BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23512271 · Received November 10, 2025

    Report

    Report Number
    3013394970-2025-00798
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 10, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011790
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E1: CONTACT NAME: UNKNOWN. E1: TELEPHONE NUMBER: UNKNOWN. E3: OCCUPATION: UNKNOWN. 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.

    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) 8FR ANGIO-SEAL DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION FOR PRODUCT EVALUATION. THE RETURNED SAMPLE INCLUDED THE HEADER BAG, GUIDEWIRE, CARRIER TUBE, ARTERIOTOMY LOCATOR, AND HEMOSTASIS SHEATH. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN UNUSED CONDITION. A KINK WAS NOTED AT THE BLOOD INLET HOLE OF THE LOCATOR. THE ANGIO-SEAL DEVICE WAS RETURNED FOR EVALUATION AND A KINK WAS NOTED AT THE BLOOD INLET HOLES OF THE ARTERIOTOMY LOCATOR. BASED ON THE CONDITION OF THE DEVICE, THE COMPLAINT COULD BE CONFIRMED FOR A KINKED LOCATOR. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN DAMAGE SUSTAINED TO THE LOCATOR DURING DEVICE UNPACKING DUE TO HANDLING. 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).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHEN OPENING THE PACKAGE, THE DILATOR WAS FOUND BENT. THIS ANGIO-SEAL WAS NOT USED AND BE REPLACED WITH ANOTHER ANGIO-SEAL TO SUCCESSFULLY FINISH THE PROCEDURE. THERE WAS NO BLOOD LOSS. THE PATIENT'S PRE-PROCEDURAL CONDITION, CURRENT MEDICATIONS (INCLUDE DOSAGES), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. RELEVANT TESTS AND LAB RESULTS INCLUDING DATES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524595 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610133 0000871174 00389701011790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown