WARNINGS
- Do not exceed maximum inflation volume. Adhere to balloon inflation parameters as shown in Fig.
Over-inflation of balloon may result in:
• Damage to vessel wall and/or vessel rupture.
• Rupture of balloon.
• Do not use a pressure inflation device for balloon inflation.
• Do not use a power injector for injection of contrast medium through Distal lumen. Rupture may
occur.
• The Coda 40 mm balloon catheter should not be used for dilation of vascular prostheses in iliac
or other non-aortic vessels. Injury to vessel wall and/or rupture may occur.
• The Coda 40 mm balloon catheter should not be used in vessels less than 24 mm in diameter.
• When used to expand a vascular prosthesis, the balloon radiopaque markers should remain within
the prosthesis.
• Not for use as a valvuloplasty balloon catheter.
PRECAUTIONS
- This product is intended for use by physicians trained and experienced in diagnostic and
interventional techniques. Standard techniques for placement of vascular access sheaths,
angiographic catheters and wire guides should be employed.
- Prolonged duration of occlusion may cause paralysis or damage to vital organs.
- The balloon is constructed of heat-sensitive material. Do not heat or attempt to shape the catheter tip.
- Always manipulate catheter using fluoroscopic control.
- Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate balloon.
- Do not use after labeled expiration date.
- Always monitor balloon inflation using fluoroscopic control.
