This low profile, high pressure, 0.018” guidewire compatible balloon catheter is designed to be inserted through a 4 French introducer sheath for dilatations of small vessels.
Features and Benefits
Short balloon tapers and distal tip for optimal trackability and crossing of tight lesions.
Rapid inflation and deflation times to maximize reperfusion and minimize procedure time.
Ultra low profile for exceptional deliverability through small sheath sizes.
Safety informations
INDICATIONS:
Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.
WARNINGS:
CAUTION: 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.
In PTA, the dilated balloon should not markedly exceed the diameter of the artery lying just proximal to the stenosis.
Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate the balloon.
Do not advance the guidewire, balloon dilatation 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.
Do not remove the guidewire from the catheter at any time during the procedure.
This device is intended for single use only. Do not resterilize and/or reuse it, as this can potentially result in compromised device performance and increased risk of cross-contamination.
PRECAUTIONS:
Dilatation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
Guidewires are delicate instruments. 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 aspiration before proceeding to avoid air introduction into the system.
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, then the balloon, guidewire, and the sheath should be removed together 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.
Before removing catheter from sheath it is very important that the balloon is completely deflated.
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
Potential adverse events
Potential complications related to the introduction of the catheter into the body include, but are not limited to, the following: infection, air embolism, and hematoma formation.
Potential balloon separation following balloon rupture or abuse and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.
Complications associated with PTA include, but are not limited to : clot formation and embolism, nerve damage, vascular perforation requiring surgical repair, damage to the vascular intima, cerebral accident, cardiac arrhythmias, myocardial infarction, or death. For specifics, refer to: Fellows, K. et al.: Acute Complications of Catheter therapy for Congenital Heart Disease,