BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 2113249 · Received June 3, 2011

    Report

    Report Number
    3005099803-2011-01806
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS BROKEN AND BENT. THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BURNT/BLACKENED. THE BROKEN SECTION OF THE EXPOSED CUTTING WIRE HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE AND THE OTHER BROKEN SECTION OF THE EXPOSED CUT WIRE WAS ATTACHED TO THE ANCHOR AT THE DISTAL PIERCE HOLE. THE OUTER DIAMETER (OD) OF THE EXPOSED CUT WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUT WIRE WAS BROKEN. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE BROKEN CUT WIRE 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 RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE SPHINCTEROTOMY, IT WAS NOTED THAT THE CUT WIRE WAS DETACHED FROM THE PROXIMAL END; THE CUT WIRE REMAINED AFFIXED AT THE DISTAL END AND NOTHING DETACHED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND A BALLOON (MANUFACTURER UNKNOWN) WAS THEN USED TO SWEEP THE COMMON BILE DUCT FOR STONE REMOVAL. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE SPHINCEROTOMY, IT WAS NOTED THAT THE CUT WIRE WAS DETACHED FROM THE PROXIMAL END; THE CUT WIRE REMAINED AFFIXED AT THE DISTAL END AND NOTHING DETACHED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND A BALLOON (MANUFACTURER UNKNOWN) WAS THEN USED TO SWEEP THE COMMON BILE DUCT FOR STONE REMOVAL. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    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 14266174

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR