BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 24363591 · Received February 17, 2026

    Report

    Report Number
    3013394970-2026-00061
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 17, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: TELEPHONE NUMBER: REQUESTED, NOT PROVIDED. E3: OCCUPATION: (B)(6). 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.

    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. BASED ON THE EVALUATION OF THE RETURNED SAMPLE THIS REPORT IS NOW DEEMED NOT REPORTABLE. ONE (1) 6 FR ANGIO-SEAL VIP DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE INCLUDES THE HEMOSTASIS SHEATH AND ARTERIOTOMY LOCATOR. THE DEVICE WAS SUBJECTED TO VISUAL ANALYSIS. THE SHEATH AND LOCATOR ARE PARTIALLY ASSEMBLED. THE LOCKING COMPONENTS OF THE LOCATOR CONTAIN NO DEFORMITIES OR ABNORMALITIES. THE LOCATOR AND SHEATH ARE ABLE TO BE ASSEMBLED AND LOCK TOGETHER. THE SHEATH AND LOCATOR CONTAINED NO DEFECTS AND WERE ABLE TO BE FULLY ASSEMBLED. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED FOR SHEATH AND LOCATOR ASSEMBLY DIFFICULTIES. THE EXACT ROOT CAUSE OF THE COMPLAINT EVENT 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 MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: AN ANGIO-SEAL DEVICE REPORTEDLY WOULD NOT CLICK WHEN ARTERIOTOMY LOCATOR WAS INITIATED IN THE SHEATH. THERE WERE NO REPORTED INTRAOPERATIVE DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE SIZE OF THE PROCEDURE SHEATH SIZE IS UNKNOWN. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE PATIENT REMAINED IN STABLE CONDITION. HEMOSTASIS WAS ACHIEVED WITH A SECOND ANGIO-SEAL. THERE WAS NO BLOOD LOSS. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THE PROCEDURE FOR THE PATIENT PRIOR TO THE USE OF THE ANGIO-SEAL DEVICE WAS A LEG ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428096 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610130 0001197618 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown