COOK Medical CODA Instrucciones De Uso página 2

ENGLISH
CODA® AND CODA® LP BALLOON CATHETERS
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Coda and Coda LP Balloon Catheters each consist of two independent
lumens. The "Distal" lumen extends the length of the catheter and is used for
placement over wire guides. The "Balloon" lumen is used to inflate and deflate
the balloon.
The balloon is manufactured from a compliant polyurethane material.
Particular care should be taken in handling the balloon to prevent damage.
The balloon will inflate to the indicated size parameters when utilizing proper
volume recommendations.
Radiopaque bands are placed on the balloon catheter to assist with
positioning of the device under fluoroscopy.
INTENDED USE
The Coda and Coda LP Balloon Catheters are intended for temporary
occlusion of large vessels, or to expand vascular prostheses.
CONTRAINDICATIONS
None known
WARNINGS
• Do not exceed maximum inflation volume. Adhere to balloon inflation
parameters as shown in Figs. 1 and 2. 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 46 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 46 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.
POTENTIAL ADVERSE EVENTS
• Vessel dissection, perforation, rupture or injury
• Occlusion at some locations may cause arrhythmia
• Drug reactions
• Infection and pain at insertion site
• Arterial thrombosis and/or embolism
• Death
PRODUCT RECOMMENDATIONS
Wire Guide Selection
The catheter is compatible with .035 inch wire guides.
Introducer Sheath Selection
For introduction, it is recommended to use a minimum 14.0 French
introducer sheath for the 10.0 French Coda Balloon Catheter and a
minimum 12.0 French introducer sheath for the 9.0 French Coda LP
Balloon Catheter.
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