BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPINCTEROTOME

    MDR report key: 1191158 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04896
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MFR AND EXPIRATION DATES CANNOT BE DETERMINED. A REVIEW OF THE HISTORY RECORD COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED IN THE COMPLAINT. THE DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS, THE CUSTOMER HAS DISPOSED OF THE DEVICE. BASED ON THE EVAL OF OTHER DEVICES WITH THE SAME COMPLAINT (CANNULATING ORIENTATION), THE MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED WITHOUT EVALUATING THE DEVICE, SINCE THIS COULD BE DUE TO USER HANDLING, DEVICE DESIGN OR MFG/PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), THE AUTOTOME RX SPHINCTEROTOME WAS NOT ORIENTED CORRECTLY. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT IS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545170 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR