BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS CS GUIDEWIRE

    MDR report key: 615985 · Received June 2, 2005

    Report

    Report Number
    3003778388-2005-00004
    Event Type
    Malfunction
    Date Received
    June 2, 2005
    Date of Event
    May 12, 2005
    Report Date
    June 2, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN RETRACTED THE GUIDE WIRE BEFORE REDUCING THE MAGNETIC FIELD USING THE NIOBE MAGNETIC NAVIGATION SYSTEM. THE CRONUS CS GUIDEWIRE MAGNET SHEARED OFF OF THE WIRE. THIS OCCURRED DURING A BI-VENTRICULAR PACING PROCEDURE. THE WIRE WAS IN THE CORONARY SINUS WHEN THIS OCCURRED. THE MAGNET PIECE REMAINS IN THE VASCULATURE. THE PHYSICIAN IS NOT CONCERNED AND BELIEVES THERE WILL BE NO COMPLICATIONS FROM THIS INCIDENT. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS CS GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001470-1 0503-4132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention