BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG PRECURSOR

    MDR report key: 1265412 · Received December 16, 2008

    Report

    Report Number
    3005099803-2008-07159
    Event Type
    Injury
    Date Received
    December 16, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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, FOREIGN MATERIAL WAS NOTED. THE LESION WAS LOCATED IN AN UNSPECIFIED BILE DUCT. ANOTHER MANUFACTURER'S CANNULA WAS PLACED AND THE 0.035 JAG PRECURSOR GUIDE WIRE WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO REMOVE THE CANNULA, A BLACK FOREIGN MATERIAL CAME OUT OF THE PAPILLA. THE CANNULA AND GUIDE WIRE WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC M0055658011 8521600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OLYMPUS CANNULA| JF-240 ENDOSCOPE