BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE APICAL CORING KNIFE

    MDR report key: 1860302 · Received September 22, 2010

    Report

    Report Number
    2916596-2010-00238
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    EMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL LVAD COORDINATOR THAT DURING THE IMPLANT PROCEDURE, WHILE CORING OF THE LEFT VENTRICULAR, THE CORING KNIFE WAS FOUND TO BE DULL. THE SURGEON THEN DECIDED TO USE A SCALPEL TO FINISH CORING THE LEFT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE APICAL CORING KNIFE APICAL CORING KNIFE EMF THORATEC CORP. 1050 94212

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR