BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHIC GUIDEWIRE

    MDR report key: 2589688 · Received May 8, 2012

    Report

    Report Number
    2589688
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 8, 2012
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE CASE THE GUIDEWIRE WAS BEING WIPED WITH A SPONGE MOISTENED WITH HEPARINIZED SALINE. WHEN THE SPONGE WAS OBSERVED AFTER WIPING THE GUIDEWIRE, A GREEN COLORED RESIDUE WAS NOTED ON THE SPONGE. THE PROCESS OF WIPING THE GUIDEWIRE WITH A SPONGE WAS REPEATED AND MORE GREEN COLORED RESIDUE WAS OBSERVED ON THE SPONGE. THE GUIDEWIRE AND SPONGES WERE SAVED. PACKAGING FOR THIS GUIDEWIRE WAS NOT SAVED. CUSTOMER SERVICE AT THE COMPANY WAS NOTIFIED AND GUIDEWIRE/SPONGES WILL BE RETURNED TO THE COMPANY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGRAPHIC GUIDEWIRE ANGIOGRAPHIC GUIDEWIRES DQX NAVILYST MEDICAL, INC. 197002002 GFWB1443

    Patients

    Seq Age Sex Outcome Treatment
    1 *