BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 2122417 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-01885
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH WAS TWISTED AND THE DISTAL TIP OF THE DEVICE WAS CUT OFF. THE CUTTING WIRE WAS INTACT BUT DISCOLORED FROM USE. ANALYZING THE DISTAL TIP, THE CUTTING WIRE APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION FROM THE DISTAL TIP TO THE PROXIMAL PIERCE HOLE. A FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE SPLIT/MELTED EXTRUSION IS LIKELY DUE TO ANATOMICAL/PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED AT THE COMMON BILE DUCT. HOWEVER, WHEN THE PHYSICIAN ACTUATED THE HANDLE, THE DEVICE FAILED TO BOW. THE DEVICE WAS REMOVED FROM THE PATIENT. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE. THE USER CUT OPEN THE CATHETER AND VERIFIED THAT NO PORTION OF THE CUTTING WIRE HAD BROKEN. THE PROCEDURE OUTCOME WAS NOT PROVIDED. 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." BASED UPON THE INVESTIGATION RESULTS, WHICH INDICATE THAT THE CUTTING WIRE APPEARS TO HAVE MELTED/SPLIT THE EXTRUSION OF THE CATHETER, THIS IS NOW A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00573080 13489117

    Patients

    Seq Age Sex Outcome Treatment
    1