BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1061609 · Received June 17, 2008

    Report

    Report Number
    3005099803-2008-00734
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED. THE MARCH 2008 15-MONTH JAGTOME SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THE HYDRATOME RX SPHINCTEROTOME PRODUCT FAMILY IS INCLUDED IN THE SAME TREND REPORT AS THE JAGTOME PRODUCT FAMILY.

    Description of Event or Problem · 1

    DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)- SPHINCTEROTOMY PROCEDURE, THE CUTWIRE OF HYDRATOME RX SPHINCTEROTOME BROKE. THE PHYSICIAN REMOVED THE DEVICE AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE WITH NO COMPLICATIONS. THE PT CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11643340

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR