BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 23307016 · Received October 15, 2025

    Report

    Report Number
    3013394970-2025-00708
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 15, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011790
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE (1) 8 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE INCLUDES THE HEMOSTASIS SHEATH AND CARRIER TUBE. THE DEVICE WAS SUBJECTED TO VISUAL ANALYSIS. THE DEVICE APPEARS TO BE IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD. THE HEMOSTASIS SHEATH AND CARRIER TUBE ARE FULLY MATED IN REAR LOCK POSITION. ONE 8 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED DEVICE WAS FULLY MATED IN REAR LOCK POSITION. THEREFORE, THE COMPLAINT CAN BE CONFIRMED FOR A NONDEPLOYMENT DEVICE PULLOUT. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CAUSE IS THERE WAS OBSTRUCTION TO THE DEVICE TIP, PREVENTING THE ANCHOR FROM DEPLOYING AND POSTING. 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).

    Additional Manufacturer Narrative · 0

    . THE ACTUAL DEVICE HAS 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 FOLLOWING REPORTED INFORMATION: THE ANGIO-SEAL DEVICE WAS USED FOR HEMOSTASIS AFTER THE PERCUTANEOUS CORONARY INTERVENTION (PCI) THROUGH A RIGHT FEMORAL ARTERY PUNCTURE. THE HEMOSTASIS PROCEDURE PROCEEDED AS USUAL, BUT WHEN THE DEVICE/SHEATH ASSEMBLY WAS WITHDRAWN AFTER POSITIONING, THE ANCHOR DID NOT COME OUT OF THE INSERTION SHEATH, AND THE DEVICE/SHEATH ASSEMBLY WAS WITHDRAWN TOGETHER, RESULTING IN HEMOSTASIS FAILURE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. SUBSEQUENTLY, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY MANUAL COMPRESSION ONLY. THE PROCEDURE BEFORE DEPLOYING THE DEVICE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE SIZE OF THE SHEATH ANCILLARY USED WAS 7 FR. THE PUNCTURE SITE WAS DISTAL TO THE INGUINAL LIGAMENT OF THE RIGHT COMMON FEMORAL ARTERY. THE VESSEL DIAMETER WAS 7 MM. THE ESTIMATED BLOOD LOSS WAS LESS THEN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THE PHYSICIAN STATED THAT THE HEMOSTASIS PROCEDURE PROCEEDED AS USUAL, HOWEVER, THERE WAS NO SENSATION THAT THE ANCHOR WAS CAUGHT AGAINST THE VESSEL WALL, AND THE DEVICE/SHEATH ASSEMBLY CAME OUT. UPON INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE ANCHOR WAS NOT EXPOSED FROM THE INSERTION SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471416 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610133 0001105070 00389701011790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown