ATMS; THE DURATION OF THE INFLATION IS UNK. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DIFFERENT DEVICE. NO PT INJURY OR COMPLICATIONS WERE REPORTED. THE PT'S CONDITION WAS 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 9782726

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND GUIDE WIRE| MOSQUITO INTRODUCER SHEATH