BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCES

    MDR report key: 428480 · Received November 1, 2002

    Report

    Report Number
    MW1026745
    Event Type
    Malfunction
    Date Received
    November 1, 2002
    Date of Event
    October 24, 2002
    Report Date
    October 31, 2002
    Manufacturer
    EDWARD LIFESCIENCES, LLC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERICARDIAL SUMP USED TO VENT HEART IN AORTIC VALVE REPLACEMENT. WHEN WENT TO REMOVE, FOUND THAT THE METAL SPRING TIP WAS CAUGHT IN THE MITRAL CHORDAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCES PENCARDIAL SUMP DWF EDWARD LIFESCIENCES, LLC S1201 58121387

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other