BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 18210091 · Received November 27, 2023

    Report

    Report Number
    3013394970-2023-00786
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 27, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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. E3: OCCUPATION: LAB DIRECTOR. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE 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 PROVIDE ADDITIONAL INFORMATION IN SECTION B5 AND TO REPORT THAT THIS REPORTED EVENT HAS BEEN REASSESSED AND DEEMED NOT REPORTABLE BASED UPON THE ADDITIONAL INFORMATION PROVIDED IN SECTION B5.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE FIT OF THE ARTERIOTOMY LOCATOR AND SHEATH WAS LOOSE. THE PROCEDURE PERFORMED WAS A LEFT LEG ANGIO. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: A NEW PRODUCT WAS OPENED UNTIL ONE FIT AND WAS UTILIZED TO ACHIEVE HEMOSTASIS. THERE WAS NO BLOOD LOSS, AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498298 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000355755 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown