BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARIAT

    MDR report key: 4776991 · Received May 14, 2015

    Report

    Report Number
    4776991
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 14, 2015
    Manufacturer
    SENTREHEART, INC.
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS INSERTED INTO THE PATIENT'S BODY AND READY TO DEPLOY. AT THAT TIME, THE DOCTOR DISCOVERED THAT HE WAS UNABLE TO DEPLOY AND FOUND THAT THE PRODUCT WAS MALFUNCTIONING. HE WITHDREW THE PRODUCT AND REPLACED IT WITH A NEW LARIAT SUTURE DELIVERY SYSTEM, THE SECOND ONE WENT SMOOTHLY AND DEPLOYED SUCCESSFULLY. NO INJURY TO THE PATIENT. THE PATIENT DISCHARGED TO HOME ON THE NEXT DAY AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315494 LARIAT SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SENTREHEART, INC. * 02150447

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR UNKNOWN AT THIS TIME