Inno-Pathwire Guidewire
Read all instructions prior to use, including all warnings and precautions throughout these instructions. Failure to do so may result in complications.
 
CAUTIONS
• This Inno-Pathwire should be used only by physicians trained in angiography and Percutaneous Transluminal Coronary Angioplasty (PTCA), and/or Percutaneous Transluminal Angioplasty (PTA).
• Refer to the instructions supplied with the interventional devices to be used with the Inno-Pathwire for their intended uses, contraindications, and potential complications.
• Do not use if the package is open or damaged.
• Do not use if it is expired.
 
CONTENTS
One (1) Guidewire
 
DEVICE DESCRIPTION
The Inno-Pathwire is a steerable guidewire available in a diameter of 0.014" (0.36 mm) and an effective length of 190 cm. The distal tip is shapeable. Before use, the tip can be shaped per standard technique. The distal tip is visible under X-ray to assist the physician with the position and movement of the guidewire. The distal segment of the guidewire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guidewire movement within the catheter and arteries. The proximal end of the guidewire is coated with PTFE which reduces friction of the wire.
 
Device Specification
The Inno-Pathwire guidewires has three models. Refer to the product label for product specifications (e.g., wire length, diameter, length of tip radiopacity, and shaft stiffness).
 
 
 


Note: STS and MDS are more appropriate for use in more distal and tortuous vasculatures. Conversely, EXS is more appropriate for the less distal and less tortuous vasculatures.
 
HOW SUPPLIED
The Inno-Pathwire guidewires are sterile, non-pyrogenic and intended for single use only. The Inno-Pathwire is sterilized with Ethylene Oxide gas. The Inno-Pathwire is a single use device and cannot be re-sterilized or reused in other patients. Re-sterilization may compromise the integrity of the guidewire leading to contamination and diminished safety and/or performance of the device.
 
STORAGE
Store in normal temperatures, in a clean, well ventilated environment. Avoid direct sunlight and storing in abnormal temperatures or a humid environment.
 
EXPIRATION
The Inno-Pathwire shall be valid for two years under the proper storage conditions. Please refer to the product label for the manufacturing date and expiration date.
 
Intended use
The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
 
CONTRAINDICATIONS
The Inno-Pathwire is not intended for use in:
• The cerebral vasculature.
• Patients considered not acceptable for percutaneous intervention.
• Patients who are allergic to the guidewire materials, PTFE, 304 stainless steel, nickel-titanium alloy, and/or platinum tungsten alloy.
 
Warnings
• This device is designed and intended for "Single Use Only". Do not re-sterilize and/or reuse.
• Carefully observe the instructions for use. Failure to do so may result in vessel trauma, guidewire damage, guidewire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.
• Do Not:
o Push, withdraw, auger or torque a guidewire that meets resistance.
o Torque a guidewire if the tip becomes entrapped within the vasculature.
o Allow the guidewire tip to remain in a prolapsed condition
• Do:
o Advance or withdraw the guidewire slowly.
o Use the radiopaque marker of the interventional device to confirm position.
o Examine the tip movement under fluoroscopy before manipulating, moving or torqueing the guidewire.
o Observe the wire under fluoroscope for tip buckling, which is a sign of resistance.
o Maintain continuous flush while removing and reinserting the guidewire to prevent air entry and/or trauma. Exchange the guidewire slowly to prevent air entry/or hematoma.
o When reintroducing the guidewire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel with the vessel wall.
 
PRECAUTIONS
• Confirm the compatibility of the guidewire diameter with the interventional device before actual use.
• Use the Inno-Pathwire immediately after the package is opened.
• Handle with care. Prior to use and when possible during the procedure, inspect the guidewire carefully for bends, kinks, or other damage. Do not use damage guidewires. Using a damaged guidewire could result in vessel damage and/or inaccurate torque response. Free movement of the guidewire within the interventional device is an important feature of a steerable guidewire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with the adjustable valve if it is found to inhibit guidewire movement.
• Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the Inno-Pathwire in a metal cannula or sharp-edged object.
• If the guidewire requires re-insertion into the same patient during the same interventional operation, it should first be rinsed in a container filled with Heparinized solution. The blood residue on the guidewire should be wiped clean with a saline-soaked gauze. Do not use alcohol, an anti-corrosion solution or other solvents to wipe the guidewire; these solutions could have an adverse effect on the surface of the guidewire.
 
PREPARATION FOR USE
Prior to the procedure, carefully examine the equipment and the interventional devices to be used for defects. Do not use any defective equipment or products.
1. Prepare the interventional device according to the manufacturer's instructions. Be sure to flush the guidewire lumen prior to introducing the guidewire.
2. Before removing the guidewire from the wire dispenser, inject normal saline into the hub end of the dispenser to thoroughly wet the complete surface of the guidewire.
3. Carefully remove the guidewire from the dispenser by pushing the exposed section of the guidewire into the dispenser until the guidewire tip and a portion of the core exit the end of the hoop. Then grasp the core of the wire to remove it totally from the dispenser. Avoid damaging the fragile guidewire tip. Do not grasp and pull the tip of the wire while removing the guidewire from the dispenser. If the guidewire cannot be easily removed from the dispenser, inject more saline and attempt to remove the guidewire again.
4. Do not reinsert the guidewire into the dispenser once it has been removed.
5. If the surface of the hydrophilic-coated wire becomes dry, wetting the surface with normal saline to renew the hydrophilic effect. Be sure to thoroughly wet the guidewire before reintroduction into an interventional device.
6. After the guidewire is withdrawn from the body, it should be wiped clean with saline-soaked gauze and kept wet.
7. If indicated, the guidewire tip may be carefully shaped using standard practices. Do not use a shaping instrument with a sharp edge as damage can occur to the tip.
 
DIRECTIONS FOR USE
1. Carefully insert the guidewire through the guidewire lumen hub of the interventional device.
2. Advance the guidewire until its tip is just proximal to the interventional device tip.
3. If using a guiding catheter, engage the guiding catheter and insert the interventional device/ guidewire assembly through the hemostatic valve. Advance the system through the guiding catheter until it is just proximal to the tip of the guiding catheter.
4. Tighten the hemostatic valve to create a seal around the interventional device. Ensure intentional guidewire movement is still permitted.
5. Attach the torque device to the guidewire, if desired.
6. Under fluoroscopy, advance the guidewire out of the interventional device while securing the interventional device in place. Use the torque device to steer the guidewire across the lesion.
7. Secure the guidewire in place while tracking the interventional device over it and to the target lesion.
8. If a different tip configuration or guidewire is indicated, carefully remove the guidewire while observing guidewire movement under fluoroscopy.
9. Reshape the guidewire tip according to standard practice or prepare another guidewire to be used.
10. Reinsert the guidewire following Steps 1 through 7 of this section.

product performance
The guide wire has a 1:1 torqueability
The tip of the guidewire is clearly visible under X-ray
The tip of the guidewire can be shaped repeatedly accordin to the doctor's needs
Stable and superior hydrophilic coating allows products to move freely in blood vessels