BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SNARE OUS

    MDR report key: 23352111 · Received October 21, 2025

    Report

    Report Number
    3008988055-2025-00012
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 21, 2025
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    MMX
    UDI-DI
    00857834006551
    PMA / PMN Number
    K152560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. DEVICE WAS DISCARDED BY USER AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER RETRIEVAL USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE SNARE LOOP ALLEGEDLY GOT CAUGHT ON THE FILTER LEG. IT WAS FURTHER REPORTED THAT A TIP MARKER FELL INTO THE BLOOD VESSEL. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237421 BARD SNARE OUS DEVICE, PERCUTANEOUS RETRIEVAL MMX HERAEUS MEDICAL COMPONENTS LLC SP-4094-002 9018471871 00857834006551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other