BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG PRECURSOR

    MDR report key: 1244505 · Received November 26, 2008

    Report

    Report Number
    3005099803-2008-06854
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    October 25, 2008
    Report Date
    October 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Adverse Event
    Yes
    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 JAG PRECURSOR GUIDE WIRE FRACTURED IN THE PATIENT. THE WIRE WAS INSERTED INTO THE CANNULA AND AN ATTEMPT WAS MADE TO ADVANCE THE WIRE THROUGH THE LEFT HEPATIC DUCT. THE DISTAL PORTION OF THE WIRE BROKE AND MIGRATED INTO THE BILE DUCT. THE WIRE PORTION WAS REMOVED FROM THE PATIENT'S BODY USING A BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A HYDRAJAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055658011 11902236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS CANNULA