BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIV SUTURE CATCHER

    MDR report key: 6064477 · Received October 28, 2016

    Report

    Report Number
    3003502395-2016-00140
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 8, 2014
    Report Date
    January 19, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NUMBER (B)(4) UPON INSPECTION THE COMPLAINT WAS CONFIRMED UPON RECEIPT. THE PIECE THAT BROKE OFF THE DEVICE WAS NOT RETURNED. UNRELATED TO THIS COMPLAINT, THE DEVICE DID NOT HAVE A SERIAL NUMBER ETCHED PER PRINT 635-13513.D.

    Description of Event or Problem · 1

    DURING A MITRAL VALVE REPAIR, THE TIP BROKE OFF OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714503 LIV SUTURE CATCHER LIV SUTURE CATCHER DWS ATRICURE, INC. 001-340-7475

    Patients

    Seq Age Sex Outcome Treatment
    1