BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHECK-FLO II INTRODUCER SET

    MDR report key: 276939 · Received May 9, 2000

    Report

    Report Number
    1820334-2000-00045
    Event Type
    Other
    Date Received
    May 9, 2000
    Date of Event
    April 7, 2000
    Report Date
    April 10, 2000
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS BEING UTILIZED DURING A "TIPS" PROCEDURE. TIP OF SHEATH WAS IN RIGHT ATRIUM AND UPON ADVANCEMENT OF A 5 FRENCH CATHETER, THE RADIOPAQUE BAND CAME OFF. THE BAND WENT INTO THE DISTAL PULMONARY TREE. NO ATTEMPT WAS MADE TO RETRIEVE. PT HAS NOT SUSTAINED ANY ADVERSE EFFECT FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK-FLO II INTRODUCER SET SHEATH SET DYB COOK INCORPORATED NA 965303

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other