BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1230421 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06160
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE PROCEDURE. REFER TO MFR REPORTS # 3005099803-2008-06159 FOR DETAILS REGARDING THE FIRST DEVICE. ACCORDING TO THE COMPLAINT, THE SPHINCTEROTOMY COULD NOT BE COMPLETED WITH THE AUTOTOME RX SPHINCTEROTOME DEVICE DUE TO THE INABILITY TO BOW THE DISTAL SEGMENT OF THE CATHETER. REPORTEDLY, THE SPHINCTEROTOME WAS REMOVED AND REPLACED WITH ANOTHER AUTOTOME RX SPHINCTEROTOME DEVICE. REFER TO MFR REPORT # 3005099803-2008-06161 FOR DETAILS REGARDING THE THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545150 11359863

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK