Direxion™ and Direxion HI-FLO™ Torqueable Microcatheters indications, safety, and warnings

The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature.

The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

None known.

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 resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in damage or separation of the microcatheter or guidewire tip, or vessel perforation.
• The Infusion pressure should not exceed 1200 psi (8274 kPa) with Direxion HI-FLO and 800 psi (5515 kPa) with Direxion. 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 300 psi (2070 kPa). 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 Direxion Microcatheter family is not intended for use in the coronary vasculature or neurovasculature.
• The Direxion HI-FLO Microcatheter is not designed for the delivery of embolic coils.
• Use of excessive force to manipulate the microcatheter against resistance can cause a fracture in the nitinol shaft of the microcatheter. Take care not to over-torque the microcatheter, and to relieve any tension before withdrawal by rotating the microcatheter in the opposite direction.
• The safety and effectiveness of the devices has not been established or is unknown in vascular regions other than those specifically indicated.
• Do not leave the guidewire in a prolapsed condition, as damage to the guidewire may occur.

• These devices should be used only by physicians experienced in peripheral endovascular techniques and procedures.
• Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
• Do not use the device after the use by date.
• Prior to use, carefully examine the unit to verify that the sterile package or product has not been damaged during shipment.
• Take care not to damage or drop the product or accessories when removing them from the package.
• 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.
• Before removing the microcatheter from the carrier hoop, flush the hoop with a minimum 10 cc (mL) of heparinized saline or appropriate flush solution to aid in removal and activate the hydrophilic coating. Do not allow the microcatheter to dry once it has been hydrated.
• Flush the microcatheter lumen and guiding catheter prior to and during use. Do not allow the microcatheter lumen to dry once it has been hydrated.
• Avoid wiping the device with dry gauze as it may damage the hydrophilic coating.
• Do not use solvents to wipe the catheter as it may damage the hydrophilic coating.
• Avoid excessive wiping of the coated device.
• Inspect the microcatheter and guidewire prior to use for any surface irregularities, bends, kinks, or other damage. Also exercise care in handling them during the procedure to reduce the possibility of accidental damage. Do not use a microcatheter or guidewire that has been damaged.
• Do not attempt to straighten a guidewire that has been kinked or bent. Do not advance a kinked guidewire into a microcatheter, as this may increase the potential of guidewire damage.
• Before connecting to a power injector, flush the microcatheter using a syringe and check for any restriction in the lumen. Identify and resolve the cause of any restriction or replace the microcatheter with a new microcatheter before connecting to a power injector.
• Do not introduce the microcatheter without guidewire support as this may cause damage to the shaft of the catheter.
• When the microcatheter and/or guidewire are in the body, they should be manipulated only under fluoroscopy. Do not attempt to move the microcatheter and/or guidewire without observing the resultant tip response.
• To avoid guidewire damage and possible shearing of the polymer and/or coating, do not withdraw or manipulate the guidewire through a metal needle cannula. This may also damage the hydrophilic coating.
• 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.
• Do not power inject through the Rotating Hemostatic Valve (RHV) or Y-adapter.
• Excessive tightening of a hemostatic valve onto the microcatheter shaft or guidewire may result in damage to the microcatheter and/or abrasion of the coating of the wire.
• Excessive tightening of the torque device onto the guidewire may result in abrasion of the guidewire coating.
• If using a pre-loaded system, care should be taken when removing the preloaded system from the carrier tube as the pre-loaded guidewire extends beyond the distal tip of the microcatheter.
• It is recommended that a continuous heparanized saline or appropriate flush solution flush be maintained between the microcatheter and the guidewire during the procedure. Flushing prevents contrast crystal formation and/or clotting on the guidewire and in the microcatheter lumen.
• If other interventional devices are used with the microcatheter, then refer to that product labeling for intended use, contraindications and potential complications associated with the use of that interventional device.
• Always verify tip response of the microcatheter and/or guidewire under fluoroscopy and the position of the proximal portion of the microcatheter and/or guidewire, to avoid shaft coiling and/or damage.
• If resistance is felt during rotation or advancing of the microcatheter and there is no visible tip response, stop and rotate or move in the opposite direction to release tension.
• Do not use excessive force to manipulate or advance the microcatheter to avoid microcatheter kink or vessel damage.
• Should the nitinol shaft of the microcatheter fracture under too much tension, attempt to advance a guidewire through the fracture point and past the distal lumen, or retract the microcatheter into the guiding catheter. Then withdraw the system in a smooth motion, minimizing any rotation and torqueing.
• Check labeled diameter of the microcatheter and verify compatibility in table 1 with the guidewire outer diameter prior to use.
• The guidewire insertion tool, the microcatheter introducer (if applicable), the RHV or Y-adapter, the steam shaping mandrel (if applicable), and the torque device are not intended to enter the body.
• Abrasion of the hydrophilic coating may be caused by a tight microcatheter. Use of incompatible devices may result in damage to the guidewire or hydrophilic coating. If coating is damaged or any resistance is felt during introduction of the microcatheter, exchange the guidewire and the microcatheter.

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

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

• Do not use this product after the “Use By” date.
• Do not introduce the microcatheter without guidewire support as this may cause damage to the proximal shaft of the catheter.
• Always verify tip response of the microcatheter and/or guidewire under fluoroscopy and the position of the proximal portion of the microcatheter, to avoid shaft coiling and/or damage.