BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 1350380 · Received December 23, 2008

    Report

    Report Number
    3005099803-2008-07368
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    November 27, 2008
    Report Date
    December 4, 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 COATING OF THE JAG PRECURSOR GUIDE WIRE WAS DAMAGED. THE CANNULA WAS ADVANCED THROUGH THE LESION AND THE WIRE WAS INSERTED AND CROSSED TO THE LESION. WHEN THE CANNULA WAS REMOVED, THE CORE WIRE WAS EXPOSED 10CM FROM THE DISTAL END OF THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS AND THE PT'S STATUS WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDE WIRE EZB BOSTON SCIENTIFIC CORPORATION M0055656011

    Patients

    Seq Age Sex Outcome Treatment
    1