BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS MODERATE SUPPORT GUIDEWIRE

    MDR report key: 660854 · Received January 4, 2006

    Report

    Report Number
    3003778388-2005-00011
    Event Type
    Malfunction
    Date Received
    January 4, 2006
    Date of Event
    November 30, 2005
    Report Date
    December 28, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR PLACED THE WIRE AND IT TOOK THREE TIMES TO ADVANCE THE LEAD OVER THE MODERATE SUPPORT WIRE. THE BI-POLAR MEDTRONIC LEAD WAS NOT PROPERLY POSITIONED IN THE POSTERIOR LATERAL BRANCH. BECAUSE THE WIRE WAS DAMAGED AND HE HAD A KNOT IN THE TIP, HE EXCHANGED THE WIRE. WHILE ADVANCING THE LEAD OVER THE SECOND WIRE IT SUDDENLY POPPED IN THE CULPRIT VEIN. THE TIP OF THE WIRE WAS CAUGHT BETWEEN THE OUTSIDE OF THE LEAD AND THE INSIDE OF THE VEIN. HE TRIED TO REMOVE THE WIRE WHILE APPLYING MODERATE FORCE AND THIS BROKE OFF THE MAGNETIC TIP OF THE WIRE. USING A SECOND WIRE THE WIRE TIP WAS RETRIEVED. ONCE THE LEAD WAS REMOVED A UNIPOLAR LEAD WAS INSERTED OVER THE THIRD CRONUS MODERATE SUPPORT WIRE USING THE STORED NAVIGATION FROM THE FIRST PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS MODERATE SUPPORT GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001457-1 0504-4161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN