BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT AND SUTURE DELIVERY SYSTEM

    MDR report key: 4787979 · Received May 18, 2015

    Report

    Report Number
    4787979
    Event Type
    Death
    Date Received
    May 18, 2015
    Date of Event
    April 3, 2015
    Report Date
    May 15, 2015
    Manufacturer
    SENTRE HEART INC
    Product Code
    GAT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLICATION DURING LARIAT PROCEDURE. RESISTANCE WAS ENCOUNTERED WHEN THE LOOP OF THE LARIAT DEVICE WAS ATTEMPTED TO BE RETRACTED. THE LOOP WAS PARTIALLY CLOSED AND REOPENED, IT WAS ROTATED CLOCKWISE AND COUNTER CLOCKWISE AND ADVANCEMENT OF THE PERICARDIAL CANNULA WAS ATTEMPTED TO NO AVAIL. PT BECAME HYPOTENSIVE AND TACHYCARDIC. TEE SHOWED A PERICARDIAL EFFUSION AND A PERICARDIAL DRAIN WAS INSERTED. A LARGE VOLUME OF FRESH HEMOPERICARDIUM WAS ASPIRATED AND AUTO-TRANSFUSED INTO THE LEFT FEMORAL VEIN INTRODUCER SHEATH. PT TAKEN EMERGENTLY TO CARDIOVASCULAR SURGERY. EXPLORATION OF THE CHEST ATTEMPTED WITH REPAIR OF ATRIAL APPENDAGE, PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321282 LARIAT AND SUTURE DELIVERY SYSTEM NONE GAT SENTRE HEART INC 1140414

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death