BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL

    MDR report key: 1023280 · Received April 1, 2008

    Report

    Report Number
    1222632-2008-00005
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 21, 2008
    Report Date
    April 1, 2008
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    PMA / PMN Number
    P000049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS CASE IS AVAILABLE FOR EVALUATION; A REVIEW OF OUR LOT HISTORY RECORD INDICATES THIS LOT PASSED ALL APPLICABLE TEST AND INSPECTIONS AND WAS RELEASED IN ACCORDANCE WITH OUR PROCEDURES GOVERNING LOT RELEASE. OUR INVESTIGATION INTO THIS MATTER IS PENDING RECEIPT OF THE IMPLANTATION/OPERATIVE CASE SUMMARIES, AND ALL RELEVANT PROCEDURAL FILMS WE HAVE REQUESTED FROM THE END-USER. UPON COMPLETION OF OUR INVESTIGATION, WE COMMUNICATED OUR FINDINGS VIA A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE END-USER REPORTED ENCOUNTERING DIFFICULTIES PLACING A 28 MM CARDIOSEAL ACROSS A LONG TUNNEL PFO. BASED ON THE INCIDENT NARRATIVE, THE DEVICE WOULD NOT FULLY OPEN IN THE LEFT ATRIUM, THE 28 MM DEVICE WAS SUCCESSFULLY RETRIEVED LOOSING ACCESS TO THE DEFECT. THE PHYSICIAN RE-GAINED ACCESS WITH A NEW TRANSEPTAL SHEATH, A NEW 28 MM DEVICE WAS ADVANCED TO THE DEFECT AND DEPLOYED WITH PROMISING RESULTS. THE PATIENT DEVELOPED PERICARDIAL EFFUSION SEVERAL HOURS FOLLOWING THE PROCEDURE. A PERICARDIAL CENTESIS WAS PERFORMED AND 100 CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITHOUT FURTHER COMPLICATIONS. THE PATIENT RETURNED FOR A FOLLOW-UP VISIT 2 WEEKS LATER, EVERYTHING WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CARDIOSEAL MLV NMT MEDICAL, INC. CS-28-VSD 0704253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other