BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1170645 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04591
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. THE 2008 15-MONTH JAGTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THEY HYDRATOME RX SPHINCTEROTOME IS INCLUDED IN THE JAGTOME PRODUCT FAMILY.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MFR REPORT #3005099803-2008-04592 FOR A DESCRIPTION OF THE SECOND EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) IN 2008, THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO "GET GOOD BOWING FROM THE" HYDRATOME RX SPHINCTEROTOME. THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE WITH A SECOND HYDRATOME RX SPHINCTEROTOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583000 0011746073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK