BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 963880 · Received May 10, 2007

    Report

    Report Number
    6000123-2007-00020
    Event Type
    Malfunction
    Date Received
    May 10, 2007
    Date of Event
    April 17, 2007
    Report Date
    April 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MFR. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE A FAILURE ANALYSIS IN NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. RESULTS OF THE DEVICE HISTORY RECORD REVIEW WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT. THE MARCH 2007 15-MONTH JAGWIRE COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Description of Event or Problem · 1

    ON APRIL 18, 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP, THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING A JAG PRECURSOR ON A MALE, THE "DISTAL 1CM HYDROPHILIC TIP DETACHED". THE PHYSICIAN HAD COMPLETED THE CANNULATION OF THE COMMON BILE DUCT USING THIS DEVICE AND AN UNK SPHINCTEROTOME, WHEN THE TIP DETACHED INTO THE COMMON BILE DUCT. THE PHSICIAN RETRIEVED THE TIP AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZB EZB BOSTON SCIENTIFIC M0055658011 8092987

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR