BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-40-QL-PFO

    MDR report key: 376347 · Received February 12, 2002

    Report

    Report Number
    1222632-2002-00001
    Event Type
    Injury
    Date Received
    February 12, 2002
    Date of Event
    January 11, 2002
    Report Date
    February 12, 2002
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY TO THE CO'S CLINICAL MARKET SPECIALIST. "DURING THE PLACEMENT OF THE DEVICE TO CLOSE A "PFO" SIMULTANEOUSLY WITH THE RELEASE OF THE OCCLUDER FROM THE DELIVERY SYSTEM, THE OCCLUDER EJECTED THROUGH THE PFO INTO THE LEFT ATRIUM. SINCE THE OCCLUDER COULD NOT BE COLLAPSED AND RECOVERED THROUGH A SHEATH, IT WAS SURGICALLY REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-40-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-40-QL-PFO 0106077

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention