BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS MODERATE SUPPORT GUIDEWIRE

    MDR report key: 671026 · Received February 1, 2006

    Report

    Report Number
    3003778388-2006-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2006
    Date of Event
    January 6, 2006
    Report Date
    February 1, 2006
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR PERFORMED A CARDIAC RESYNCHRONIZATION THERAPY PROCEDURE ON A PT NEEDING A LEFT VENTRICULAR (LV) REPOSITION THAT WAS FIRST DONE BACK IN 2005. THE MEDTRONIC LV LEAD HAD SLIPPED INTO THE COMMON CORONARY SINUS AND HAD TO BE ADVANCED BACK INTO A VESSEL BRANCH. HE PLACED THE SHEATH INTO THE CORONARY SINUS AND ATTEMPTED TO USE THE SAME UNIPOLAR 4193 LV BIVENTRICULAR LEAD WITH A CRONUS MODERATE SUPPORT WIRE TO DELIVER THE LEAD. AFTER TESTING SEVERAL POSITIONS IN SEVERAL VESSELS, HE DECIDED TO WIRE THE POSTERIOR DOWN TO THE APEX THEN BACK UP A LATERAL. THE WIRE LOST ITS TIP UPON PULLING BACK AND WAS VISIBLE ON FLUORO. THE TIP OF THE WIRE WAS LEFT IN THE PT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS MODERATE SUPPORT GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001457-1 0509-4178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN