BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG PRECURSOR

    MDR report key: 1273067 · Received December 22, 2008

    Report

    Report Number
    3005099803-2008-07341
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 27, 2008
    Report Date
    November 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    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 A BILIARY STENTING PROCEDURE, RESISTANCE WAS ENCOUNTERED AND A GUIDE WIRE COATING DETACHMENT OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED STENTING PROCEDURE. THE 0.035 JAG PRECURSOR GUIDE WIRE WAS ADVANCED PLACED AND ANOTHER MANUFACTURER'S 5FR PLASTIC STENT WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO REMOVE THE GUIDE WIRE IN PREPARATION FOR STENT DEPLOYMENT, THE BLACK COATING ON THE DISTAL TIP OF THE GUIDE WIRE DETACHED AND REMAINED INSIDE THE BILE DUCT. THE PHYSICIAN ATTEMPTED TO REMOVE THE COATING BY UNSPECIFIED MEANS BUT WAS UNSUCCESSFUL. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS REPORTED AS "NO PROBLEM". IT WAS THE PHYSICIAN'S OPINION THAT THE COATING DAMAGE OCCURRED AS A RESULT OF RESISTANCE ENCOUNTERED DURING MOVEMENT BETWEEN THE GUIDE WIRE AND STENT, DUE TO THE SHAPE OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM-GUIDEWIRE EZB BOSTON SCIENTIFIC M0055658011 8548517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COOK 5FR DOUBLE PIG PLASTIC STENT