BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 521615 · Received April 21, 2004

    Report

    Report Number
    2916596-2004-00054
    Event Type
    Other
    Date Received
    April 21, 2004
    Date of Event
    March 16, 2004
    Report Date
    March 16, 2004
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE MANUFACTURER CLINICAL SPECIALIST WAS VISITING THE CENTER TO PROVIDE CLINICAL SUPPORT IT WAS NOTED THAT THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) INFLOW CANNULA OF A BIVAD SUPPORTED PT APPEARED TO BE A BEVELED-TIP ATRIAL CANNULA SECURED WITH THE INCORRECT (BLACK) COLLET AND NUT. AFTER SPEAKING WITH THE IMPLANTING SURGEON AND VERIFYING BY X-RAY THAT THE BEVELED-TIP CANNULA WAS USED, THE DECISION WAS MADE BY THE SURGICAL TEAM TO EXCHANGE THE BLACK COLLET AND COLLET NUT WITH THE CORRECT (WHITE) COLLET AND COLLET NUT. THE EXCHANGE WAS MADE WITH OUT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention