Renegade™ Microcatheters, kits and systems indications, safety, and warnings

The Renegade STC 18 Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

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Carefully read all instructions prior to use of this product. Observe all warnings and precautions, failure to do so may result in complications.

• Contents supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
• Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in separation of the microcatheter or guidewire tip, damage to the microcatheter or guidewire tip, or vessel perforation.
• The infusion pressure with this microcatheter should not exceed 6895 kPa (1000 psi). Infusion pressure in excess of this maximum may result in microcatheter rupture, possibly resulting in patient injury. If flow through the microcatheter becomes restricted, do not attempt to clear the microcatheter lumen by infusion. The static pressure with this microcatheter should not exceed 2070 kPa (300 psi). Static pressure in excess of this maximum may result in microcatheter rupture, possibly resulting in patient injury. Identify and resolve the cause of the blockage or replace the microcatheter with a new microcatheter before resuming infusion.
• The Renegade STC 18 Microcatheter is not intended for use in the coronary vasculature or the neurovasculature.
• The safety and effectiveness of the devices has not been established or is unknown in vascular regions other than those specifically indicated.

• This device should be used only by physicians experienced in peripheral endovascular techniques and procedures.
• Prior to use, carefully examine the unit to verify that the sterile package or product has not been damaged during shipment.
• Prior to a procedure, all equipment to be used for the procedure should be carefully examined to verify proper function and integrity. Do not use if product is damaged.
• Inspect the microcatheter prior to use for any surface irregularities, bends, kinks or other damages. Any catheter damage may decrease the desired performance characteristics.
• Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking. Do not use a microcatheter or guidewire that has been damaged.
• When the microcatheter is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the microcatheter without observing the resultant tip response.
• Extensive guidewire manipulation during lengthy procedures and the use of embolic agents may require the exchange of new microcatheters in place of the used microcatheters.
• Advancing the microcatheter into subselective vasculature may interfere with the microcatheter removal and may cause harm to the vessel.
• Excessive tightening of a RHV onto the microcatheter shaft may result in damage to the microcatheter.
• If other interventional devices are used with the Renegade STC 18, then refer to that product labeling for intended use, contraindications and potential complications associated with the use of that interventional device.
• Do not use the device after the use by date.
• It is recommended that a continuous flow of appropriate flush solution be maintained between the guiding catheter and the microcatheter and between the microcatheter and the guidewire during the procedure. Flushing prevents contrast crystal formation and/or thrombosis on the guidewire and in the catheter lumen.

Potential Adverse Events which may be associated with the use of a microcatheter or interventional procedure include, but are not limited to:

• Allergic reaction (device, contrast, medication, other)
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA), transient ischemic attack (TIA)
• Death
• Embolism (air, device, plaque, other)
• Hematoma
• Infection/sepsis
• Need for additional intervention
• Thrombus/thrombosis
• Vasospasm
• Vessel occlusion
• Vessel trauma (dissection, perforation, rupture, injury, pseudoaneurysm, etc.)