BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 5750508 · Received June 27, 2016

    Report

    Report Number
    1820334-2016-00509
    Event Type
    Injury
    Date Received
    June 27, 2016
    Report Date
    May 31, 2016
    Manufacturer
    COOK INC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME) LNZ. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PROCODE: LNZ. (B)(4). INVESTIGATION - EVALUATION A REVIEW OF THE SPECIFICATIONS AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE DEVICE IS MANUFACTURED TO SPECIFICATIONS: "CONFIRM OVERALL SURFACE OF CATHETER IS CLEAN AND FREE OF EXCESSIVE DENTS, SCRATCHES OR BUMPS. MARKERS MUST BE SMOOTH. ¿INSPECTION METHOD: VISUALLY EXAMINE AND FEEL..¿ THE LOT NUMBER IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    UPON REMOVING A 19 FR. CATHETER DURING A THORACOTOMY, RESISTANCE WAS FELT. THE CATHETER WAS ROTATED AND THE DEVICE WAS REMOVED EASILY. IT WAS NOTED THAT THE OUTER LAYER HAD BUCKLED AT A PORTION, AND A SMALL DEFECT WAS NOTED. A SMALL 2-3MM X 1-2MM YELLOW OUTER LAYER IN THE PATIENT'S TRACHEA WAS REMOVED BY USING A BRONCHOSCOPE. THE REPORTER STATES THIS DEVICE MAY HAVE BEEN TOO LARGE FOR PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    UPON REMOVING A 19 FR. CATHETER DURING A THORACOTOMY, RESISTANCE WAS FELT. THE CATHETER WAS ROTATED AND THE DEVICE WAS REMOVED EASILY. IT WAS NOTED THAT THE OUTER LAYER HAD BUCKLED AT A PORTION, AND A SMALL DEFECT WAS NOTED. A SMALL 2-3MM X 1-2MM YELLOW OUTER LAYER IN THE PATIENT'S TRACHEA WAS REMOVED BY USING A BRONCHOSCOPE. THE REPORTER STATES THIS DEVICE MAY HAVE BEEN TOO LARGE FOR PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405569 COOK AIRWAY EXCHANGE CATHETER DQY COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention