BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 7181843 · Received January 11, 2018

    Report

    Report Number
    7181843
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 12, 2017
    Report Date
    December 27, 2017
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS WE PLACED AN IVC FILTER, AN UNKNOWN PIECE OF NYLON TYPE STRING WAS FOUND APPEARING TO COME OUT OF THE FILTER SHEATH. WE PLACED THE STRING MATERIAL ON THE BACK TABLE AND CONTINUED ON WITH THE EXAM. WE PLACED THE MATERIAL IN A BAG TO KEEP, AND CONTACTED THE REP OF THE COMPANY TO SEE IF THEY CAN IDENTIFY THE SOURCE OF THE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26136 OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK ARGON MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR