BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 21919984 · Received April 28, 2025

    Report

    Report Number
    3013394970-2025-00199
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    November 2, 2024
    Report Date
    April 28, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED. THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE COMPLAINT WAS CONFIRMED FOR AN INFECTION REQUIRING SURGICAL INTERVENTION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT USE OF THE DEVICE AT THE JUNCTION OF THE CFA AND EIA CAUSED THE ISSUE TO OCCUR. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED SINCE A VALID LOT NUMBER WAS NOT IDENTIFIED. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA)/HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    A2: AGE: MID 80S. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. 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.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW "CHIO, JCT, GORDON, L, ROCHE-NAGLE, G. EMERGENCY AUTOLOGOUS VEIN GRAFT RECONSTRUCTION AFTER VASCULAR CLOSURE DEVICE USAGE AND SUBSEQUENT INFECTION. BMJ CASE REPORTS. 2024. 17:E260126": FROM THE CASE REPORT, A 6FR ANGIO-SEAL WAS FOLLOWING A BILATERAL ILIAC ARTERY STENTING FOR STENOSIS IN THE ILIAC LIMBS OF THE PATIENT'S PRIOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM ENDOGRAFT REPAIR. FOUR DAYS AFTER, THE PATIENT PRESENTED WITH A LEFT GROIN INFECTED HEMATOMA. THE PATIENT WAS ADMITTED FOR TREATMENT. ANGIO-SEAL WAS FOUND TO BE SUPERFICIAL TO THE ARTERY AT THE WOUND. THE SITE OF THE ANGIO-SEAL USE WAS A LONGITUDINAL TEAR IN THE ANTERIOR ARTERIAL WALL AT THE JUNCTIONAL AREA BETWEEN EXTERNAL ILIAC ARTERY (EIA) AND COMMON FEMORAL ARTERY (CFA). IT WAS DETERMINED THAT INFECTION WAS DETERMINED TO BE METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413469 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610132 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H| O ASPIRIN| RAMIPRIL| SIMVASTAIN