BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1002735 · Received February 26, 2008

    Report

    Report Number
    3005099803-2008-00210
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    December 23, 2007
    Report Date
    January 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. ALTHOUGH THE ROOT CAUSE OF THE EVENT IS UNKNOWN, POSSIBLE CAUSES INCLUDE: IMPROPER TOME POSITION ALLOWED THE CUTTING WIRE TO ABUT THE ENDOSCOPE, WHICH RESULTED IN A SHORT CIRCUIT, AND EXCESSIVE POWER APPLIED TO THE CUTTING WIRE DUE TO IMPROPER GENERATOR SETTINGS. A SEARCH OF THE COMPLAINT DATABASE IDENTIFIED ONE OTHER COMPLAINT FROM THE SAME LOT AND THE SAME ISSUE. THE DECEMBER 2007 15-MONTH AUTOTOME SPHINCTEROTOMES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT UNKNOWN) IN LATE 2007. ACCORDING TO THE COMPLAINANT, "THE WIRE WAS CUT DURING THE SPHINCTEROTOMY PROCEDURE." A SECOND AUTOTOME RX SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE. NO PATENT COMPILATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545150 11058031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK