BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1230420 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06159
    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). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SPHINCTEROTOMY COULD NOT BE COMPLETED WITH THE HYDRATOME RX SPHINCTEROTOME DEVICE DUE TO THE INABILITY TO BOW THE DISTAL SEGMENT OF THE CATHETER. REPORTEDLY, THE SPHINCTEROTOME WAS REMOVED AND REPLACED WITH AN AUTOTOME RX SPHINCTEROTOME DEVICE. REFER TO MFR REPORT # 3005099803-2008-06160 FOR DETAILS REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583000 11962615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK