BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRONUS FLOPPY GUIDEWIRE

    MDR report key: 514044 · Received February 23, 2004

    Report

    Report Number
    MW1031300
    Event Type
    Injury
    Date Received
    February 23, 2004
    Date of Event
    December 12, 2003
    Report Date
    February 19, 2004
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STEREOTAXIS GUIDEWIRE LOCKED IN STENT STRUT DURING PTCA. PT REQUIRED SURGERY FOR REMOVAL OF WIRE. PT DISMISSED TO HOME FIVE DAYS LATER. GUIDE WIRE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND DAMAGE TO THE PLATINUM COIL AND DISTAL CUP OF THE WIRE WAS FOUND. STEREOTAXIS DID SAY THE DAMAGE MAY HAVE BEEN CAUSED BY PROLAPSE OF THE WIRE, INTERACTION WITH THE METAL STRUTS OF THE STENT AND POSSIBLY DURING GUIDE CATHETER AND MAGNETIC FIELD MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS FLOPPY GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. * 0308-4057

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention