BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRONUS MODERATE SUPPORT GUIDEWIRE

    MDR report key: 617061 · Received June 23, 2005

    Report

    Report Number
    3003778388-2005-00005
    Event Type
    Injury
    Date Received
    June 23, 2005
    Date of Event
    May 25, 2005
    Report Date
    May 25, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CASE PROCEEDED WELL WITH AN ASSERT WIRE AND THEN A CRONUS MS WIRE PLACED IN THE RIGHT CORONARY ARTERY UTILIZING THE NIOBE NAVIGATION SYSTEM. A BALLOON WAS PLACED TO THE LESION AND A CONVENTIONAL WIRE WAS PLACED, AND FLUORO CEASED TO FUNCTION (THE NIOBE MNS HAD BEEN STOWED). THE RADIOGRAPHER SAID THAT THERE WAS A "BLACK DOT" ON THE BOTH SIEMENS X-RAY MONITORS WITH AN ERROR MESSAGE STATING SOMETHING LIKE "CAN NOT PROCEED. MUST STORE FLUORO". THE "STORE FLUORO" BUTTON ON THE TOUCH PAD WAS GRAYED AND NOT SELECTABLE. AN ERROR MESSAGE ALSO APPEARED ON NIOBE (PROCEDURE AND CONTROL ROOMS) "USB MASS STORAGE DEVICE CANNOT BE REMOVED". ULTIMATELY THE SIEMENS SYSTEM WAS REBOTTED WHICH ELIMINATED ALL OF THE ERROR MESSAGES AND RESTORED FLUORO. WHEN ABLE TO FLUORO THERE WAS A LARGE DISSECTION IN THE RIGHT CORONARY ARTERY ULTIMATELY REQUIRING THAT THE PT BE TAKEN TO THE OR FOR EMERGENT OPEN HEART SURGERY. THE PT SUCCESSFULLY RECEIVED A SINGLE CABG AND WAS RELEASED FROM THE CCU IN 2005 DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS MODERATE SUPPORT GUIDEWIRE CORONARY GUIDEWIRE DQX STEREOTAXIS, INC. 011-001457-2 0412-4117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R