Rubicon™ Support Catheter

Indications, Safety and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions

Rubicon 14 18 4F 35 5F Support Catheter

INTENDED USE/INDICATIONS FOR USE

The Rubicon 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 catheter is designed and intended for intravascular use only.
  • This catheter is designed and intended for one time use only. Do not re-sterilize and/or reuse.
  • This catheter should only be used by physicians qualified to perform percutaneous, vascular interventions.
  • 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

  • Support Catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications and risks associated with support catheters is necessary before performing this procedure.
  • Precautions to prevent or reduce clotting should be taken when any catheter is used. Use of systemic heparinization should be considered.

ADVERSE EVENTS

Vascular catheterization and/or vascular interventions may result in complications including but not limited to:

  • Access site pain
  • Allergic reaction (drug, contrast, device & other) and neurological reactions
  • Death
  • Hemorrhage or hematoma
  • Impaired blood flow due to thrombosis, embolism, or vasospasm that could lead to tissue infarction, limb amputation, and other thrombo-embolic organ damage such as renal infarction
  • Infection/Sepsis
  • Vessel injury (dissection, perforation, trauma & rupture)
  • Vasospasm

Rubicon 14 4F Support Catheter

INTENDED USE/INDICATIONS FOR USE

The Rubicon 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 catheter is designed and intended for intravascular use only.
  • This catheter is designed and intended for one time use only. Do not re-sterilize and/or reuse.
  • This catheter should only be used by physicians qualified to perform percutaneous, vascular interventions.
  • 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

  • Support Catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications and risks associated with support catheters is necessary before performing this procedure.
  • Precautions to prevent or reduce clotting should be taken when any catheter is used. Use of systemic heparinization should be considered.

ADVERSE EVENTS

Vascular catheterization and/or vascular interventions may result in complications including but not limited to:

  • Access site pain
  • Allergic reaction (drug, contrast, device & other) and neurological reactions
  • Death
  • Hemorrhage or hematoma
  • Impaired blood flow due to thrombosis, embolism, or vasospasm that could lead to tissue infarction, limb amputation, and other thrombo-embolic organ damage such as renal infarction
  • Infection/Sepsis
  • Vessel injury (dissection, perforation, trauma & rupture)
  • Vasospasm
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