BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1001245 · Received February 22, 2008

    Report

    Report Number
    3005099803-2008-00202
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    December 3, 2007
    Report Date
    January 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO; HOWEVER, EVAL OF THE RETURNED DEVICE, REVEALED A REPORTABLE MALFUNCTION. THIS REPORT IS SUBMITTED BASED ON THESE RESULTS. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE EXTRUSION WAS SPLIT AND THAT THE CUTTING WIRE AND THE EXTRUSION HAD A BLACKENED APPEARANCE. THIS INDICATED THAT EXCESSIVE ELECTRICAL CURRENT FLOWED THROUGH THE DEVICE. THE CAUSE OF THE EXCESSIVE ELECTRICAL CURRENT IS UNK, ALTHOUGH POSSIBLE CAUSES INCLUDE: IMPROPER TOME POSITION, ALLOWED THE CUTTING WIRE TO CONTACT THE ENDOSCOPE, WHICH RESULTED IN A SHORT CIRCUIT, AND EXCESSIVE POWER APPLIED TO THE CUTTING WIRE DUE TO IMPROPER GENERATOR SETTING. A REVIEW OF THE COMPLAINT DATABASE IDENTIFIED ONE ADD'L COMPLAINT REPORTED FOR THE SAME LOT (FOR A SIMILAR EVENT). THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    A STONETOME STONE REMOVAL DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (PT AGE, GENDER, AND WEIGHT UNK) IN 2007. ACCORDING TO THE COMPLAINANT, "THE CUTTING WIRE WAS NOT TIGHT ENOUGH TO BE ABLE TO CUT." THE PROCEDURE WAS COMPLETED WITH A SECOND STONETOME STONE REMOVAL DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND PT'S CONDITION WAS REPORTED AS "GOOD" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535110 9762975

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK