BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 918665 · Received March 28, 2007

    Report

    Report Number
    6000123-2007-00013
    Event Type
    Malfunction
    Date Received
    March 28, 2007
    Date of Event
    February 28, 2007
    Report Date
    February 28, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPECIFICATIONS, 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

    THE COMPLAINANT HAS REPORTED THAT A PT (AGE AND GENDER UNK) UNDERWENT AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE. THE PROCEDURE INVOLVED THE USE OF A BSC JAG PRECURSOR GUIDEWIRE DEVICE. IT WAS REPORTED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY "THE GUIDEWIRE WAS INSERTED INTO THE TARGET SITE WITH THE CANNULA (OLYMPUS, SWING TIP). IT WAS NOTED THAT THERE WAS A STRONG ANGLE IN THE BILE DUCT. WHEN THE GW WAS HANDLED, THE PEBAX COATING DETACHED INTO THE SYSTIC DUCT." THE DETACHMENT WAS LEFT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE. THE PT SUFFERED NO ILL EFFECTS OR COMPLICATIONS AS A RESULT OF THIS EVENT AND WAS REPORTED TO BE IN "STABLE" CONDITION FOLLOWING THE COMPLETION OF THE PROCEDURE. IT WAS NOTED THAT "THE DOCTOR THOUGHT THAT THE DETACHMENT WAS NOT AN ADVERSE EFFECT TO THE PATIENT". MOREOVER, THE DEVICE WAS USED BEYOND THE DATE OF ITS "EXPECTED LIFE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZB EZB BOSTON SCIENTIFIC M0055660011 5382005

    Patients

    Seq Age Sex Outcome Treatment
    1 YR