Indications

Applies to 014 ViperCross™ Support Catheter:
The ViperCross™ support catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

Applies to 018/035 ViperCross™ Support Catheter:
The ViperCross™ support catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.
 

Contraindications

The ViperCross™ support catheter is contraindicated for high pressure injections and for use in the cerebral vasculature.
 

Warnings

The ViperCross™ support catheter is provided sterile for single use only. Reuse of a single-use device creates potential risk of patient or user infections. Contamination of the device may lead to illness or serious patient injury.

Do not exceed the maximum injection pressure of 300psi.

If an appropriate guidewire cannot be passed through the catheter, do not attempt to resolve the blockage by flushing the catheter in vivo. Catheter rupture and arterial injury could result. Identify and resolve the cause of the blockage or replace the catheter with a new one.

Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy. Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, damage to the catheter, or vessel perforation.

Do not advance the ViperCross™ support catheter ahead of the guidewire, as vessel perforation may result.
 

Precautions

Do not use the ViperCross™ support catheter if the packaging is damaged.

Inspect the catheter prior to use for any kinks. Do not use a damaged catheter. Vessel damage and/or inability to advance or withdraw the catheter may occur.

Care should be taken not to crush the catheter. Excessive tightening of a hemostatic valve onto the catheter shaft may result in damage to the wire lumen and difficulty while exchanging wires.

Flush the catheter lumen thoroughly with heparinized saline prior to use to prevent clot formation.

Take precautions to prevent or reduce clotting. Consider the use of systemic heparinization and heparinized sterile solution.

Exercise care while handling the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.

When the catheter is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the catheter without observing the resultant tip response.
 

Complications

The following complications are generally associated with catheterization procedures and may occur when using the ViperCross™ support catheter:

• local or systemic infection.
• air embolism
• intimal disruption
• arterial dissection
• perforation of the vessel wall
• vascular occlusion
• arterial thrombosis
• distal embolization of blood clots and plaque
• For 014 ViperCross™ support catheter only: myocardial infarction
• arterial spasm
• catheter fracture with tip separation and distal embolization