BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 2535942 · Received April 11, 2012

    Report

    Report Number
    1820334-2012-00195
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 14, 2012
    Manufacturer
    COOK, INC.
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SURGICAL PROCEDURE IS NOT LISTED IN THE INSTRUCTIONS FOR USE. ADDITIONAL SURGICAL PROCEDURE IS NOT LISTED IN THE INSTRUCTIONS FOR USE. PRODUCT WAS NOT RETURNED TO ASSIST IN OUR INVESTIGATION. APPROPRIATE DESIGN CONTROLS HAVE BEEN COMPLETED. PER SPECIFICATION, "FOR INNER CANNULA AND OBTURATOR, MEASURE BOXED DIMENSIONS AND CONFIRM OVERALL SURFACE IS CLEAN AND FREE FROM DAMAGE OR IMPERFECTIONS AND THAT DISTAL TIP IS SMOOTH WITH NO ROUGH EDGES." THE INSTRUCTIONS FOR USE (IFU) DETAILS PROPER USAGE AND PLACEMENT TECHNIQUES AS WELL AS THE NECESSARY WARNINGS AND PRECAUTIONS. THE IFU CONTAINS THE FOLLOWING WARNING. "ANATOMIC ANOMALIES MAY MAKE THE PROCEDURE DIFFICULT TO PERFORM. THE PRESENCE OF ANOMALOUS BLOOD VESSELS MAY CAUSE EXCESSIVE BLEEDING DURING THE PROCEDURE." QUALITY CONTROL MEASURES THE LENGTH OF THE INNER CANNULA AND OBTURATOR AND CONFIRMS THE OVERALL SURFACE IS CLEAN AND FREE FROM DAMAGE OR IMPERFECTIONS AND THAT THE DISTAL TIP IS SMOOTH WITH NO ROUGH EDGES. WITHOUT THE ACTUAL COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE LED TO THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. PER THE CONCLUSIONS OF QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER MITIGATING ACTIONS ARE NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    INFO WAS PROVIDED THAT THE PHYSICIAN CONTACTED THE REP, ADVISING THAT THE PRIMARY PROCEDURE WENT FINE; ALTHOUGH A DECISION WAS MADE TO CHANGE THE FIRST TUBE (1820334-2011-00194) WITH A SECOND ONE VERSATUBE 9MM (1820334-2012-00195). THIS WAS DONE AS THE FIRST TUBE WAS TOO SHORT, ALWAYS UNDER FIBER OPTIC SCOPE, ALTHOUGH THAT PROCEDURE WENT VERY WELL. HOWEVER, AFTER 4 HOURS, THE PT SUDDENLY SUFFERED COMPLICATIONS AS THE TRACHEA WAS BLEEDING DUE TO IT BEING DAMAGED. IT WAS NECESSARY TO CALL A SURGEON TO REPAIR IT IN AN OPERATING THEATRE. THE INTERVENTION TOOK ALMOST 3 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET KCG DILATOR, TRACHEAL KCG COOK, INC. NA 2638210

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention