BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 24442932 · Received February 25, 2026

    Report

    Report Number
    3013394970-2026-00055
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 25, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: NEUROINTERVENTIONAL FELLOW, 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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT MEDICAL PRODUCTS: TERUMO MEDICAL CORP INTRODUCER/SHEATH, LOT NUMBER 0001332974, TERUMO MEDICAL CORP CATHETER, DIAGNOSTIC IMAGING - ANGIOGRAPHIC, LOT NUMBER 250909, TERUMO MEDICAL CORP CLOSURE DEVICE, LOT NUMBER 0001281099.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE COMPLETE 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 AS THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION. WITHOUT A SAMPLE, 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 ARE NO INDICATIONS MANUFACTURING ISSUES MAY HAVE LED TO THIS EVENT. NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS.

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A NEURO ANGIOGRAM, THE ANGIO-SEAL DEVICE WAS ATTEMPTED TO BE USED. AFTER GAINING OPTIMAL POSITION WITH THE LOCATOR, THE LOCATOR WAS REMOVED AND THE DEVICE WAS INSERTED. THE PHYSICIAN STATED THE DEVICE DID NOT CLICK; HOWEVER, AFTER EXAMINATION THE DEVICE WAS DEEMED OKAY FOR USE. THE PHYSICIAN PULLED BACK FOR A SECOND CLICK TO DEPLOY THE DEVICE; HOWEVER, ALL COMPONENTS CAME OUT; THEREFORE, ANOTHER DEVICE WAS SUCCESSFULLY USED. THE PROCEDURE SHEATH SIZE USED WAS 6 FRENCH. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE WERE NO ISSUES WITH INSERTION OF SHEATH AND ARTERIOTOMY LOCATOR. NO BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165319 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610130 0001281099 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male COOK INC. INTRODUCER/SHEATH.| MERIT MEDICAL SYSTEMS, INC. VALVE.| TERUMO MEDICAL CORP CATHETER, DIAGNOSTIC IMAGING.| TERUMO MEDICAL CORP CLOSURE DEVICE.| TERUMO MEDICAL CORP GUIDEWIRE, LOT NUMBER 250804.| TERUMO MEDICAL CORP INTRODUCER/SHEATH.| TERUMO MEDICAL CORP INTRODUCER/SHEATH.