BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 24319742 · Received February 11, 2026

    Report

    Report Number
    3013394970-2026-00042
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 11, 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

    ONE (1) 8FR ANGIO-SEAL DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION FOR PRODUCT EVALUATION. THE RETURNED DEVICE INCLUDED THE HEADER BAG, GUIDEWIRE, HEMOSTASIS SHEATH, CARRIER TUBE, AND ARTERIOTOMY LOCATOR. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD. THE HEMOSTASIS SHEATH AND CARRIER TUBE WERE RETURNED FULLY MATED AND FULLY REAR LOCKED WITH THE INTERNAL COMPONENTS DEPLOYED. A KINK WAS NOTED NEAR THE DISTAL TIP OF THE SHEATH. THE ANGIO-SEAL DEVICE WAS RETURNED FOR EVALUATION. AS A KINK WAS NOTED NEAR THE DISTAL TIP OF THE SHEATH THE COMPLAINT CAN BE CONFIRMED FOR MECHANICAL DAMAGE SUSTAINED TO THE SHEATH. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT DAMAGE TO THE SHEATH RESULTED IN DIFFICULTY WITH DEVICE ADVANCEMENT. 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

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTEDA1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED . D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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 PATIENT UNDERWENT CARDIAC PERCUTANEOUS CORONARY INTERVENTION (PCI) SURGERY. AFTER THE PROCEDURE, THE OPERATOR PERFORMED CLOSURE. THE OPERATOR EXCHANGED THE SHEATH AND INSERTED THE MAIN BODY OF THE CLOSURE DEVICE. RESISTANCE WAS ENCOUNTERED DURING DELIVERY, PREVENTING ITS ADVANCEMENT. REPEATED ATTEMPTS WERE UNSUCCESSFUL, AND THE PRODUCT WAS WITHDRAWN AND COMPRESSION WAS USED FOR HEMOSTASIS. THERE WAS NO INJURY CAUSED TO THE PATIENT DURING THE PROCESS. THERE WAS NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218923 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610133 0001281081 00389701011790

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male