BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1102036 · Received August 7, 2008

    Report

    Report Number
    3005099803-2008-01543
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Report Date
    June 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURER DATE CANNOT BE DETERMINED. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE EXPOSED CUTTING WIRE MELTED THE EXTRUSION RESULTING IN A TEAR. THIS TEAR ALLOWED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY, WHICH HINDERED THE ABILITY OF THE CUTTING WIRE TO BOW WHEN ACTIVATED WITH THE HANDLE. THE CAUSE OF THE CUTTING WIRE TO MELT THE EXTRUSION IS UNKNOWN; HOWEVER, UNDER SIGNIFICANT ELECTRICAL ENERGY, THE CUTTING WIRE IS KNOWN TO GENERATE HEAT SUFFICIENT TO MELT THE PLASTIC EXTRUSION REGION. THE 2008 15-MONTH AUTOTOME SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: DATE OF THE EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TOME WOULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH A SECOND AUTOTOME RX SPHINCTEROTOME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545160 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK