BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPORT XT

    MDR report key: 1051194 · Received May 22, 2008

    Report

    Report Number
    1220452-2008-00042
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXE
    PMA / PMN Number
    K061958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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.

    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 PHYSICIAN INSERTED A GUIDE WIRE INTO THE PATIENT'S RIGHT CORONARY ARTERY. THE PHYSICIAN INSERTED THE ASPIRATION CATHETER OVER THE GUIDE WIRE AND ADVANCED IT FORWARD INTO THE RIGHT CORONARY ARTERY. THE PHYSICIAN STARTED ASPIRATION OF THE ARTERY; HOWEVER SUCTIONING BLOOD ONLY WITH NO THROMBUS. THE PHYSICIAN REMOVED THE ASPIRATION CATHETER FOR INSPECTION AND NOTICED THAT THE WIRE LUMEN OF THE ASPIRATION CATHETER WAS TORN. THE PHYSICIAN INSERTED ANOTHER DEVICE AND COMPLETED THE CASE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPORT XT DXE MEDTRONIC INC. NA 0000573370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA