BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3672002 · Received February 13, 2014

    Report

    Report Number
    3005802238-2014-00001
    Event Type
    Injury
    Date Received
    February 13, 2014
    Date of Event
    January 14, 2014
    Report Date
    February 13, 2014
    Manufacturer
    SENTREHEART INC.
    Product Code
    GAT
    PMA / PMN Number
    K090385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE. IT WAS NOTED THAT THE PATIENT HAD A DILATED LEFT ATRIUM. THE LAA WAS CAPTURED SUCCESSFULLY USING THE LARIAT; HOWEVER, AN EFFUSION DEVELOPED ALONG WITH A DROP IN BLOOD PRESSURE SHORTLY AFTER THE FIRST TIGHTENING OF THE SUTURE. A DRAIN WAS IMMEDIATELY PLACED FOLLOWED BY A BLOOD TRANSFUSION. THE BLEEDING WAS RESOLVED SURGICALLY. THE SURGEON NOTED A PERFORATION PROXIMAL TO WHERE THE SUTURE WAS DELIVERED. THE SURGEON FURTHER COMMENTED THAT THE LAA WAS "INCREDIBLY FRIABLE." THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94520 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention