BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 611703 · Received June 8, 2005

    Report

    Report Number
    2916596-2005-00080
    Event Type
    Other
    Date Received
    June 8, 2005
    Date of Event
    April 7, 2005
    Report Date
    April 7, 2005
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE IMPLANT OF A VENTRICULAR ASSIST DEVICE (VAD) THE SURGEON PLACED THE BLACK COLLET NUT ON THE ATRIAL CANNULA INSTEAD OF THE WHITE COLLET NUT AS PER DIRECTIONS FOR USE. AS THE PT WAS STILL IN A CRITICAL STATE A DECISION WAS MADE BY THE SURGEON TO NOT GO BACK AND CHANGE THE COLLET NUT. A CLINICAL REPRESENTATIVE FROM THE MANUFACTURER RE-EDUCATED THE CENTER ON THE PROPER COLLET NUT USAGE AND REINFORCED THE POTENTIAL RISKS FOR THE PT. THE INSTRUCTIONS FOR USE WARNS THAT FAILURE TO USE THE CORRECT COLLET AND COLLET NUT MAY RESULT IN INSECURE CANNULA ENGAGEMENT LEADING TO THE POSSIBILITY OF SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other