BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRONUS ENDOVASCULAR GUIDEWIRE

    MDR report key: 539351 · Received August 10, 2004

    Report

    Report Number
    3003778388-2004-00002
    Event Type
    Other
    Date Received
    August 10, 2004
    Report Date
    July 15, 2004
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ANGIOPLASTY PROCEDURE, THE CRONUS INTERMEDIATE GUIDE WIRE STUCK TO THE INSIDE OF AN ANGIOPLASTY BALLOON AFTER CROSSING A LESION. THE SYSTEM HAD TO BE REMOVED FROM THE PT. TWO SEPARATE LESIONS HAD PREVIOUSLY BEEN CROSSED WITH SAME SYSTEM. THE THIRD LESION WAS CROSSED ONCE, AND THE WIRE RETRACTED BACK INTO THE BALLOON CATHETER. FURTHER ATTEMPTS TO CROSS THE THIRD LESION WERE UNSUCCESSFUL AS THE WIRE KEPT RETRACTING. THE AMOUNT OF TIME USED TO CROSS THE LESION WAS GREATER THAN TWENTY MINUTES. AS THE BALLOON CATHETER WAS WITHDRAWN FROM THE PT, THE WIRE STUCK TO THE SIDES OF THE BALLOON CATHETER. THE WIRE COULD NOT BE REMOVED FROM THE PT. ANOTHER COMPANY'S WIRE WAS THEN USED AND A DISSSECTION OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE THIRD LESION AGAIN. THE PT WAS REFERRED TO EMERGENCY GRAFT SURGERY AND IS DOING WELL. THE CRONUS WIRE WAS IN THE MID-CIRCUMFLEX AND THE DISSECTION STARTED PRIOR TO THE FIRST OBTUSE MARGINAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001096-4 0403-4086

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other