BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELT ACD PLUS VASCULAR CLOSURE DEVICE 5F

    MDR report key: 24788948 · Received April 6, 2026

    Report

    Report Number
    24788948
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 26, 2026
    Manufacturer
    PROMEDIC CONSULTING LLC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 5F CELT ACD PLUS VASCULAR CLOSURE DEVICE WAS USED ON A PATIENT. THE METALLIC CLIP DID NOT CLOSE THE VESSEL WALL. IT DETACHED AND MIGRATED TO A MUSCULAR BRANCH IN THE RIGHT PROFUNDA. DR. DID NOT HAVE TO RETRIEVE THE METALLIC CLIP, BECAUSE IT WAS CAUSING NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28851 CELT ACD PLUS VASCULAR CLOSURE DEVICE 5F DEVICE, HEMOSTASIS, VASCULAR MGB PROMEDIC CONSULTING LLC CLT-05 943577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other