Cook Medical G09764 - SET, PNEUMO, INTRO TIP, W/HYDROPH COATING, EACH

Cook Medical G09764 - SET, PNEUMO, INTRO TIP, W/HYDROPH COATING, EACH

Intro-Tip Pneumothorax Set

Pneumothorax Sets consist of:

• 1 stainless steel needle
• 1 radiopaque catheter
• 1 Chest Drain Valve
• 1 polyvinylchloride connecting tube
• 1 plastic one-way stopcock

Features and Benefits

Used to treat simple spontaneous pneumothorax and tension pneumothorax.

• The catheter is introduced with a one-stick trocar technique.
• The Intro-Tip facilitates placement of the catheter and helps prevent the catheter from accordioning back over the trocar needle assembly when it encounters resistance during insertion.
• The hydrophilic coating on the distal 10 cm of the catheter, when activated, becomes very lubricious, reducing friction during catheter insertion.
• The connecting tube can be connected to a suction apparatus or to the Heimlich chest drain valve that is included in the set.

Components

• Catheter
• Stopcock
• Connecting tube
• Cook chest-drain valve

Intended Use

Pneumothorax Sets are intended for relief of simple spontaneous or iatrogenic pneumothorax and tension pneumothorax.

Contraindications

Pneumothorax Sets are not recommended for large fluid accumulation or hemothorax.

Precautions

• This product is intended for use by physicians trained and experienced in emergency treatment of pneumothorax. Standard techniques for placement of pneumothorax catheters in the pleural cavity should be employed.
• Activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline. For best results, maintain wetted condition of device during placement.
• The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.
• Lung puncture may result in an air embolus, which could lead to ischemia or infarction of major organs including the brain or cardiac system.

Instructions for Use

Device Assembly

• Assemble catheter, connecting tube, and stopcock.
• Attach Chest Drain Valve in direction indicated by arrow on valve.
  NOTE: Chest Drain Valve may be obviated if catheter is to be connected to a water seal suction apparatus or similar mechanical suction device. Do not connect catheter directly to wall suction.
• Ensure that the tip protector is removed from the device.
• If the needle is not already inserted, retract the stylet approximately 1 cm from the tip of the cannula and advance the cannula into the catheter through the sideport closest to the hub. Advance the cannula until its tip engages with the tip of the catheter.
• Advance the stylet fully and Luer lock it to the needle cannula.

Procedure

• Prep the access site with antiseptic and drape in a standard fashion.
  NOTE: The optimal insertion site of the pneumothorax catheter is the second anterior intercostal space either to the right or left of the sternum at the level of the angle of Louis, in the mid-clavicular line.
• After the introduction (through skin, subcutaneous tissue, muscle and fascia down to the parietal pleura) of local anesthesia, a 2 mm incision is made through the skin, subcutaneous tissue, muscle and fascia, but not through the parietal pleura.
• Insert the needle tip, with the catheter as its sheath, through the incision site into the pleural cavity at the level of the second anterior intercostal space just above the upper border of the third rib. Advance the needle and catheter with one hand while the other hand maintains pressure upon the stylet within the needle cannula.
• If a large pneumothorax is present (as determined by fluoroscopy or by roentgenograms) and there is certainty that the catheter and cannula are well within the pleural cavity, immediately push the catheter forward by sliding it over the needle cannula and into the pleural space.
  NOTE: If there is uncertainty as to whether the needle and catheter tip are well within the pleural cavity, as with a small pneumothorax, the inner needle stylet may be removed to determine whether there is a free flow of air. Once positioned within the pleural space, advance the catheter so that all catheter sideports are within the pleural space. As the catheter is advanced, the needle is slowly withdrawn.
• Monitor the catheter tip position fluoroscopically. The distal tip of the catheter should be positioned with the tip pointing toward the extreme apex of the pleural space.
• Attach the catheter to the chest with adhesive tape and skin suture.
• ALL CONNECTIONS MUST BE SECURE AND AIRTIGHT. Perform inspections of the catheter and connections regularly. If the Chest Drain Valve is removed, the stopcock should be turned to the off position to prevent re-entry of air into the pleural space.
• Obtain a chest roentgenogram within 24 to 48 hours before catheter removal.
• To remove catheter, have patient hold his/her breath in full inspiration. Withdraw the catheter and place petrolatum-impregnated gauze dressing over the chest wall opening; dress the gauze with adhesive tape.

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 package, inspect the product to ensure no damage has occurred.

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).