BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1080761 · Received July 22, 2008

    Report

    Report Number
    9616099-2008-01814
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K972978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRITE TIP GUIDING CATHETER HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AS OF TO DATE. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A VISTA BRITE TIP 7F .078 VERTEBRAL 90CM GUIDING CATHETER WAS ADVANCED THROUGH AN 11FRENCH SHEATH. AN EN SNARE DEVICE WAS PLACED THROUGH THE VISTA BRITE TIP AND PLACED IN THE RIGHT INTERNAL JUGULAR VEIN FOR RETRIEVAL OF A GUNTHER TUPLIP VENA CAVA FILTER. WHILE ATTEMPTING TO SNARE THE FILTER, A RADIOPAQUE OBJECT OF THE GUIDE CATHETER SEPARATED AND WAS OBSERVED "FREE FLOATING" IN THE VENA CAVA. THIS OBJECT, WHICH IS THE DISTAL TIP OF THE GUIDING CATHETER, WAS RETRIEVED FROM THE PT ALONG WITH THE VENA CAVA FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS ENDO GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 50905036

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SNARING DEVICE.| 11FRENCH SHEATH