BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23617185 · Received November 21, 2025

    Report

    Report Number
    23617185
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    September 26, 2025
    Report Date
    November 4, 2025
    Manufacturer
    TERUMO MEDICAL CORP
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE DID NOT FULLY CLICK TO DEPLOY. MANUFACTURER RESPONSE FOR VASCULAR CLOSURE DEVICE, 6FR ANGIOSEAL (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464262 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORP 610130 1082817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown