BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCOOP ADULT CATHETER, C-9-2

    MDR report key: 2489927 · Received January 25, 2012

    Report

    Report Number
    1721097-2012-00001
    Event Type
    Death
    Date Received
    January 25, 2012
    Date of Event
    November 18, 2011
    Report Date
    December 24, 2011
    Manufacturer
    TRANSTRACHEAL SYSTEMS INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS, BOTH BY PHONE AND BY EMAIL, HAVE BEEN MADE TO OBTAIN PERTINENT ADDITIONAL INFO, HOWEVER, THE HOSPITAL HAS BEEN UNRESPONSIVE.

    Description of Event or Problem · 1

    PT HAD UNDERGONE MODIFIED SELDINGER PROCEDURE (T-9) ON OR ABOUT (B)(6) 2011 AND HAD THE SCOOP C-9-2 ADULT CATHETER PLACED AT SOME TIME PRIOR TO (B)(6) 2011. ON (B)(6) 2011, PT COMPLAINED OF SOME TIGHTNESS AND SWELLING IN HIS NECK AND FACE WHICH THE HOSPITAL FELT WAS CAUSED BY THE BEAD CHAIN NECKLACE SECURING THE SCOOP CATHETER IN PLACE. THE HOSPITAL REPLACED THE BEAD CHAIN NECKLACE WITH A CLOTH COLLAR. ON THE MORNING OF (B)(6) 2011, THE PT DESATURATED, ARRESTED AND DIED. THE HOSPITAL REPORTED THAT NO AUTOPSY WAS PERFORMED BUT ALLEGED THAT THE CATHETER HAD MIGRATED TO THE SOFT TISSUE PLANES RESULTING IN PNEUMOMEDIASTINUM AND GENERALIZED EMPHYSEMA. SEVERAL UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO CONTACT THE PROPER OFFICIAL AT THE HOSPITAL TO OBTAIN ADD¿L INFO THAT IS PERTINENT TO THIS ALLEGED INCIDENT, HOWEVER, THE HOSPITAL¿S REPORT STATED THAT THEY FOLLOWED "MFR¿S RECOMMENDATIONS." AS PUBLISHED IN TRANSTRACHEAL SYSTEMS APPROVED "CLINICIANS GUIDE FOR THE MODIFIED SELDINGER INSERTION TECHNIQUE," PROVIDED IN ALL PROCEDURE KITS PURCHASED AND SHIPPED, SPECIFIC INSTRUCTIONS ARE DOCUMENTED TO SAFE GUARD AND ELIMINATE THE RISK AND OCCURRENCE OF PNEUMOMEDIASTINUM AND THE ALLEGED MIGRATION OF SCOOP CATHETERS. FOLLOWING ARE EXCERPTS FROM THE "CLINICIANS GUIDE FOR THE MODIFIED SELDINGER INSERTION TECHNIQUE" AND CAN BE ACCESSED ON TRANSTRACHEAL SYSTEMS WEB SITE, WW.TTO2.COM: POSTPROCEDURE ROUTINE. AT THE CONCLUSION OF THE TRANSTRACHEAL PROCEDURE, THE PT IS TAKEN TO THE RADIOLOGY SUITE FOR A POSTEROANTERIOR AND LATERAL CHEST X-RAY. THIS SHOULD DOCUMENT THE ABSENCE OF EXTRAVASATED AIR (SUBCUTANEOUS EMPHYSEMA, PNEUMOMEDIASTINUM AND PNEUMOTHORAX) AND CONFIRM THE INTRATRACHEAL LOCATION OF THE RADIOPAQUE STENT. THE RELATIONSHIP OF THE TIP OF THE STENT TO THE CARINA IS NOTED. IF THE TIP OF THE STENT IS CLOSER THAN 1 CM TO THE CARINA, A SHORTER CATHETER SHOULD BE OBTAINED BEFORE TRANSTRACHEAL OXYGEN IS STARTED ONE WEEK LATER. FOUR SERIAL ERRORS WOULD HAVE TO BE MADE TO GET THE STENT OUTSIDE THE TRACHEA. FIRST, AIR WOULD NOT BE ASPIRATED AS THE NEEDLE IS INSERTED. SECOND, THE WIRE GUIDE WOULD NOT FALL FREELY INTO THE TRACHEA. THIRD, AIR WOULD NOT BE REGURGITATED OUT THROUGH THE LUMEN OF THE STENT. AND FOURTH, THE POSTPROCEDURE CHEST X-RAYS WOULD SHOW THE RADIOPAQUE STENT OUTSIDE THE TRACHEA. NO INJURY WOULD RESULT IF DURING ANY OF THESE STEPS THE STENT IS RECOGNIZED TO BE OUTSIDE THE TRACHEA AND IS REMOVED. A LOW RATE EXTRAVASATED AIR (SUBCUTANEOUS EMPHYSEMA, PNEUMOMEDIASTINUM AND PNEUMOTHORAX) RESULTS FROM SEVERAL FACTORS. THE HIGHEST RATE HAS BEEN OBSERVED WITH OTHER SYSTEMS WHEN A FUNCTIONING CATHETER IS INSERTED AT THE TIME OF THE PROCEDURE AND IMMEDIATELY CONNECTED TO OXYGEN. THE ADDITIVE TICKLE OF THE FOREIGN BODY AND FLOW OF OXYGEN CAUSE BRISK COUGHING. COUGHING WITHOUT A SKIN INCISION AND WITH THE LUMEN OF THE CATHETER OBSTRUCTED ALLOWS GAS TO PASS AROUND THE CATHETER INTO