BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD

    MDR report key: 25175403 · Received May 14, 2026

    Report

    Report Number
    MW5188257
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 11, 2026
    Manufacturer
    VASORUM
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING A GENICULATE ARTERY EMBOLIZATION (GAE) PROCEDURE TO REDUCE SWELLING IN MY ARTHRITIC KNEE, THE CELT ARTERIAL CLOSURE DEVICE HAD AN ISSUE WITH THE FOOTPLATE WHICH RESULTED IN A TEAR OF THE FEMORAL ARTERY ON MY LEFT LEG. I UNDERWENT EMERGENCY BYPASS SURGERY THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384143 CELT ACD DEVICE, HEMOSTASIS, VASCULAR MGB VASORUM

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Disability| O| L| R| H