The RAILWAY™ Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.
Avoid the use of the RAILWAY™ Sheathless Access System in vasculature with extreme tortuosity, calcified plaque or thrombus.
Radial access is contraindicated in patients with:
- Inadequate circulation to the extremity as evidenced by signs of artery occlusion or absence of radial pulse.
- Hemodialysis shunt, graft or arterio-venous fistula involving the upper extremity vasculature.
- Prior to radial access procedures, it is recommended to verify adequate collateral flow through the ulnar artery, such as with an Allen test. If collateral blood supply to the hand is considered inadequate, an alternate access site should be considered.
- Do not use Ethiodol® or Lipiodol® contrast media, or other such contrast media which incorporates components of these agents, as solvents used in these media may have a deleterious effect on the device
- For the Introcan SafetyR IV Catheter* needle, do not reinsert the needle into the IV catheter at any time. The needle could damage the IV catheter, resulting in an IV catheter embolus.
- If using a hydrophilic wire, do not use with a bare needle or metal torque device, as this may damage the integrity of the coating.
- Use of alcohol, antiseptic solutions, or other solvents should be avoided, as they may adversely affect the device.
- Manipulate the mini-guidewire slowly and carefully to avoid damage to the vessel wall, while monitoring tip position and movement under fluoroscopy.
- Failure to follow the procedural steps when exchanging a guiding catheter may result in loss of vessel access.
- Do not manually re-shape the distal tip of the dilator or the mini-guidewire by applying external force intended to bend or affect the shape of the dilator or mini-guidewire.
- The dilator must only be advanced while over a guidewire. Advancing the dilator without a wire in place may cause vascular complications.
- Persons with allergic reactions to nickel may suffer an allergic response to components of this device.
- This product is intended for use by professionals who have been trained to perform coronary diagnostic and interventional procedures.
- This product is intended to be used under fluoroscopic guidance.
- Use the product immediately after opening the package.
- Store in a cool, dark, dry place.
- Prior to use, confirm that the vessel dilator size is appropriate for the access vessel, guiding catheter and with any other accessories to be used.
- The entire procedure, from skin stick to product removal, must be performed aseptically.
- Do not use if package is open or damaged.
- Do not alter this product.
- Use prior to “Use By” date.
- This product is intended for radial arterial access and tracking up to, but not beyond, the subclavian artery only. No data has been collected to demonstrate the safety and effectiveness of
this product for use as a diagnostic or interventional device.
- If the device becomes kinked or increased resistance is felt upon insertion or advancement of the vessel dilator, investigate the cause before continuing. If the cause of the resistance cannot
be determined and corrected, discontinue the procedure and withdraw the vessel dilator.
- If increased resistance is felt upon withdrawal of the vessel dilator, investigate the cause before continuing, as excessive force during vessel dilator withdrawal can cause product damage or vascular complications.
During the procedure, provide a proper anticoagulant or antiplatelet therapy to the patient.
Please refer to the Instructions For Use for complete information, including indications, precautions, warnings, and potential adverse events.