BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 24796139 · Received April 6, 2026

    Report

    Report Number
    3013394970-2026-00187
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 6, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011790
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED . D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: CONTACT: REQUESTED, UNKNOWN. E1: TELEPHONE NUMBER: REQUESTED, UNKNOWN. E3: OCCUPATION: REQUESTED, UNKNOWN. 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

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. ONE (1) 8 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE INCLUDES THE HEMOSTASIS SHEATH, ARTERIOTOMY LOCATOR, CARRIER TUBE, GUIDEWIRE AND HEADER BAG. THE DEVICE WAS SUBJECTED TO VISUAL ANALYSIS. THE DEVICE APPEARS TO BE IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD. THE CARRIER TUBE IS IN FORWARD LOCK POSITION. THE ANCHOR IS PRESENT AND THE BYPASS TUBE IS DISLODGED. ADDITIONALLY, A PICTURE WAS PROVIDED OF THE DEVICE. THE PICTURE SHOWS THE CARRIER TUBE WITH BLOOD PRESENT ON THE TIP. THE BYPASS TUBE IS PRESENT AND THE ANCHOR IS PRESENT. ONE 8 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION, AND A PICTURE WAS PROVIDED OF THE DEVICE. THE RETURNED CARRIER TUBE WAS IN USED CONDITION, WITH THE ANCHOR PRESENT. THE PICTURE SHOWS THE CARRIER TUBE WITH BLOOD PRESENT ON THE TIP, AND THE ANCHOR ATTACHED. THEREFORE, THE COMPLAINT CAN BE CONFIRMED FOR A 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 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 MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT DURING CLOSURE, THE ENTIRE CLOSURE DEVICE WAS PULLED OUT DIRECTLY WHEN TENSION WAS APPLIED TO THE SUTURE. AFTER REMOVAL, THE CONDITION OF THE ANCHOR WAS OBSERVED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE ASSEMBLED LOCATOR AND SHEATH WERE DIFFICULT TO INSERT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANGIO-SEAL DEVICE. PATIENT REMAINED IN STABLE CONDITION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WAS NO BLOOD LOSS. THE PROCEDURE BEFORE THE USE OF THE ANGIO-SEAL DEVICE WAS CORONARY INTERVENTION THERAPY USING A 6FR PROCEDURAL SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241788 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610133 0001341729 00389701011790

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female