BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 15629365 · Received October 18, 2022

    Report

    Report Number
    15629365
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    June 28, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DTK
    UDI-DI
    00886333217151
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SHEATH HUB ON FILTER CATHETER BROKE, NO HARM TO PATIENT OR STAFF. MANUFACTURER RESPONSE FOR FILTER, INTRAVASCULAR, CARDIOVASCULAR, OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM (PER SITE REPORTER). RECORDED PRODUCT, ISSUED RGA# (B)(4), SENT SHIPPING LABEL TRK# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2932518 OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK ARGON MEDICAL DEVICES, INC. 352506070E 11404367 00886333217151

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA Male