BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX IAB CATH

    MDR report key: 782292 · Received November 14, 2006

    Report

    Report Number
    MW1040974
    Event Type
    Malfunction
    Date Received
    November 14, 2006
    Date of Event
    October 13, 2006
    Report Date
    November 14, 2006
    Manufacturer
    ARROW
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE WOULD NTO COME OUT AFTER INSERTION VIA RIGHT GROIN. ENTIRE BALLOON AND GUIDEWIRE REMOVED AND NEW BALLOON PLACED IN LEFT GROIN. PT STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROPTIX IAB CATH BALLOON DQY ARROW 40CC 8 FR MF6068947

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR