BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 1238462 · Received November 13, 2008

    Report

    Report Number
    3005099803-2008-06486
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE GUIDE WIRE BECAME STUCK IN A STENT DELIVERY SYSTEM. THE PHYSICIAN RELEASED AN UNSPECIFIED STENT IN THE LEFT HEPATIC DUCT. FOLLOWING RELEASE OF THE STENT, THE GUIDE WIRE BECAME STUCK IN THE DELIVERY SYSTEM. THE ENTIRE SYSTEM WAS REMOVED AS A UNIT WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "GOOD" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055659011 11795612

    Patients

    Seq Age Sex Outcome Treatment
    1