BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 22040864 · Received May 16, 2025

    Report

    Report Number
    3013394970-2025-00248
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    June 1, 2024
    Report Date
    May 16, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: UNKNONW. A2: AGE AND DATE OF BIRTH: UNKNOWN. A3A: SEX: UNKNOWN. A4: WEIGHT: UNKNOWN. A5: ETHNICITY: UNKNOWN. A6: RACE: UNKNOWN. D6A: IMPLANTED DATE: DATE UNKNOWN. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. D4: CATALOG NUMBER: UNKNOWN. D4: LOT NUMBER: UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN CATALOG NUMBER AND LOT NUMBER. D4: UDI: UNKNOWN DUE TO UNKNOWN CATALOG NUMBER AND LOT NUMBER. E1: ADDRESS: UNKNOWN. E1: PHONE NUMBER: UNKNOWN. E3: OCCUPATION: UNKNOWN. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN CATALOG NUMBER AND LOT NUMBER. THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. THE COMPLAINT WAS CONFIRMED FOR A POTENTIAL BLEEDING ISSUE. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE REVIEWED SINCE A VALID LOT NUMBER WAS NOT IDENTIFIED. THERE IS NO INDICATION THAT ANY MANUFACTURING, DESIGN, OR QUALITY SYSTEM ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILUR MODE AND EFFECTS ANALYSIS (FMEA)/HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    PER LITERATURE REVIEW: ADAMS, ALYNAH J., DYER, MITCHELL, KUGLER, NATHAN W., YANG, KAI, HIEB, ROBERT A., ROSSI, PETER. SAFETY OF PLUG-MEDIATED VASCULAR CLOSURE FOR PROSTHETIC ARTERIAL GRAFT PUNCTURE. JOURNAL OF VASCULAR SURGERY. 2024. 79:E303. IN A RETROSPECTIVE STUDY ON THE SAFETY OF ANGIO-SEAL VIP IN THE PUNCTURE OF PROSTHETHIC GRAFT, ONE PATIENT WAS HAD BLEEDING THAT REQUIRED OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128552 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention