BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-28-QL-PFO

    MDR report key: 488222 · Received October 8, 2003

    Report

    Report Number
    1222632-2003-00017
    Event Type
    Injury
    Date Received
    October 8, 2003
    Date of Event
    September 4, 2003
    Report Date
    October 7, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT RECEIVED PFO CLOSURE, WITH A CARDIOSEAL SEPTAL OCCLUDER, VIA TRANSEPTAL PUNCTURE. PFO MEASURED 21MM WITH A LONG TUNNEL MORE THAN 2CM IN LENGTH. PT TOLERATED SURGERY WELL AND PROCEDURE WAS UNEVENTFUL. APPROX TWO HOURS POST-PROCEDURE PT HAD HYPOTENSION AND ECHO SHOWED CARDIAC TAMPONADE AND PERICARDIAL EFFUSION, AN APPARENT RESULT OF THE TRANSSEPTAL PUNCTURE. PERICARDIOCENTESIS WAS PERFORMED AND PT'S HEMODYNAMIC PROBLEMS RESOLVED IMMEDIATELY. FOLLOW-UP ECHO PERFORMED THE NEXT TWO DAYS SHOWED THE DEVICE IN GOOD POSITION AND NO RESIDUAL EFFUSION. PT DISCHARGED TWO DAYS AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-28-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-28-QL-PFO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention