BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC D

    MDR report key: 1052546 · Received May 22, 2008

    Report

    Report Number
    2242445-2008-00018
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 BY THE PHYSICIAN THAT THE PROCEDURE WAS BEING PERFORMED ON A RIGHT ARM GRAFT OF A MALE PT. THE CATHETER WAS BEING USED FOR A DECLOT PROCEDURE WHEN TWO OF THE WIRES SEPARATED FROM THE TIP OF THE DEVICE. AS A RESULT, THE PERCUTANEOUS THROMBOLYTIC DEVICE (PTD) WAS REMOVED AND ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC D PTD PRODUCTS DXE ARROW INTERNATIONAL INC MF8039959

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention