BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIEWFLEX CATHETER, XTRA ICE

    MDR report key: 3459141 · Received October 8, 2013

    Report

    Report Number
    2030404-2013-00076
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    ST. JUDE MEDICA, INC. (AF-IRVINE)
    Product Code
    IYO
    PMA / PMN Number
    K121381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ABLATION PROCEDURE USING A VIEWFLEX XTRA ICE CATHETER, THE TIP OF THE CATHETER WAS FRACTURED. THE VIEWFLEX XTRA ICE CATHETER WAS ADVANCED THROUGH A 10F SHORT INTRODUCER VIA THE LEFT FEMORAL VEIN FOR THE PURPOSE OF VISUALIZING THE RIGHT ATRIAL SEPTUM FOR TRANSSEPTAL ACCESS. AS THE CATHETER EXITED THE SHORT INTRODUCER, THERE WAS SOME DIFFICULTY IN GETTING INTO THE MAIN INFERIOR VENA CAVA TRUNK AS THE CATHETER KEPT TRACKING INTO VARIOUS SIDE BRANCHES. AFTER AN ATTEMPT TO MANIPULATE THE CATHETER INTO THE INFERIOR VENA CAVA, FLUOROSCOPY REVEALED THE DISTAL TIP OF THE CATHETER BENT IN HALF BUT WAS STILL ATTACHED. THE CATHETER WAS REMOVED FROM THE PATIENT AND REPLACED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510465 VIEWFLEX CATHETER, XTRA ICE ICE CATHETER IYO ST. JUDE MEDICA, INC. (AF-IRVINE) D087031 4176490

    Patients

    Seq Age Sex Outcome Treatment
    1 10 FR SHORT INTRODUCER (MODEL/LOT UNKNOWN)