BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHECK-FLO PERFORMER INTRODUCER SET

    MDR report key: 358061 · Received October 24, 2001

    Report

    Report Number
    1820334-2001-00087
    Event Type
    Other
    Date Received
    October 24, 2001
    Date of Event
    September 28, 2001
    Report Date
    September 28, 2001
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE SHEATH WAS BEING UTILIZED DURING PLACEMENT OF ANOTHER MANUFACTURER'S ENDOSTENT. DURING ADVANCEMENT OF THE LOADER INTO THE SHEATH, THE VALVE DISLODGED AND WENT INTO THE SHEATH BODY. BACK FLOW OF BLOOD WAS NOTED AND IT WAS NOTED THE VALVE HAD MOVED FORWARD. THE DEVICE WAS REMOVED AND THE VALVE WAS NOTED TO BE INSIDE THE SHEATH BODY. THE PATIENT HAS SUSTAINED NO ADVERSE EFFECT FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47692 CHECK-FLO PERFORMER INTRODUCER SET SHEATH SET DYB COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other