BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1150238 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04264
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 10, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF LOT NUMBER WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. THE DEVICE IS NOT AVAILABLE FOR THE EVAL. THE CAUSE OF THE EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILIARY SYSTEM, AN AUTOTOME RX SPHINCTEROTOME WAS USED. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE CUTTING WIRE BROKE WHILE INSIDE THE PT. THE CUTTING WIRE BROKE WHEN THE DR WAS CUTTING THE AMPULLA. THE DEVICE WAS SUBSTITUTED BY ANOTHER DEVICE. THE PT'S CONDITION IS REPORTED TO BE STABLE. THE DEVICE LOCATION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545180 9489045

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other