BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 274050 · Received April 18, 2000

    Report

    Report Number
    2182269-2000-00044
    Event Type
    Injury
    Date Received
    April 18, 2000
    Date of Event
    August 19, 1999
    Report Date
    April 18, 2000
    Manufacturer
    DAIG CORP
    Product Code
    MGB
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DAIG CORP RECEIVED A USER MEDWATCH REPORT (#050367-0-0000) WHICH WAS INITIALLY SENT TO KENDALL THE MFR. IT WAS REPORTED THAT FOLLOWING A CARDIAC CATHETERIZATION PROCEDURE, AN ANGIO-SEAL DEVICE WAS DEPLOYED. THIRTY (30) MINUTES POST PROCEDURE, THE PT DEVELOPED AN ISCHEMIC LEFT FOOT AND NO PULSES WERE PRESENT. THE PT WAS TAKEN TO SURGERY FOR AN EMERGENCY THROMBECTOMY. LIMITED INFO IS AVAILABLE FOLLOWING SEVERAL UNSUCCESSFUL ATTEMPTS TO OBTAIN INFO FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE 8F ANGIO-SEAL MGB DAIG CORP 610089 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR