BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3732896 · Received March 26, 2014

    Report

    Report Number
    3005802238-2014-00004
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 26, 2014
    Manufacturer
    SENTREHEART INC.
    Product Code
    DQX
    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. A SMALL EFFUSION DEVELOPED AFTER MULTIPLE ATTEMPTS TO CAPTURE THE LAA. A DRAIN WAS IMMEDIATELY AND SUCCESSFULLY PLACED TO MANAGE THE EFFUSION. ANOTHER ATTEMPT WAS MADE TO CAPTURE AND LIGATE THE LAA TO RESOLVE THE EFFUSION, BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS THEN SENT TO SURGERY WHERE THE BLEEDING WAS RESOLVED BY SUTURING THE LAA. HE NOTED THAT THE LAA WAS ADHERED INFERIORLY TO THE MYOCARDIUM AND ANTERIORLY TO THE PULMONARY ARTERY. PER THE PHYSICIAN THE PATIENT IS AT HOME AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176768 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE DQX SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention