BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 20579636 · Received October 31, 2024

    Report

    Report Number
    3013394970-2024-00563
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 31, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011813
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: (B)(6). ONE (1) 8FR ANGIOSEAL DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION FOR PRODUCT EVALUATION. THE RETURNED DEVICE WAS UNUSED AND UNOPENED. THE DEVICE WAS UNPACKAGED, AND ALL COMPONENTS WERE PRESENT WITHIN THE PACKAGING. THE HEMOSTASIS SHEATH WAS FOUND TO HAVE BEEN FRACTURED, AND THE COMPONENT WAS ALSO ABLE TO BE BROKEN IN A MANNER WHICH IS CONSISTENT WITH EMBRITTLEMENT DUE TO LIGHT EXPOSURE. THE COMPLAINT WAS CONFIRMED FOR A SHEATH BREAKAGE DUE TO LIGHT EXPOSURE. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN IMPROPER STORAGE AS THE DEVICE WAS BROKEN IN A MANNER WHICH IS CONSISTENT WITH EMBRITTLEMENT DUE TO LIGHT EXPOSURE. 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).

    Description of Event or Problem · 0

    THE USER FACILITY RETURNED AN UNUSED, UNOPENED ANGIO-SEAL DEVICE. THE DEVICE WAS BROKEN IN A MANNER CONSISTENT WITH SHEATH EMBRITTLEMENT DUE TO LIGHT EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848834 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610131 0000468609 00389701011813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown