BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE,OUS

    MDR report key: 19666688 · Received July 3, 2024

    Report

    Report Number
    3013394970-2024-00302
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    October 31, 2022
    Report Date
    July 3, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: INTERVENTIONAL NEURORADIOLOGY. THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT THE CARRIER TUBE AND HEMOSTASIS SHEATH SEPARATED DURING REAR-LOCKING, ALTHOUGH THIS WAS UNABLE TO BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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 REPORTED THAT DURING THE NEURORADIOLOGY PROCEDURE FOR THE IMPLANTATION OF THE ANGIO-SEAL 6F HEMOSTATIC SEALANT, AFTER THE NEURORADIOLOGY PROCEDURE, THE SYSTEM DISARMED/CAME APART (POSSIBLE ANCHORING PROBLEM). IT WAS NECESSARY TO REMOVE THIS DEVICE, AND, IN THIS CASE, WE OPTED FOR DIGITAL COMPRESSION FOLLOWED BY A COMPRESSION DRESSING. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE WAS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785697 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE,OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000177016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention