BEUDAMED
    FDA Adverse Event Death Summary report: N

    JETI PERIPHERAL THROMBECTOMY SYSTEM

    MDR report key: 7839703 · Received August 31, 2018

    Report

    Report Number
    3010127658-2018-00002
    Event Type
    Death
    Date Received
    August 31, 2018
    Date of Event
    August 7, 2018
    Report Date
    August 31, 2018
    Manufacturer
    WALK VASCULAR, LLC
    Product Code
    DXE
    UDI-DI
    B139WV008F0
    PMA / PMN Number
    K172000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE JETI PERIPHERAL THROMBECTOMY SYSTEM IS INTENDED TO REMOVE/ASPIRATE FLUID AND BREAK-UP SOFT EMBOLI AND THROMBUS FROM THE PERIPHERAL VASCULATURE AND TO SUB SELECTIVELY INFUSE/DELIVER DIAGNOSTICS OR THERAPEUTICS WITH OR WITHOUT VESSEL OCCLUSION. THIS PARTICULAR PROCEDURE INVOLVED INTERVENTION INTO THE PULMONARY ARTERIES, WHICH IS NOT AN APPROVED INDICATION FOR THIS DEVICE. THE JETI PERIPHERAL THROMBECTOMY SYSTEM OPERATED AS INTENDED WITH NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    AN ADVERSE EVENT OCCURRED WHILE USING THE JETI PERIPHERAL THROMBECTOMY SYSTEM IN (B)(6), USA. THE PATIENT WAS TREATED FOR PULMONARY EMBOLISM AND CRASHED APPROXIMATELY 10-15 MINUTES INTO THE INTERVENTIONAL PORTION OF THE PROCEDURE. THE PATIENT WAS INTERMITTENTLY RECOVERED SEVERAL TIMES. HOWEVER, THE PATIENT ULTIMATELY EXPIRED WITHIN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678051 JETI PERIPHERAL THROMBECTOMY SYSTEM THROMBECTOMY CATHETER DXE WALK VASCULAR, LLC WV008F 1803027 B139WV008F0

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death