BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1832607 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03890
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVEALED THAT THE WORKING LENGTH WAS TWISTED/BENT AND THE EXTRUSION AT THE DISTAL PIERCE HOLE WAS MELTED/SPLIT. IN ADDITION, THE BLUE PAINT BAND AT THE DISTAL TIP WAS CHIPPED/PEELED. THE MELTED EXTRUSION, CREATED A TEAR MEASURING APPROXIMATELY 7MM PROXIMALLY FROM THE DISTAL PIERCE HOLE. THIS TEAR ALLOWED THE CUT WIRE WITH THE ATTACHED ANCHOR TO SEPARATE FROM THE DISTAL PIERCE HOLE. THOUGH, THE CUT WIRE WITH ATTACHED ANCHOR SEPARATED FROM THE DISTAL PIERCE HOLE, IT REMAINED ATTACHED AT THE PROXIMAL PIERCE HOLE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT CUT WIRE HAD SEPARATED FROM THE DISTAL TIP. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED FOR WORKING LENGTH AND CUT WIRE INTEGRITY SO THE SEPARATED CUT WIRE WITH ANCHOR, IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 AN AUTOTOME SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AUTOTOME RX SPHINCTEROTOME WAS INSERTED DOWN THE ENDOSCOPE AND POSITIONED AT THE PAPILLA. THE DEVICE WAS BOWED AND ELECTRICALLY ACTIVATED TO PERFORM THE SPHINCTEROTOMY. HOWEVER, DURING THE SPHINCTEROTOMY, THE DEVICE FAILED TO BOW. UNDER ENDOSCOPIC VISUALIZATION, IT WAS DISCOVERED THAT THE CUT WIRE HAD SEPARATED FROM THE DISTAL TIP. THE CUT WIRE DID NOT COMPLETELY DETACH FROM THE DEVICE AS IT REMAINED AFFIXED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AUTOTOME RX SPHINCTEROTOME WAS INSERTED DOWN THE ENDOSCOPE AND POSITIONED AT THE PAPILLA. THE DEVICE WAS BOWED AND ELECTRICALLY ACTIVATED TO PERFORM THE SPHINCTEROTOMY. HOWEVER, DURING THE SPHINCTEROTOMY, THE DEVICE FAILED TO BOW. UNDER ENDOSCOPIC VISUALIZATION, IT WAS DISCOVERED THAT THE CUT WIRE HAD SEPARATED FROM THE DISTAL TIP. THE CUT WIRE DID NOT COMPLETELY DETACH FROM THE DEVICE AS IT REMAINED AFFIXED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170 0013403688

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR