Cook Medical COKG55724 - TRAY, FUHRMAN, PLEURAL / PNEUMOPERICARDIAL, EACH

Cook Medical COKG55724 - TRAY, FUHRMAN, PLEURAL / PNEUMOPERICARDIAL, EACH

Fuhrman Pleural/Pneumopericardial Drainage Tray

The Fuhrman Pleural/Pneumopericardial Drainage Tray (PPD-) consists of pigtail catheter, access needle, dilator and wire guide. The set also includes a multipurpose tubing adapter. Refer to label for further information.

Intended Use

The Fuhrman Pleural/Pneumopericardial Drainage Tray (PPD-) is intended for evacuation of air from the pericardial sac or drainage of air or fluid from the pleural space. The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard Seldinger technique for placement of needles, wire guides, dilators and catheters should be employed.

Precautions

• Possible allergic reactions should be considered.
• The procedure may require two-dimensional echocardiographic guidance or fluoroscopic control to closely monitor the heart during placement into the pericardial space.
• A TFE-coated wire guide is recommended for a smoother catheter introduction.

Instructions for Use

• Prepare the chest using standard aseptic technique and infiltrate the insertion area with local anesthesia.
• If needed make a small incision with a scalpel.
• Direct the tip of the needle towards the desired catheter placement and insert the needle under the skin. If pericardium is the target, the metal shaft of the needle should be connected to the V lead of surface ECG and a stable tracing from this lead should be recorded.
• Gently advance the needle into the positive pressure area.
• Verify placement into the pleural or pericardial space by aspiration of air or fluid into syringe. Remove syringe once placement is verified.
• Introduce the wire guide and gently advance it into the selected cavity.
  NOTE: The wire guide should advance without impedance.
• Remove the needle, leaving the wire guide in place, then dilate with the supplied dilator to facilitate catheter introduction.
• Introduce the catheter over the wire guide.
  NOTE: The wire guide should always extend beyond the catheter tip.
• Advance the catheter into position. Remove the wire guide and attach the multipurpose adapter to the catheter.

Warnings

• The wire guide should always advance without impedance to avoid perforation of any surrounding structures.
• The wire guide should always extend beyond the catheter tip to avoid perforation of any surrounding structures.

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 to ensure no damage has occurred.