BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME? RX 44

    MDR report key: 3152777 · Received June 8, 2013

    Report

    Report Number
    3005099803-2013-04325
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT: CATHETER TORN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH OF THE DEVICE WAS TWISTED, AND THERE WERE TWO PRONOUNCED KINKS IN THE CATHETER AND WIRE. THE DISTAL PIERCE HOLE WAS FOUND TO BE MELTED/TORN. THE CUTTING WIRE WAS DISPLACED APPROXIMATELY 9 MM DUE TO THE MELTED/TORN DISTAL PIERCE HOLE. THEREFORE, THE EXPOSED PORTION OF THE CUTTING WIRE WAS SHORTENED, WHICH CAUSED THE DEVICE NOT TO BOW. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT AS PROCEDURAL OR ANATOMICAL FACTORS COULD HAVE AFFECTED THE DEVICE INTEGRITY AND 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 A DREAMTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS POSITIONED INSIDE THE PATIENT, WHEN THE HANDLE WAS ACTUATED, THE DEVICE FAILED TO BOW. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME. 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 FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254487 DREAMTOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584050 15552231

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR