BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 22965923 · Received September 4, 2025

    Report

    Report Number
    3013394970-2025-00570
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 4, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011813
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A3A: SEX: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A4: WEIGHT: REQUESTED, NOT PROVIDED DUE TO HOSPITAL POLICY. A5: ETHNICITY: NOT PROVIDED DUE TO HOSPITAL POLICY. A6: RACE: NOT PROVIDED DUE TO HOSPITAL POLICY. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL SUPPLY TECH. 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 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 CANNOT BE CONFIRMED FOR A DEVICE PULLOUT. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW DETERMINED THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AN 8 FRENCH ANGIO-SEAL WAS USED FOR AN ENDOLEAK YESTERDAY MORNING. IT WAS REPORTED THAT THE DEVICE DID NOT FUNCTION PROPERLY. THERE WAS NO SUTURE, AND THEY COULD NOT SEE ANY ANCHOR UNDER ULTRASOUND AFTER THE DEVICE MALFUNCTIONED. PRESSURE WAS HELD TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFUL, AND NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 20AUG2025: THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 27AUG2025: A 10 FRENCH PROCEDURAL SHEATH WAS USED. THERE WAS NO DIFFICULTY WITH ARTERIAL ACCESS, AND SHEATH INSERTION WAS SMOOTH. THERE WERE NO ISSUES WITH THE INSERTION OR THE DEVICE. HOWEVER, WHEN THE DEVICE WAS PULLED BACK FROM THE DEVICE SHEATH, IT WAS IMMEDIATELY NOTIFIED THAT THERE WAS NO SUTURE. THE DEVICE SHEATH AND MANUAL COMPRESSION WERE APPLIED. A STANDARD PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876593 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610131 0001014499 00389701011813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown