BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23901503 · Received December 27, 2025

    Report

    Report Number
    3013394970-2025-00913
    Event Type
    Malfunction
    Date Received
    December 27, 2025
    Date of Event
    December 7, 2025
    Report Date
    December 27, 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

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. ONE (1) 8FR ANGIO SEAL DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE RETURNED SAMPLE INCLUDED THE CARRIER TUBE, HEMOSTASIS SHEATH, LOCATOR, GUIDEWIRE, AND PACKAGING. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN UNUSED CONDITION. THE HEMOSTASIS SHEATH WAS FOUND TO HAVE BEEN KINKED. NO OTHER DAMAGE OR ISSUES WERE IDENTIFIED. ONE (1) 8FR ANGIO SEAL DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE HEMOSTASIS SHEATH WAS FOUND TO HAVE BEEN KINKED. THE COMPLAINT WAS CONFIRMED FOR A KINKED HEMOSTASIS SHEATH. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN DAMAGE SUSTAINED BY THE DEVICE DUE TO HANDLING DURING UNPACKAGING. THE DEVICE HISTORY RECORD (DHR) REVIEW DETERMINED THAT THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING, DESIGN, OR QUALITY SYSTEM ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA).

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: CONTACT: REQUESTED, UNKNOWN. E3: OCCUPATION: UNKNOWN HEALTHCARE PROFESSIONAL. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SHEATH WAS FOUND BENT WHEN OPENING THE PACKAGE. THEY CHANGED FOR ANOTHER ANGIO-SEAL TO FINISH THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 11DEC2025: THE SHEATH WAS TAKEN FROM THE PACKAGE AND FOUND KINKED. THE PATIENT WAS STABLE AND A NEW DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590925 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610133 0001266659 00389701011790

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male