BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1102014 · Received August 7, 2008

    Report

    Report Number
    3005099803-2008-01485
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL; THEREFORE, A DEVICE ANALYSIS IS NOT AVAILABLE. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008 15-MONTH JAGTOME PRODUCT FAMILY COMPLAINT TREND, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. HYDRATOME RX SPHINCTEROTOME DEVICES ARE INCLUDED IN THE JAGTOME PRODUCT FAMILY.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT 3005099803-2008-01480 FOR A DESCRIPTION OF THE SECOND EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A HYDRATOME RX WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN A (PT AGE, GENDER AND WEIGHT UNKNOWN) FOUR DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE DEVICE HAD A DAMAGED TIP WHEN REMOVED FROM THE PACKAGE. THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE WITH A SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME FDI BOSTON SCIENTIFIC CORPORATION M00583060 0011778917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK