BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 4151931 · Received October 6, 2014

    Report

    Report Number
    3005802238-2014-00009
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 1, 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

    ACCESS TO THE LAA WAS UNEVENTFUL; HOWEVER, IT WAS DIFFICULT TO ADVANCE THE LARIAT TOWARDS THE BASE OF THE LAA TO CAPTURE THE ENTIRE LAA. MULTIPLE ATTEMPTS WERE REQUIRED. AN EFFUSION DEVELOPED AND THE PATIENT BECAME REQUIRED HEMODYNAMICALLY UNSTABLE. THE SURGEON WAS CONSULTED AND IT WAS DECIDED THAT THE PATIENT BE BROUGHT TO THE OR TO RESOLVE THE BLEEDING. THE SURGEON INFORMED US THE PATIENT STABILIZED AND THAT THE ENTIRE LAA WAS ENCAPSULATED BY ADHESIONS, WHICH CAUSED THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623033 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention