BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 2040237 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-01164
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUTTING WIRE WAS DISCOLORED, AND THE CUTTING WIRE APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE SPLIT EXTRUSION CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE AND ALTERED THE EXPOSED CUTTING WIRE LENGTH TO BECOME SHORTER. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DOES NOT MEET THE BOWING SPECIFICATION OF 90 DEGREE MINIMUM DUE TO THE MELTED EXTRUSION (ELONGATED DISTAL PIERCE HOLE) AND THE ALTERED EXPOSED CUTTING WIRE LENGTH. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE FAILED TO BOW COMPLETELY. HOWEVER, THIS CONDITION WAS ATTRIBUTED TO THE MELTED EXTRUSION AND THE ALTERED EXPOSED CUT WIRE LENGTH. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW FOUND THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING A SPHINCTEROTOMY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO BOW COMPLETELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX SPHINCTEROTOME. 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 STABLE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS THAT THE EXTRUSION IS MELTED/SPLIT.

    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 13818086

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR