BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETERS EF

    MDR report key: 705621 · Received April 27, 2006

    Report

    Report Number
    1820334-2006-00086
    Event Type
    Injury
    Date Received
    April 27, 2006
    Date of Event
    March 22, 2006
    Report Date
    March 28, 2006
    Manufacturer
    COOK, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE EXCHANGING A 41 ET TUBE FOR A 39 ET TUBE AT THE END OF A LEAF LOWER LOBECTOMY PROCEDURE, RESISTANCE WAS ENCOUNTERED. THE CAE WAS PULLED FIRMLY AND REMOVED WITH THE TUBE. A VISUAL INSPECTION OF THE DISTAL END OF THE CAE FOUND THE TIP APPEARED TO BE MISSING. UPON VISUALIZATION OF THE TRACHEAL LUMEN, USING A 4MM FLEXIBLE BRONCHOSCOPE, A PIECE OF THE CAE, APPROX 2.5CM LONG WAS SEEN PROXIMALLY TO THE BRONCHIAL LUMEN OF THE DLT. FURTER VISUALIZATION REVEALED THE PIECE HAD BEEN ROTATED 180 DEGREES. UTILIZING SUCTION, RIGID AND FLEXIBLE BRONCHOSCOPY AND VARIOUS GRASPERS AND FORCEPS, THE PIECE WAS REMOVED TWO HOURS LATER AND THE OPERATION PROCEEDED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK AIRWAY EXCHANGE CATHETERS EF SPECIAL SET BTR COOK, INC. NA 1521788

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention