BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 19152934 · Received April 19, 2024

    Report

    Report Number
    MW5154049
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 18, 2024
    Manufacturer
    ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AN ANGIO-SEAL DEVICE WAS DEPLOYED AFTER CATH TO RIGHT FEMORAL ON (B)(6) 2024. PATIENT REPORTED DISCOMFORT, WENT TO ED (EMERGENCY DEPARTMENT) AND CT (COMPUTED TOMOGRAPHY) DEMONSTRATED OCCLUSION OF RIGHT COMMON FEMORAL ARTERY. PATIENT RETURNED TO CATH LAB (B)(6) 2024 AND SUCCESSFUL REMOVAL OF ANGIO-SEAL. PATIENT DID WELL AND DISCHARGED TO HOME. SMALL AMOUNT OF BLOOD RESTRICTION CAUSED BY ANGIO-SEAL LIMITED FLOW CAUSING PAIN. REMOVED. PAIN THEN DECREASED TO HIS "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190187 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization