BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 938659 · Received April 13, 2007

    Report

    Report Number
    6000123-2007-00017
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 21, 2007
    Report Date
    March 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    na
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS 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 THIS DEVICE HISTORY RECORD REVIEW WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT. THE FEBRUARY 2007 15-MONTH TREND REPORT FOR THIS PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007, THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ON A MALE USING A JAG PRECURSOR GUIDEWIRE DEVICE, "THE HYDROPHILIC TIP PEELED OFF". THE PHYSICIAN HAD PASSED THE GUIDEWIRE INTO THE SPHINCTEROTOME AND WAS TRYING TO "NEGOTIATE INTO THE STRICTURE (WHEN) THE HYDROPHILIC TIP PEELED OFF". THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY USING A DIFFERENT DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO FIND OUT IF THE TIP HAD BEEN RECEIVED TO NO AVAIL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZB EZB BOSTON SCIENTIFIC M00055658011 8935009

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR