INDICATIONS
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
DESCRIPTION The NuMED Balloon in Balloon (BIB) Catheter is a triaxial design catheter. Two lumens are used to inflate the balloons while one lumen is for tracking over a guidewire. The radiopaque platinum marker(s) are placed beneath the 'working area' of the balloon. The inner balloon is ½ of the outer balloon diameter and 1 cm shorter. Each balloon inflates to the stated diameter and length at a specific pressure. The balloon size is ± 10% at rated burst pressure (RBP). The RBP is different for each size. Check the package label for the RBP. It is important that the balloon not be inflated beyond the RBP. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of opening a vascular channel using a balloon expandable intravascular stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent in place while the outer balloon is inflated. The outer balloon is then inflated securing the stent against the vessel wall.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas. Sterile and non-pyrogenic if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.
WARNING
• Do not exceed the RBP. An inflation device with pressure gauge is recommended to monitor pressure. Pressure in excess of the RBP can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.
• Confirm that the distal end of the introducing sheath is at least 2.5cm back from the most proximal image band before inflating the outer balloon. Failure to do so may stretch the outer tubing and severely hinder balloon deflation.
• Use two appropriate size inflation devices with pressure gauges for inflation.
• Do not advance the guidewire, balloon catheter, or any other component if resistance is met, without first determining the cause and taking remedial action.
• This catheter is not recommended for pressure measurement or fluid injection.
PRECAUTIONS
• Use of an inflation device with pressure gauge is highly recommended during this procedure.
• The stent is rigid and may make negotiation through vessels difficult.
• Dilatation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
• Guidewires are delicate devices. Care should be exercised while handling to help prevent the possibility of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and by aspiration before proceeding to avoid air introduction into the system.
• The inflation diameter of the balloon used during stent delivery should approximate the diameter of the obstructive vessel and the intended implant site.
• Under no circumstances should any portion of the catheter system be advanced against resistance. The cause of the resistance should be identified with fluoroscopy and action taken to remedy the problem.
• If resistance is felt upon removal, the balloon, guidewire, and sheath should be removed as a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.
• Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter.
