BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEANER ROTATIONAL THROMBECTOMY SYSTEM

    MDR report key: 4278662 · Received November 21, 2014

    Report

    Report Number
    4278662
    Event Type
    Death
    Date Received
    November 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    November 21, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING DE-CLOT/THROMBECTOMY OF ARTERIAL VENOUS FISTULA. THE CLEANER DEVICE WAS SUCCESSFULLY USED TO MACERATE CLOT AT VENOUS LEVEL. IMMEDIATELY FOLLOWING THE PROCEDURE, SYMPTOMS OF A STROKE NOTED. PATIENT DIAGNOSIS CONFIRMED. INTERVENTION PERFORMED. CEREBRAL EDEMA; SEVERE COMPRESSION. PATIENT EXPIRED FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757652 CLEANER ROTATIONAL THROMBECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW ARGON MEDICAL DEVICES INC. 70015 REF1400231

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death