BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1242982 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06608
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INJURY TO USER. WIRE, BROKEN. THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    NOTE : THIS REPORT PERTAINS TO THE SECOND OF TWO MALFUNCTIONS OCCURRING DURING THE PROCEDURE. A SECOND STONETOME SPHINCTEROTOME WAS ADVANCED TO THE BILIARY DUCT BUT THE WIRE BROKE AS THE PHYSICIAN ATTEMPTED TO BOW THE DEVICE. AS THE PHYSICIAN WAS SLOWLY WITHDRAWING THE DEVICE THROUGH THE SCOPE, THE WIRE PUNCTURED HIS SKIN BELOW THE FINGER NAIL. THE PHYSICIAN CHANGED HIS GLOVES AND WAS ABLE TO COMPLETE THE PROCEDURE WITH A THIRD DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-06609 FOR A DESCRIPTION OF THE FIRST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION 3515 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other