BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRONUS ENDOVASCULAR FLOPPY GUIDEWIRE

    MDR report key: 506590 · Received January 13, 2004

    Report

    Report Number
    3003778388-2003-00004
    Event Type
    Other
    Date Received
    January 13, 2004
    Date of Event
    December 12, 2003
    Report Date
    December 16, 2003
    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

    IT WAS REPORTED DURING A CORONARY ARTERY TREATMENT PROCEDURE A STERIOTAXIS CRONUS FLOPPY GUIDEWIRE WAS ADVANCED DOWN THE RIGHT CORONARY ARTERY TO A LESION BEYOND A BIFURCATION. THE WIRE WAS ANCHORED BEYOND THE LESION. THE LESION WAS THEN BALLOONED AND STENTED. THEN, THE WIRE WAS PULLED PROXIMAL TO THE BIFURCATION AND DIRECTED DOWN A SECONDARY BRANCH, A BYPASS GRAFT. THE WIRE WAS WITHDRAWN AND THEN ADVANCED SEVERAL TIMES AROUND THE BIFURCATION TURN. DURING THE PROCESS OF MAKING THIS REPEATED TURN, THE WIRE TIP WAS PROLAPSED SEVERAL TIMES BY RUNNING INTO THE AFORE MENTIONED STENT. THE WIRE WAS THEN RE-ADVANCED DISTALLY THROUGH THE RECENTLY IMPLANTED STENT, BUT UPON REMOVAL THE WIRE BECAME 'HUNG UP' ON THE INTERSTICES OF THE STENT. REMOVAL OF THE WIRE WAS UNSUCCESSFULLY ATTEMPTED BY VARIOUS APPROACHES FOR APPROX 2.5 HRS BEFORE REMOVAL BY THE FEMORAL APPROACH WAS ABANDONED. THE PT WAS TAKEN TO SURGERY AND THE WIRE WAS REMOVED BY OPENING THE CHEST, DETACHING THE GRAFT, AND UNHOOKING THE CRIMPED WIRE FROM THE STENT. THE GRAFT WAS REATTACHED AND THE PT CLOSED. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR FLOPPY GUIDEWIRE CORONARY GUIDEWIRE DQX STEREOTAXIS, INC. 001-001232-4 0308-4057

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention