BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1220122 · Received October 31, 2008

    Report

    Report Number
    3005099803-2008-05752
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT THE SUSPECT DEVICE WAS DISPOSED. THE PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE COMPLAINT IS NOT CONFIRMED AS THE SUSPECT DEVICE WAS NOT AVAILABLE FOR THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE OF THE BILIARY DUCT THE CAUTERY WOULD NOT WORK WITH THE HYDROTOME RX SPHINCTEROTOME. THE TOME WOULD NOT CUT. THE PHYSICIAN MADE ONE ADDITIONAL ATTEMPTS WITH ONE OTHER SIMILAR DEVICES AND EXPERIENCED THE SAME ISSUE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE FINE. REFER TO ASSOCIATED MANUFACTURER REPORT# 3005099803-2008-05755 FOR THE REPORT ON THE OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583050 12008785

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK