BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS ENDOVASCULAR FLOPPY

    MDR report key: 592636 · Received April 11, 2005

    Report

    Report Number
    3003778388-2005-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2005
    Date of Event
    March 15, 2005
    Report Date
    April 8, 2005
    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

    WIRE WAS IN PLACE IN RCA BUT COULDN'T ADVANCE STENT OVER WIRE. BALLOONS WOULD NOT PASS OVER WIRE THROUGH LESION. THE CRONUS WAS LEFT IN THE PATIENT'S "TRUE LUMEN" WHILE CONVENTIONAL GUIDE WIRES WERE USED. A DISSECTION OCCURRED IN THE RCA. STENTS WERE PLACED ALONG 50MM OF THE RCA LUMEN. THE CRONUS WIRE WAS STENTED OVER AND PINNED AGAINST THE LUMEN WALL. THE DECISION WAS MADE TO REMOVE THE CRONUS AND WAS DONE SUCCESSFULLY. THE WIRE STAYED INTACT. THE STENTING WAS PERFORMED SUCCESSFULLY. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR FLOPPY GUIDEWIRE DQX STEREOTAXIS, INC. 001-001232-3 0502-4122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention IN 03/2005, USING A GUIDEWIRE AND ANGIOPLASTY| STENTS WERE IMPLANTED (UNKNOWN MANUFACTURER) IN| BALLOON.