BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 934623 · Received April 10, 2007

    Report

    Report Number
    6000123-2007-00016
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    March 15, 2007
    Report Date
    March 16, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    na
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. THE PRODUCT HAS BEEN RECEIVED BY THE MFR, BUT AN EVALUATION HAS NOT YET BEEN CONDUCTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND IT HAS BEEN DETERMINED THAT THE REPORTED LOT MET ALL SPECS AND HAD NO ANOMALIES RELEVANT TO THE REPORTED COMPLAINT UPON ITS RELEASE. THE REPORTED LOT HAS NOT BEEN INVOLVED IN PREVIOUS COMPLAINTS. FURTHER, THE FEBRUARY 2007 15 MONTH TREND CHART FOR THE JAGWIRE PRODUCT FAMILY WAS REVIEWED AND INDICATED NO ADVERSE TRENDS FOR THE PRODUCT FAMILY. ADDITIONALLY, THE COMPLAINT ALERT LIMIT WAS NOT EXCEEDED. BECAUSE THE EVALUATION HAS NOT YET BEEN COMPLETED, WE ARE UNABLE TO REPORT A ROOT CAUSE FOR NEITHER THE REPORTED FAILURE MODE NOR THE RELATIONSHIP BETWEEN IT AND THE CAUSE FOR THE EVENT. RESULTS OF DEVICE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PT (AGE AND GENDER UNK) UNDERWENT A PROCEDURE INVOLVING THE USE OF A BSC JAG PRECURSOR DEVICE. REPORTEDLY, THE "DEVICE WAS INSERTED INTO THE TANDEM CANNULA AND WAS PLACED. THEN THE MAXFORCE WAS USED TO (COMPLETE) THIS PROCEDURE. IT WAS FOUND THAT A PEBAX COATING WAS DETACHED INSIDE THE RIGHT INTRAHEPATIC BILE DUCT." ALSO, "THE PHYSICIAN TRIED TO REMOVE IT BUT IT WAS NOT POSSIBLE. THE PHYSICIAN DECIDED TO LEAVE THIS DETACHMENT. IT WAS THOUGHT THAT THE DETACHMENT WOULD BE ELIMINATED NATURALLY. THIS PROCEDURE WAS COMPLETED USING THIS DEVICE." NO SERIOUS INJURY OR FURTHER COMPLICATIONS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZS EZB BOSTON SCIENTIFIC M0055660011 8258937

    Patients

    Seq Age Sex Outcome Treatment
    1 YR