BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC LEFT HEART KIT

    MDR report key: 2617284 · Received May 8, 2012

    Report

    Report Number
    2617284
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 8, 2012
    Manufacturer
    NAVILYST MEDICAL INC
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STAFF MEMBER OPENED A LEFT HEART KIT AND OPENED THE PACKAGING AND USED A 3 MM J ANGIOGRAPHIC GUIDEWIRE, NAVILYST BRAND. WHEN WIPING THE GUIDEWIRE WITH A 4X4 THAT WAS MOISTENED WITH HEPARINIZED SALINE, A GREEN COLORED FILM WAS NOTED ON THE 4X4. THE GUIDEWIRE WAS LOOKED AT CLOSELY AND STAFF NOTED THAT THE GUIDEWIRE APPEARED GREEN IN COLOR. CUSTOMER SERVICE AT NAVILYST WAS CONTACTED AND THIS REPORT WAS ADDED TO THE PREVIOUS REPORT. THE GUIDEWIRE AND 4X4 WILL BE SENT TO NAVILYST FOR FURTHER INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC LEFT HEART KIT CARDIOVASCULAR PROCEDURE KIT OEZ NAVILYST MEDICAL INC * GFWB1443

    Patients

    Seq Age Sex Outcome Treatment
    1 *