BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS MEDICAL INC.

    MDR report key: 335749 · Received June 1, 2001

    Report

    Report Number
    2134151-2001-00001
    Event Type
    Malfunction
    Date Received
    June 1, 2001
    Date of Event
    April 19, 2001
    Report Date
    May 13, 2001
    Manufacturer
    ATS MEDICAL INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS PREPARING TO IMPLANT THE VALVE IN THE AORTIC POSITION. HE NOTICED THE VALVE HAS BEEN PLACED ON THE DISPOSABLE VALVE HOLDER IN A POSITION REVERSED FROM NORMAL. THE PHYSICIAN REMOVED THE VALVE FROM THE HOLDER, REVERSED IT TO THE CORRECT POSITION AND IMPLANTED THE VALVE CORRECTLY. PATIENT RECOVERED WITHOUT ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25716 ATS MEDICAL INC. MECHANICAL HEART VALVE LWQ ATS MEDICAL INC. 500FA23 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention