Indications, safety, and warnings for TruSelect 2.6™ Microcatheter

The TruSelect 2.6 Microcatheter is intended to provide a conduit for the selective infusion of diagnostic, embolic, or therapeutic agents to target vessels within the peripheral vasculature during endovascular procedures. The microcatheter is coaxially tracked over a steerable guidewire to access the distal peripheral vasculature. Diagnostic, embolic, or therapeutic agents should 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. 

• Failure to abide by the warnings in this labeling might result in damage to the device, which may necessitate intervention or result in serious adverse events. 

• Contents supplied STERILE using ethylene oxide (EO) sterilization process. Do not use if sterile barrier is damaged or if device sterility has been compromised. If damage is found, call your Boston Scientific representative. 

• Do not advance or withdraw an endovascular device against resistance until the cause is identified. Movement of a microcatheter or guidewire against resistance may cause device damage, separation and/or vessel damage or perforation.  

• The infusion pressure with this microcatheter should not exceed 900 psi (6205 kPa). Infusion pressure in excess of this maximum or if the microcatheter is blocked 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. Identify and resolve the cause of the blockage or replace the microcatheter with a new microcatheter before resuming infusion. 

• The use of embolic agents may result in occlusion of the microcatheter and require the exchange of the microcatheter. 

• TruSelect 2.6 Microcatheter is not intended for use in the coronary vasculature or neurovasculature. 

• The safety and effectiveness of the device has not been established or is unknown in vascular regions other than the peripheral vasculature during endovascular procedures.  

• In the event of any malfunction, do not use the device and immediately call your Boston Scientific representative. 

• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

• This device should be used only by physicians experienced in percutaneous, peripheral endovascular, diagnostic 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.  

• Avoid damaging or dropping the product or accessories when removing them from the package. Verify the product integrity and function before use. Do not use if damaged. 

• If resistance is felt during microcatheter removal from the hoop, it is recommended to flush the hoop with a minimum 10 cc (mL) of appropriate flush solution using the Y-Connector on the Hoop 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. 

• If reactivation of hydrophilic coating is required use wet gauze. Avoid excessive wiping of the coated device. 

• Inspect the microcatheter and guidewire prior to use for any surface irregularities, bends, kinks, or other damages. Also exercise care in handling the microcatheter and guidewire during the procedure to reduce the possibility of accidental damage. 

• Flush the microcatheter with a syringe and check for lumen resistance before connecting to a power injector; resolve any resistance or replace the microcatheter to avoid device damage, or patient injury. Do not exceed the microcatheter pressure rating (900 psi [6205 kPa]).  

• Do not advance the microcatheter without guidewire support as this may cause damage to the proximal shaft of the catheter. 

• Manipulate the microcatheter and/or guidewire only under fluoroscopy, ensuring continuous visualization of both tip response and proximal shaft position to prevent unintended movement, coiling, or device damage. 

• Advancing the microcatheter into narrow sub-selective vasculature may interfere with the microcatheter removal. 

• Do not power inject through the Y-Adapter.  

• Excessive tightening of the Y-Adapter onto the microcatheter shaft or guidewire may result in damage to the microcatheter and/or abrasion of guidewire coating. 

• It is recommended that a continuous appropriate flush solution 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. 

• If resistance is felt while rotating or advancing the microcatheter and there is no visible tip response, this may indicate tension build-up. Do not continue manipulating the device, as doing so could lead to device damage or patient injury.  

• Do not use excessive force to manipulate or advance the microcatheter to avoid microcatheter kink or vessel damage. 

• Kinking or stretching of the microcatheter shaft under tension may affect device performance and can pose risks during device withdrawal, including patient injury.

Potential Adverse Events which may be associated with the use of a microcatheter or the 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.)