THE TISSUES. THE STENT ENCOURAGES GAS TO PASS THROUGH THE LUMEN OR AROUND THE STENT TO THE SURFACE VIA AN OPEN INCISION AND NONOCCLUSIVE DRESSING. THE ABSENCE OF GAS FLOW MINIMIZES COUGHING, BECAUSE THE TRACHEA RAPIDLY ACCOMMODATES TO THE PRESENCE OF JUST THE FOREIGN BODY. SYSTEMIC ANTITUSSIVES AND TOPICAL LIDOCAINE FURTHER SUPPRESS COUGHING. DURING THE WEEK FOLLOWING THE TRANSTRACHEAL PROCEDURE, PTS CONTINUE TO RECEIVE SUPPLEMENTAL OXYGEN VIA NASAL PRONGS. PTS ARE SPECIFICALLY INSTRUCTED NOT TO CONNECT OXYGEN TO THE STENT. THE NONOCCLUSIVE DRESSING MAY BE REMOVED AFTER THE FIRST DAY, BUT THE TRACT IS KEPT CLEAN AND DRY. THE TRACT IS CLEANED TWICE DAILY WITH A COTTON-TIPPED APPLICATOR AND 3% HYDROGEN PEROXIDE. REGURGITATION OF AIR THROUGH THE STENT USUALLY STOPS AFTER 2 OR 3 DAYS WHEN THE LUMEN BECOMES BLOCKED BY INSPISSATED SECRETIONS. THE STENT WEEK ALLOWS THE PT TO ADAPT TO THE FOREIGN BODY BEFORE THE ADDITIONAL TICKLE OF GAS IS INTRODUCED. THE STENT WEEK IS TYPICALLY SMOOTH, BUT A PHONE CALL THE AFTERNOON OF THE PROCEDURE AND THE DAY AFTER THE PROCEDURE IS MADE TO CONFIRM THAT THE PT IS NOT EXPERIENCING PROBLEMS. THE EXCHANGE OF THE STENT FOR A FUNCTIONING SCOOP CATHETER IS ACCOMPLISHED WITH THE PT SEATED IN THE PROCEDURE CHAIR WITH A HEADREST. NASAL PRONGS ARE REARRANGED TO ARRIVE FROM BEHIND SO AS TO FREE ANTERIOR NECK. THE SUPPLIES SAVED IN THE PT¿S STORAGE ENVELOPE ARE SET OUT ON A STERILE TOWEL ON A SMALL MAYO STAND. A SCOOP CATHETER IS OPENED, AND A SMALL AMOUNT OF STERILE WATER SOLUBLE JELLY IS PLACED ON THE TIP OF THE CATHETER. THE PREVIOUSLY-CUSTOMIZED NECKLACE IS PASSED THROUGH THE EYELETS OF THE CATHETER. THE ATRAUMATIC END OF THE WIRE GUIDE IS PASSED THROUGH THE STENT UP TO THE BLACK REFERENCE MARK TO CLEAR DRIED SECRETIONS. FACIAL TISSUE IS GIVEN TO THE PT WHO IS FOREWARNED ABOUT THE INCIPIENT COUGH, BAD TASTE AND GLOBUS SENSATION WHICH IS CAUSED BY TRANSTRACHEAL INJECTION OF LOCAL ANESTHETIC. ABOUT 2CC OF 1% PLAIN LIDOCAINE IS DRAWN INTO A LUER TAPER SYRINGE THEN QUICKLY INJECTED THROUGH THE STENT. THE CRUSTS ABOUT THE STENT ARE CLEANED WITH COTTON-TIPPED APPLICATORS DIPPED IN 3% HYDROGEN PEROXIDE. THE SUTURES ARE THEN CUT WITH THE SCISSORS SAVED FROM THE PRIOR WEEK. THE SCOOP WIRE GUIDE IS INSERTED TO THE BLACK REFERENCE MARK, AND THE STENT IS WITHDRAWN. AN ASSISTANT HOLDS THE BLACK REFERENCE MARK AT THE LEVEL OF THE SKIN TO PREVENT INADVERTENT REMOVAL OF THE WIRE. THE SCOOP CATHETER WITH THE PRETHREADED NECKLACE IS THEN PASSED OVER THE WIRE GUIDE AND TWIRLED 360 DEGREES INTO THE TRACT. WHEN THE FLANGE COMES TO REST AGAINST THE SKIN, THE WIRE GUIDE IS REMOVED AND THE NECKLACE CLASP CONNECTED. A PULSE OXIMETER IS PLACED ON THE PT¿S FINGER, AND THE HOSE IS CONNECTED TO THE CATHETER VIA THE LUER TAPER CONNECTOR. THE OXYGEN FLOW RATE IS INITIALLY TURNED DOWN TO HALF OF THE NASAL PRONG FLOW RATE, AND THE SCOOP OXYGEN HOSE IS CONNECTED TO THE SOURCE. THE NASAL PRONGS ARE THEN REMOVED. THE PT IS TITRATED ON TRANSTRACHEAL OXYGEN TO AN SAO2> 90% (USUALLY 91-92%), AND ADEQUACY OF OXYGENATION AND VENTILATION ARE CONFIRMED WITH AN ARTERIAL BLOOD GAS PER PHYSICIAN ORDER. THE PT IS THEN WALKED WITH HIS/HER OWN PORTABLE SOURCE, AND AN ACTIVITY FLOW RATE IS PRESCRIBED. ALL TTO PTS SHOULD HAVE THREE FLOW RATES DOCUMENTED: A RESTING TTO RATE, AN ACTIVITY TTO RATE, AND A NASAL PRONG FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOOP ADULT CATHETER, C-9-2 SAME BTO TRANSTRACHEAL SYSTEMS INC. C-9-2 2071

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death