BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 1063459 · Received June 20, 2008

    Report

    Report Number
    2242445-2008-00024
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VERY EXPERIENCED PHYSICIAN WAS USING THE DEVICE AND A .025 NITREX WIRE IN A GRAFT. HE DESCRIBED THE VESSEL TO BE TORTUOUS, BUT NOT EXTREMELY. THE DEVICE WAS IN THE BRACHIAL ARTERY; HOWEVER, IT COULD NOT GET PAST THE STENOSIS. THE TIP OF THE CATHETER BROKE OFF. AS A RESULT, A SNARE WAS USED BY THE PHYSICIAN TO REMOVE THE TIP. FURTHER DETAILS ARE BEING PURSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTERNATIONAL INC MF7128319

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention