BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME? RX 44

    MDR report key: 3172430 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05265
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH OF THE DEVICE WAS TWISTED, THE CUTTING WIRE WAS BLACKENED WITH RESIDUES AND THE WORKING LENGTH WAS TORN/MELTED AT THE DISTAL PIERCE HOLE, DISPLACING THE CUTTING WIRE APPROXIMATELY 10 MM. THE EXPOSED CUTTING WIRE LENGTH AND TORN/MELTED WORKING LENGTH WERE MEASURED, AND IT WAS FOUND THAT THE CUTTING WIRE LENGTH WAS WITHIN SPECIFICATIONS BEFORE BEING DISPLACED DUE TO THE CATHETER TEAR. FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WOULD NOT BOW SINCE THE TORN/MELTED WORKING LENGTH SHORTENED THE EXPOSED CUTTING WIRE, WHICH IMPEDED BOWING OF THE DEVICE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE PROCEDURAL OR ANATOMICAL FACTORS COULD HAVE AFFECTED THE DEVICE INTEGRITY AND ITS PERFORMANCE. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE DEVICE FAILED TO BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273618 AUTOTOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170 15624526

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR