BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG PRECURSOR

    MDR report key: 1221232 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-05951
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 3005099803-2008-06053. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE COATING PEELED FROM TWO JAG PRECURSOR GUIDE WIRES. DURING THE PROCEDURE, THE PHYSICIAN USED THE FIRST JAG PRECURSOR AND THE COATING PEELED. ANOTHER JAG PRECURSOR WAS THEN USED AND ALSO PEELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PEELED COATING WAS REMOVED AT THE SAME TIME AS THE STONE IN THE BILIARY DUCT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE "STABLE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM- GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055658011 11643002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other