Instructions for Use - ASAHI Tornus Specialty Catheter (U.S.)

Rx ONLY

Indications for Use:
This product is intended to be used in conjunction with a steerable guidewire to access discreet region of the vasculature, and for guidewire exchange.

Single Use Only

Contraindications:
LIFE-THREATENING ADVERSE EVENTS MAY ENSUE.

• This product is intended for single use only. Do not resterilize and/or reuse.
• This product should not be used if the package is damaged or open.
• This product must be used exclusively for coronary or peripheral arteries. Never use it for other kinds of blood vessels.
• Do not perform procedures using the catheter on patients who are or could be pregnant. (The fetus is affected by X-rays under fluoroscopy.)
• Do not apply this product to patients who are not eligible for coronary bypass operation, or have exhibited a severe allergic reaction to operation-related drugs, such as contrast media.
• Do not apply this product to patients who are considered by the physician in attendance to be ineligible.
• Do not apply this product to lesions on the left coronary artery main trunk, which is not protected by a bypass or collateral circulation.
• Do not apply this product to patients with anamnesis of coronary spasm.
• Do not apply this product to lesions where this catheter needs to pass through stent strands.

Warnings
Carefully read and observe all Warnings. Failure to do so may result in life-threatening adverse events in the worst case.

• If any resistance or something abnormal is felt when operating this product, do not continue the operation while the causes are unclear. If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications. If there are complications as a result of the removal of the entire system, stop immediately the percutaneous transluminal coronary angioplasty (PTCA), and perform appropriate treatment at the discretion of the physician. (Continuing the operation while the cause of the problem is not identified may cause damage to or rupture of the catheter, and damage the blood vessel.)
• When torquing this catheter inside the blood vessel, never use both hands on the catheter connector, or other means of applying force to turn the catheter. Always use one hand on the catheter connector to turn the catheter, relieving the torsion of the catheter appropriately when it is accumulated. Do not exceed 20 rotations in the same direction when the catheter tip is trapped by the lesion. While rotating the catheter, carefully observe the proximal end of the cover tube (the section of 5cm length from the strain relief). If any breakage is recognized in this section during rotation, stop the rotation and remove and exchange the catheter while paying full attention.
• Closely observe to ensure that the guidewire is tightly secured and not following the catheter movement during catheter operation. If the guidewire follows and moves in concert with the push, pull, or rotation of the catheter, stop the operation immediately and avoid further operation while the causes are unclear. In such a situation, avoid excessive manipulations, and carefully remove the catheter together with the guidewire while paying full attention to avoid complications. If the removal of the catheter together with the guidewire is impractical, stop immediately the procedure, and perform appropriate treatment at the discretion of the physician. (Continuing the operation may cause the guidewire to break or become damaged, which may injure the blood vessel.)
• Never use guidewires larger than the recommended size. (Resistance may be felt while advancing or withdrawing a guidewire larger than the recommended size, which may cause the catheter to become damaged or break, or the blood vessel to become damaged.)
• This catheter must be used under fluoroscopy only by a physician who is fully trained in PTCA. (Unskillful procedure may cause an error in operation or misjudgment, leading to damage to the blood vessel.)
• It is recommended that this catheter only be used at a medical institution capable of promptly performing an emergency coronary bypass operation. If the emergency operation is not performed promptly when needed, for example, in the case of an accidental patient injury during a procedure using TORNUS, life-threatening adverse events may ensue in the worst case.
• Always advance the guidewire ahead of the catheter before attempting any manipulation of the catheter, such as advancement, withdrawal, or rotation. (If the guidewire is not advanced ahead of the catheter, the blood vessel may be damaged.)
• During the procedure, the patient needs an appropriate anticoagulant or antiplatelet treatment depending on the patient's clinical conditions. (In the absence of an appropriate treatment, thrombi may form, leading to complications.)

Precautions

• Warning
  This product is intended for single use only. Do not resterilize and/or reuse. Do not use if the package is opened or damaged. Always open the package just prior to use.
• Important precautions

1. Prior to use, always confirm that the product is compatible with peripheral equipment pertinent to PTCA.
2. Do not modify the product for whatever purpose.
3. Prior to use, flush the inside of the holder and of the catheter with heparinized and sterilized saline, and confirm that all the surfaces are wet before taking out the product for the insertion procedure.
4. If the product is distorted, for example, bent or broken, due to accidental damage during operation, discontinue the use of the catheter.
5. Be sure to use the product before the expiration date indicated on the label.
6. When using hydrophilic-coated guidewires, carefully manipulate the guidewire and the catheter to avoid abrasion of the hydrophilic coating on the guidewire.
7. Do not wet the surface of the product with alcohols, gluconic acid chlorhexidine aqueous solution, or the like, nor wipe the surface with gauze or absorbent cotton soaked with such solvents.
8. Do not use the product for drug solution injections because the product shaft is not tight enough to seal liquid; and the product connector is made of polycarbonate, which may come in contact with and eroded by some kind of drug solution.
9. If any crack is detected on the connector, immediately replace the catheter with a new one.
10. Either attach an extension wire to the guidewire or use a longer guidewire before inserting or removing the product. Do not adopt the catheter removal method (commonly known as Nanto method) in which the catheter is removed by making use of the injection pressure of heparinized and sterilized saline.
11. When the catheter is reinserted into the body, be sure to flush the catheter again to remove thrombosis on the surface.
12. Use an inserter to insert a guidewire through the connector of the product.
13. It may happen that the catheter advances too far toward periphery over the target area of the operator's aim. The manipulation of the product demands careful attention to the position and movement of the catheter tip under fluoroscopy.
14. Gently wipe blood or contrast medium particles adhering to the surface of the product with gauze or absorbent cotton soaked with heparinized and sterilized saline. However, never use gauze or absorbent cotton wetted with drugs or other kinds of solvents.

ADVERSE EVENT INFORMATION

Defects and adverse events may ensue from the improper use of the product. A serious adverse event may lead to a severe complication or death. Prevent such defects and adverse events from occurring by carefully reading this document and complying with the directions contained in it.

1) Defects

• Twist and sharp bend
• Damage
• Rupture
• Removal difficulty, etc

If these defects arise, avoid excessive manipulation, and carefully remove the entire catheter system while paying full attention to avoid complications.

Note: If the catheter is damaged, this product may cut into a blood vessel wall. Extreme caution needs to be taken when removing a damaged device. In the case of complications resulting from the removal of the entire system, stop immediately the procedure, and perform appropriate treatment at the discretion of the physician.

2) Adverse events

• Acute myocardial infarction
• Unstable angina
• Arrhythmia including ventricular fibrillation
• Blood vessel damage, etc

AMK-D879 050803

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