BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRONUS ENDOVASCULAR FLOPPY

    MDR report key: 619381 · Received June 30, 2005

    Report

    Report Number
    3003778388-2005-00006
    Event Type
    Death
    Date Received
    June 30, 2005
    Date of Event
    June 3, 2005
    Report Date
    June 30, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR TREATED A PT. THE MAGNETIC TARGET LESION WAS IN THE CIRCUMFLEX AND WAS INITIALLY SUCCESSFULLY TREATED. THE OPERATOR SAW SOME PROXIMAL NARROWING IN THE PROXIMAL PART OF THE CIRCUMFLEX THAT BECAME EVIDENT AFTER THE DISTAL SUCCESSFUL STENTING. WHILE PUSHING THE SECOND STENT INTO THE CIRCUMFLEX THE OPERATOR HAD TO DEEP SEED THE JL4 GUIDING CATHETER COVERING THE LATTER PART OF THE LEFT MAIN CORONARY ARTERY. WHILE PUSHING AND PUSHING HE BECAME AWARE OF THE FACT THAT, HAVING THE DISTAL PART OF THE STENT IN THE CIRCUMFLEX, HE WAS PUSHING THE FIRST ONE THIRD OF THE STENT IN THE LAD. THIS LED TO A DISSECTION OF THE LAD BACK TO THE MAIN. ALL AREAS WERE SUCCESSFULLY STENTED. THE OPERATOR IS CONVINCED THAT IT IS NOT THE WIRE THAT LED TO WHAT HAPPENED BUT HIS PUSHING MORE LIKELY CAUSED THE DISSECTION. THE PT LEFT THE CATH LAB IN STABLE CONDITION. THE PT EXPIRED 48 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR FLOPPY GUIDEWIRE DQX STEREOTAXIS, INC. 001-001232-3 0409-4111

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death