BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 10605517 · Received September 30, 2020

    Report

    Report Number
    10605517
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    February 12, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO DEPLOY ARGON MEDICAL DEVICES, INC. OPTION ELITE RETRIEVABLE VENA CAVA FILTER LODGED IN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069579 OPTION ELITE RETRIEVABLE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK ARGON MEDICAL DEVICES, INC. 352506070E 11279012

    Patients

    Seq Age Sex Outcome Treatment
    1