BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELECT IVC FILTER

    MDR report key: 22955558 · Received September 3, 2025

    Report

    Report Number
    MW5175584
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 28, 2025
    Report Date
    August 28, 2025
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CELECT IVC FILTER FOUND TO BE FRACTURED, WITH HALF OF ONE LEG EMBEDDED DEEP IN VERTEBRAL BODY. FILTER WAS REMOVED BUT FRAGMENT IS RETAINED AS IT IS EXTRAVASCULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131565 CELECT IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other| R| L