BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1032613 · Received April 22, 2008

    Report

    Report Number
    3005099803-2008-00368
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVAL. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDERMINED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. THE FEBRUARY 2008 15-MONTH JAGTOME RX 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

    A HYDRATOME RX SPHINCTEROTOME WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, "...THE CUT WIRE BROKE DURING [A] SPHINCTEROTOMY." THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PT'S CONDITION WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11507492

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK