BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 1801775 · Received August 16, 2010

    Report

    Report Number
    3005099803-2010-03387
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (WON'T BOW). A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELTED EXTRUSION, CREATED A TEAR MEASURING APPROXIMATELY 9MM PROXIMALLY FROM THE DISTAL PIERCE HOLE. THIS TEAR CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE AND SHORTENED THE EXPOSED CUTTING WIRE LENGTH, WHICH NOW DOES NOT MEET SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT MEET THE BOWING SPECIFICATION AS A RESULT OF THE MELTED/SPLIT EXTRUSION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE CUT WIRE WOULD NOT BOW, HOWEVER, THIS WAS ATTRIBUTED TO MELTED/SPLIT EXTRUSION. . DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED, THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. 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 A DREAMTOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, TO TREAT A BILIARY STRICTURE DUE TO CHOLANGIOCARCINOMA. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS POSITIONED AT THE PAPILLA. THE PHYSICIAN ATTEMPTED TO BOW THE DEVICE AND IT WOULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; MELTED/SPLIT EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DREAMTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584040 12924197

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR