BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23816150 · Received December 16, 2025

    Report

    Report Number
    3013394970-2025-00893
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 16, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011806
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: DISTRIBUTOR. ONE (1) 6 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE INCLUDES THE HEMOSTASIS SHEATH, ARTERIOTOMY LOCATOR, CARRIER TUBE, AND HEADER BAG. THE DEVICE WAS SUBJECTED TO VISUAL ANALYSIS. THE DEVICE APPEARS TO BE IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD ON THE DEVICE. THE HEMOSTASIS SHEATH AND ARTERIOTOMY LOCATOR ARE FULLY MATED. THE SHEATH TIP IS DEFORMED. NO ABNORMALITIES ARE NOTED WITH THE CARRIER TUBE OR LOCATOR. ONE 6 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE HEMOSTASIS SHEATH TIP WAS FOUND TO BE DEFORMED. THEREFORE, THE COMPLAINT CAN BE CONFIRMED FOR HEMOSTASIS SHEATH DEFORMATION. AN INVESTIGATION WAS PERFORMED BY THE MANUFACTURING FACILITY, AND IT WAS FOUND THAT THE LIKELY ROOT CAUSE WAS HUMAN ERROR AS THE DEFECTIVE UNIT WAS NOT IDENTIFIED DURING INSPECTION. THE DETECTION METHOD IS MANPOWER, BUT THE DETECTION FAILED TO IDENTIFY THE DEFECT. AN AWARENESS WAS PROVIDED IN RESPONSE TO THE INCIDENT. THE DEVICE HISTORY RECORD REVIEW DETERMINED THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE OPERATOR FOUND OUT THE TIP OF THE ANGIO-SEAL BODY WAS FLARED WHEN THEY OPENED THE PACKAGE. THEY EVENTUALLY CONTINUED THE PROCEDURE WITH A NEW ANGIO-SEAL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE FLARED COMPONENT AT THE CARRIER TUBE TIP WAS DUE TO THE BYPASS TUBE BEING DISLODGED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE FOR THE PATIENT WAS TRANSARTERIAL CHEMOEMBOLIZATION (TACE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875967 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610132 0001021714 00389701011806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown