BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL OCL-017

    MDR report key: 261790 · Received February 10, 2000

    Report

    Report Number
    1222632-2000-00001
    Event Type
    Injury
    Date Received
    February 10, 2000
    Date of Event
    January 27, 2000
    Report Date
    February 8, 2000
    Manufacturer
    NMT MEDICAL INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A DEVICE IMPLANTATION UNDER "HDE" REGULATION. PT SUFFERED AN AIR EMBOLUS THAT RESULTED IN A CARDIAC ARREST, AND THE NEED FOR URGENT EXTRA-CORPOREAL MEMBRANE OXYGENATION SUPPORT. THE EMBOLUS OCCURRED DUE TO AIR IN THE DELIVERY SHEATH, AS THE DEVICE WAS BEING INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL OCL-017 CARDIOSEAL MLV NMT MEDICAL INC. OCL-017 9909065

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention