BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPINCTEROTOME

    MDR report key: 2153309 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02087
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS REPORTED FOR THE SAME LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED; NO ANOMALIES WERE NOTED. THE (B)(6) 2008, 15-MONTH JAGTOME 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 WITH THE JAGTOME PRODUCT FAMILY FOR COMPLAINT TRENDING PURPOSES. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO REPORTED MALFUNCTIONS OCCURRING DURING THE SAME PROCEDURE. A HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, "WHILE TRYING TO CANNULATE THE COMMON BILE DUCT, THE DISTAL END OF THE SPHINCTEROTOME BECAME TWISTED UPON ITSELF AND COULD NOT BE USED." NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AN AUTOTOME RX SPHINCTEROTOME DEVICE WAS SELECTED TO REPLACE THE HYDRATOME SPHINCTEROTOME. REFER TO MFR REPORT #3005099803-2008-02059 FOR DETAILS REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11622702

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR