BEUDAMED
    FDA Adverse Event Other Summary report: N

    GALEO F

    MDR report key: 720151 · Received May 24, 2006

    Report

    Report Number
    1028232-2006-00072
    Event Type
    Other
    Date Received
    May 24, 2006
    Date of Event
    February 2, 2006
    Report Date
    May 15, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE AFFECTED GUIDE WIRE WAS USED DURING A CORONARY ANGIOGRAPHY. WHILE THE AFFECTED WIRE WAS RETRACTED, THE STEERABLE, FLEXIBLE, X-RAY OPAQUE TIP BECAME DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALEO F GUIDEWIRE DQX BIOTRONIK GMBH AND CO. 115487 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention