Cook Medical G10338 - CATHETER, EMERGENCY TRACH AIRWAY 6FR, EACH
Emergency Transtracheal Airway Catheter
The Emergency Transtracheal Aiway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed. The Enk Oxygen Flow Modulator allows manually contolled oxygen flow and is intended for emergency transtracheal catheter ventilation when conventional ventilation by mask or endotracheal tube cannot be performed.
Used with emergency transtrachael catheter ventilation when conventional ventilation by mask or endotracheal tube cannot be performed.
Intended Use
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.
The Enk Oxygen Flow Modulator allows manually controlled oxygen flow and is intended for emergency transtracheal catheter ventilation when conventional ventilation by mask or endotracheal tube cannot be performed.
| Order Number | Reference Part Number | Catheter (Fr) | Catheter Length (cm) | Catheter ID (mm) | Needle gage |
| G10338 | C-DTJV-6.0-5.0-BTT | 6 | 5 | 2 | 15 |
Features and Benefits
- Allows manually controlled oxygen flow.
- Kink-resistant, wire-reinforced catheter to prevent collapse once placed.
- Includes Emergency Transtracheal Airway Catheter tubing for attachment to oxygen source and Enk flow modulator.
Components
- Catheter needle
- Syringe
- Enk Oxygen Flow Modulator
- Emergency Transtracheal Airway
- Catheter tubing
Clinical Speciality
- Critical Care Medicine
- Emergency Medicine
Potential Adverse Events
- Aspiration
- Barotrauma
- Bleeding
- Catheter dislodgement
- Hematoma
- Pneumomediastinum
- Subcutaneous emphysema
- Tracheoesophageal fistula
Device Characteristics
| What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): | No |
| Device labeled as "Not made with natural rubber latex": | No |
| For Single-Use: | Yes |
| Prescription Use (Rx): | Yes |
| Over the Counter (OTC): | No |
| Kit: | No |
| Combination Product: | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |
Instructions for Use
Emergency Transtracheal Airway Catheter
- Prep the patients anterior neck.
- Identify the cricothyroid membrane between the cricoid and thyroid cartilages, and stabilize the trachea with the thumb and index finger.
- Cannulate the trachea with the catheter tip facing caudad. A loss of resistance is felt when the trachea is entered.
- Aspirate air into a water-filled 5 cc syringe to confirm catheter position within the tracheal lumen.
- Remove the needle and advance the catheter caudad. Aspirate again to confirm position.
- Connect the catheter to oxygen source, as directed in the following section.
Enk Oxygen Flow Modulator
- Connect the oxygen flow modulator to the tubing of an oxygen source.
- Attach the Luer lock of the oxygen flow modulator to the transtracheal airway catheter.
NOTE: The pressure of the oxygen source must be high enough to create a pulsed gas flow through the flow modulator and the attached transtracheal catheter. Oxygen pressure of a common wall outlet (50 psi or 3.5 bar) is adequate. - Select an oxygen flow of at least 15, and up to 30, liters/minute.
- Occlude and release all openings in the tubing of the oxygen flow modulator intermittently by using the thumb and index finger (e.g., 100 cycles per minute).
CAUTION: Continuous closure of the openings may cause barotrauma. - Observe the chest and the upper abdomen for slight outward and inward movements to confirm pulmonary inflation and exhalation.
NOTE: The pulsed oxygen flow should result in slight outward and inward movements of the chest and/or upper abdomen. In case of upper airway obstruction, gas discharge from the patients lungs through the released openings of the oxygen flow modulator will require more time.
How Supplied
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from the package, inspect the product to ensure no damage has occurred.
