BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINESSE ULTRA

    MDR report key: 2963274 · Received February 13, 2013

    Report

    Report Number
    2963274
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WAS HAVING AN US GUIDED CORE BIOPSY OF RIGHT BREAST. PROCEDURE WAS COMPLETED WITH 2 PASSES/SAMPLES THROUGH THE LESION AND DEPLOYMENT OF THE BIOPSY CLIP MARKER. SAMPLE CLIP WAS RETRIEVED FROM THE BIOPSY DEVICE AND NO TISSUE WAS PRESENT.IT WAS STATED THAT THE REP DID AN UPDATE ON THE DRIVER. THE DEPARTMENT DID NOT KEEP THE INFORMATION SO IT IS VERY LIMITED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?US GUIDED BREAST BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64052 FINESSE ULTRA INSTRUMENT, BIOPSY, BREAST KNW BARD PERIPHERAL VASCULAR, INC. * 91001905

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES| US GUIDED BIOPSY