BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS ENDOVASCULAR FLOPPY GUIDEWIRE

    MDR report key: 528089 · Received February 25, 2004

    Report

    Report Number
    3003778388-2004-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Report Date
    January 27, 2004
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN PERFORMING A BIV LEAD PLACEMENT, THE GUIDEWIRE BECAME STUCK, AND SEPARATED AT THE TIP. THE DEVICE WAS BEING REMOVED FROM A MEDTRONIC BIV LEAD WHEN THE WIRE BECAME STUCK IN THE HEMOSTASIS VALVE. THE DR. STATED "HE PUSHED THE WIRE FORWARD AND PULLED THE WIRE TO REMOVE FROM THE LEAD WHEN THE WIRE SEPARATED." THE TIP REMAINED IN THE HEMOSTASIS VALVE OF THE LEAD. THE LEAD WAS REMOVED FROM THE PATIENT AND ANOTHER MANUFACTURERS WIRE, TOGETHER WITH ANOTHER LEAD, WAS RE-INSERTED AND DEPLOYED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR FLOPPY GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001232-3 0305-4024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention