BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVEGATE

    MDR report key: 3666654 · Received December 19, 2013

    Report

    Report Number
    3666654
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    December 9, 2013
    Report Date
    December 19, 2013
    Manufacturer
    GEISTER SURGICAL INSTRUMENTS
    Product Code
    DTH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A MINIMALLY INVASIVE MITRAL VALVE PROCEDURE, THE SURGEON WENT TO USE THE SUTURE CATCHER AND NOTICED THAT THE TIP WAS BENT. THE SURGEON UNBENT THE INSTRUMENT HOOK BY USING A NEEDLE HOLDER. WHEN THE INSTRUMENT WAS USED, THE TIP BROKE OFF WHEN BEING PULLED OUT OF THE PT. THE SURGEON FELT THAT THE TIP MAY BE IN THE SUBCUTANEOUS TISSUE IN THE RIGHT CHEST OF THE PT. TIP WAS NOT RETRIEVED. REF MFR REPORT NUMBER 2953686-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666996 VALVEGATE SUTURE CATCHER DTH GEISTER SURGICAL INSTRUMENTS 34-7475 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR