BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPORT XT

    MDR report key: 1111951 · Received August 11, 2008

    Report

    Report Number
    1220452-2008-00058
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXE
    PMA / PMN Number
    K061958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE WIRE LUMEN OF THE ASPIRATION CATHETER BECAME TORN. THE PT HAS A VERY TORTUOUS AND CALCIFIED VESSEL. THE PHYSICIAN INSERTED THE ASPIRATION CATHETER OVER THE GUIDE WIRE INTO THE PT; HOWEVER, EXPERIENCED DIFFICULTY ADVANCING THE ASPIRATION CATHETER. THE PHYSICIAN PULLED BACK ON THE ASPIRATION CATHETER AND THE WIRE LUMEN OF THE ASPIRATION CATHETER BECAME TORN. UPON INSPECTION OF THE ASPIRATION CATHETER, THE RADIOPAQUE MARKER BAND WAS STILL ATTACHED TO THE DISTAL TIP OF THE CATHETER. THE DEVICE WAS REPLACED WITH ANOTHER TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPORT XT DXE MEDTRONIC, INC. NA 0000766851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA