BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 17825864 · Received September 27, 2023

    Report

    Report Number
    0001625425-2023-01206
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DTK
    UDI-DI
    00886333222346
    PMA / PMN Number
    K143405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE PRODUCT EXPERIENCE REPORT, THERE WAS NO SAMPLE TO BE RETURNED. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THIS COMPLAINT COULD NOT BE CONFIRMED AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    100CM SHEATH WOULD NOT ADVANCE, GOT STUCK IN SFV, THEN SHEARED APART WHEN IT WAS REMOVED. SURGEON HAD TO CUT DOWN TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973998 OPTION ELITE RETRIEVABLE VENA CAVA FILTER OPTION ELITE DTK ARGON MEDICAL DEVICES 352506100E 11444018 00886333222346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention