Rubicon™ Control Support Catheter

Indented use/indication for use

The Rubicon Control Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires and provide a conduit for the delivery of saline or contrast solutions. 

Contraindications

None known

Warnings 

• The infusion pressure with this catheter should not exceed 2068 kPa (300 psi). Infusion pressure in excess of this maximum may result in catheter rupture, possibly resulting in patient injury.
• If the catheter is used for infusion, reference Flow Rate Table (Table 1 from the IFU) and ensure infusion pressure does not exceed the recommendations.
• The catheter is designed and intended for intravascular use only.
• These catheters are not designed for use in the coronary arteries or the neurovasculature. Any use for procedures other than those indicated in the instructions is not recommended.

Precautions

• Carefully inspect the catheter prior to use to verify the size and shape are suitable for the specific procedure and that it has not been damaged during shipping or handling.
  

Adverse events

Potential adverse events which may be associated with the use of a support catheter when used as indicated include, but are not limited to: 

• Allergic reaction (contrast, device & other) 
• Death
• Embolism (air, device, plaque, thrombus, tissue, or other)
• Hematoma
• Hemorrhage
• Infection/Sepsis
• Ischemia
• Need for additional intervention or surgery
• Pain
• Thrombosis/Thrombus
• Vasospasm 
• Vessel Occlusion
•  Vessel Trauma (AV fistula, dissection, perforation, pseudoaneurysm, rupture or injury)