BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1133486 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03663
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE HAS BEEN RECEIVED FOR EVAL, THE ANALYSIS HAS NOT BEEN COMPLETED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008, 15-MONTH JAGTOME SPHINCTEROTOME PRODUCT FAMILY 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 TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ONE DAY PRIOR. ACCORDING TO THE COMPLAINANT, WHEN THE TECHNICIAN TRIED TO BOW THE SPHINCTEROTOME, "THE WIRE BROKE ON THE TOME." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11789212

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK