BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE 6F

    MDR report key: 20225032 · Received September 16, 2024

    Report

    Report Number
    20225032
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 15, 2024
    Manufacturer
    VASORUM LIMITED
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CLOSURE DEVICE FAILURE DURING FEMORAL ARTERIAL SHEATH REMOVAL. RESULTING IN PARTIAL DEVICE LODGED IN PATIENT'S ARTERY. MANUAL PRESSURE HELD; HEMOSTASIS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472581 CELT ACD VASCULAR CLOSURE DEVICE 6F DEVICE, HEMOSTASIS, VASCULAR MGB VASORUM LIMITED KCLT-06 943065

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Other