BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPORT AP

    MDR report key: 2243393 · Received August 18, 2011

    Report

    Report Number
    1220452-2011-00061
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXE
    PMA / PMN Number
    K081573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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.

    Description of Event or Problem · 1

    MEDWATCH REPORT NUMBER FROM HOSPITAL (B)(4). IT WAS REPORTED TO US THAT DURING A RIGHT POSTERIOR TIBIA PTA, A 6F EXPORT CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT GROIN AND DOWN INTO THE LEG. UPON REMOVAL OF THE EXPORT, IT WAS NOTED THAT THE END OF THE CATHETER WAS MISSING. A 4MM MICRO SNARE DEVICE WAS INSERTED AND SUCCESSFULLY RETRIEVED THE END OF THE EXPORT CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPORT AP DXE MEDTRONIC, INC. NA 0005650609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention