BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3810020 · Received May 1, 2014

    Report

    Report Number
    3005802238-2014-00006
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 30, 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 RETURNED FOR PHYSICAL EVALUATION. THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. ALSO, 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 LARIAT WAS ADVANCED TO THE BASE OF THE LAA WITHOUT INCIDENT. AFTER RELEASING THE LARIAT SNARE A 2MM LEAK WAS NOTED AND SUBSEQUENT BLEEDING FROM THE SHEATH. AN EFFUSION WAS NOTED ON TEE. A DRAIN WAS IMMEDIATELY AND SUCCESSFULLY PLACED TO MANAGE THE EFFUSION. THE DEVICE WAS TENSIONED TWICE BUT THE LEAK REMAINED. THE PHYSICIAN DECIDED TO SEND THE PATIENT TO SURGERY. THE CARDIAC SURGEON TIED OFF THE LAA AND REPAIRED WHAT APPEARED TO BE A SMALL LACERATION. PER THE PHYSICIAN, THE PATIENT WAS DOING WELL POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261863 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70513056

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention