BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT+ SUTURE DELIVERY DEVICE

    MDR report key: 4843698 · Received June 11, 2015

    Report

    Report Number
    3005802238-2015-00007
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 10, 2015
    Manufacturer
    SENTREHEART INC.
    Product Code
    HCF
    PMA / PMN Number
    K142241
    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. THE SUTURE WAS DEPLOYED AND TIGHTENED. AFTER A SECOND TIGHTENING BY THE PHYSICIAN, AN EFFUSION DEVELOPED AND THE PT EXPERIENCED HEMODYNAMIC ISSUES. THE PHYSICIAN ELECTED TO SEND THE PT TO SURGERY TO MANAGE THE EFFUSION. THE LLA WAS SUCCESSFULLY SUTURED AND THE PT WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380745 LARIAT+ SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE HCF SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention