BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23600679 · Received November 19, 2025

    Report

    Report Number
    3013394970-2025-00800
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 19, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011806
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE (1) 6 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURN SAMPLE INCLUDES THE HEADER BAG, HEMOSTASIS SHEATH, AND THE ARTERIOTOMY LOCATOR. THE DEVICE UNDERWENT VISUAL ANALYSIS. THE DEVICE WAS OBSERVED TO BE IN A USED CONDITION AS THE SHEATH AND LOCATOR WERE FULLY MATED. A BEND DISTAL FROM THE BLOOD INLET HOLES WAS NOTED. ONE 6 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE SHEATH AND LOCATOR WERE RETURNED FULLY MATED WITH A BEND ON THE DILATOR OBSERVED DISTAL TO BLOOD INLET HOLES. THE COMPLAINT CAN BE CONFIRMED FOR A BEND IN THE DILATOR. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. A LIKELY CAUSE WAS DETERMINED TO HAVE BEEN DAMAGE SUSTAINED TO THE DILATOR DURING THE COMPONENT MATING. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES AND THE DEVICE WAS RELEASED IN A CONFORMING STATE. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A3A: SEX: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A4: WEIGHT: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A5: ETHNICITY: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A6: RACE: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THIS REPORT IS FOR THE SECOND DEVICE USED DURING THE CASE, FOR THE FIRST DEVICE USED IN THE CASE SEE SECTION H10 FOR THE RELATED REPORT NUMBER.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING SETUP, WHEN THE LOCATOR WAS INSERTED INTO THE INSERTION SHEATH, THE LOCATOR GOT KINKED. THE DEVICE WAS THEREFORE NOT USED AND WAS REPLACED WITH ANOTHER ANGIO-SEAL DEVICE. HOWEVER, THE SAME PROBLEM OCCURRED WITH THE SECOND DEVICE. THE SECOND DEVICE WAS THEREFORE NOT USED AND MANUAL COMPRESSION WAS APPLIED FOR FORTY MINUTES TO ACHIEVE HEMOSTASIS. SUBSEQUENTLY, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY MANUAL COMPRESSION ONLY. THE TYPE OF PROCEDURE WAS HEMOSTASIS. THE PROCEDURE BEFORE DEPLOYING THE DEVICE WAS PPI. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE SIZE OF THE SHEATH ANCILLARY USED WAS 6 FR. THE PUNCTURE SITE WAS PROXIMAL TO THE INGUINAL LIGAMENT OF THE RIGHT COMMON FEMORAL ARTERY. THE VESSEL DIAMETER WAS 5 MM. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661162 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610132 0001062471 00389701011806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown