BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SHINCTEROTOME

    MDR report key: 1060231 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00691
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF LOT NUMBER WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. A VISUAL EVAL FOUND RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE, THE WORKING LENGTH WAS SEVERELY TWISTED & BENT, THE EXPOSED CUTTING WIRE WAS BROKEN AND THE REMAINING PART OF THE CUTTING WIRE HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. SINCE THE PRODUCT IS 100% INSPECTED DURING MANUFACTURING, THE TWIST AND BEND OBSERVED ARE LIKELY DUE TO THE CUSTOMER USAGE/HANDLING DURING THE PROCEDURE. DURING ANALYSIS, THE RETRACTED CUTTING WIRE WAS PUSHED OUT OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. A SECTION OF THE BROKEN CUTTING WIRE ANCHORED TO THE NOTCH IN THE DISTAL PIERCE HOLE APPEARED BURNT/BLACKENED. THE CUTTING WIRE WAS MEASURED TO HAVE BROKEN AT APPROX 15 MM FROM THE DISTAL PIERCE HOLE. THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BLACKENED. EXAMINING THE BROKEN ENDS OF THE CUTTING WIRE, IT APPEARS THAT THE WIRE WAS OVERHEATED/GROUNDED AGAINST SOME PART OF THE SCOPE. THE DIRECTIONS FOR USE (DFU) CAUTION USER TO "VERIFY THAT THE CUTTING WIRE HAS EXITED THE ENDOSCOPE BY VISUALIZING IT ON THE ENDOSCOPE MONITOR. FAILURE TO DO SO MAY RESULT IN CONTACT BETWEEN THE CUTTING WIRE AND THE ENDOSCOPE WHILE ELECTRICAL CURRENT IS APPLIED. THIS MAY CAUSE GROUNDING, WHICH CAN RESULT IN PT INJURY, OPERATOR INJURY, A BROKEN CUTTING WIRE, AND/OR DAMAGE TO THE ENDOSCOPE." THE MOST PROBABLE ROOT CAUSE OF BROKEN WIRE COMPLAINT IS USER ERROR DUE TO THE PHYSICIAN GROUNDING WIRE AGAINST SOME PART OF THE ENDOSCOPE OR USING IMPROPER POWER SETTINGS ON THE GENERATOR. [SEE SCANNED PAGE].

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), WHEN THEY BOWED THE HYDRATOME RX SPHINCTEROTOME THE CUT WIRE BROKE INSIDE THE PT. THE DEVICE WAS REMOVED FROM THE PT, THE BROKEN WIRE WAS STILL ATTACHED. THE PHYSICIAN COMPLETED THE CASE WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11652574

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR