BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23467950 · Received November 4, 2025

    Report

    Report Number
    3013394970-2025-00773
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 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
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE A CORRECTION TO SECTION D9, THE COMPLETED INVESTIGATION RESULTS. THE INITIAL MDR STATED "15-OCT-2025" IN SECTION D9; HOWEVER, THE DEVICE WAS NOT RETURNED TO TERUMO MEDICAL CORPORATION. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. AS OF 02DEC2025, THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. IF THE SAMPLE IS EVER RECEIVED, THEN THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY. THE ANGIO-SEAL DEVICE WAS UNAVAILABLE FOR EVALUATION. SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE DURING ATTEMPTED REAR LOCKING OF THE DEVICE, RESISTANCE WAS FELT PREVENTING PROPER DEVICE DEPLOYMENT, HOWEVER THIS CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES AND THE DEVICE WAS RELEASED IN A CONFORMING STATE. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E3: OCCUPATION: IR MANAGER. THE ACTUAL DEVICE HAS NOT BEEN 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

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DEVICE WAS INSERTED FINE; HOWEVER, WHEN THE DEVICE WAS PULLED BACK TO CLICK (LOCK DEVICE), IT WOULD NOT LOCK INTO PLACE. THERE WAS NO ESTIMATED BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 19OCT2025: THE PROCEDURE PERFORMED FOR THE PRIOR TO USE OF THE ANGIO-SEAL WAS RENAL ANGIO. AN 8 FRENCH PROCEDURE SHEATH WAS USED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE WERE NO ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE, ASIDE FROM DESCRIBED ISSUE. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE DEVICE DID NOT PULL OUT OF THE PATIENT'S ANATOMY; THE DEVICE STAYED IN THE ANATOMY AND ACHIEVED CLOSURE. THE PATIENT WAS STABLE. HEMOSTASIS WAS ACHIEVED PRIMARILY WITH THE ANGIO-SEAL AND THE PHYSICIAN HELD PRESSURE FOR FIFTEEN (15) MINUTES AS WELL. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE ANGIO-SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841117 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610131 0000819528 00389701011813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown