BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE CORING KNIFE

    MDR report key: 612975 · Received July 20, 2004

    Report

    Report Number
    2916596-2004-00096
    Event Type
    Malfunction
    Date Received
    July 20, 2004
    Date of Event
    June 25, 2004
    Report Date
    June 25, 2004
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, THE PT WAS IMPLANTED WITH A VENTED ELECTRIC BENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PERFUSIONIST THAT DURING THE IMPLANT, THE CORING KNIFE WAS DULL AND THE SURGEON WAS UNABLE TO CUT THE VENTRICULAR TISSUE. AT THAT TIME A BACK-UP CORING KNIFE WAS OPENED AND USED, AND THE ISSUE WAS RESOLVED. THE HOSPITAL PERFUSIONIST IS RETURNING THE CORING KNIFE TO THE MFR FOR ANALYSIS. THE PT REN=MAINS ON LVAD SUPPORT WHILE AWAITING A HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE CORING KNIFE APICAL CORING KNIFE DSQ THORATEC CORP. 1050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention