BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1060788 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00693
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 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
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF LOT NUMBER WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. DEVICE WAS RECEIVED FOR ANALYSIS, RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE. A VISUAL EVALUATION FOUND THAT THE WORKING LENGTH WAS TWISTED, 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 MFG, THE TWIST OBSERVED IS 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. THE CUTTING WIRE WAS MEASURED TO HAVE BROKEN AT APPROX 19MM 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 GROUNDED AGAINST SOME PART OF THE SCOPE. 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. THE TOME CUTTING WIRE SHOWS EVIDENCE OF WIRE BLACKENED AT THE BURNT ENDS OF THE BROKEN WIRE. 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." EITHER THE POSITIONING OF THE TOME ALLOWED THE ENERGIZED CUTTING WIRE TO BE IN CONTACT WITH THE SCOPE, OR IMPROPER POWER SETTINGS WERE USED ON THE GENERATOR. CUSTOMER COMPLAINT ON BROKEN CUTTING WIRE IS CONFIRMED AND IS BEING CLASSIFIED AS USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE THE CUTTING WIRE ON THE AUTOTOME RX SPHINCTEROME BROKE. PRIOR TO INSERTION INTO THE PT THE CUTTING WIRE WAS CONFIRMED TO BE OPERATING CORRECTLY. THE DEVICE WAS INSERTED OVER THE GUIDEWIRE AND THE HANDLE WAS ENGAGED TO SET UP THE CUTTING WIRE, WHEN IT WAS NOTICED THAT THE CUTTING WIRE WAS BROKEN. THE DEVICE DID NOT REMAIN IN THE PT AS A PORTION REMAINED ATTACHED TO THE DEVICE AND WAS ABLE TO BE REMOVED AS ONE UNIT. THE BREAK HAD OCCURRED PRIOR TO THE USAGE OF POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545180 11232465

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK