Guide Catheters

Prescriptive Information

Runway Guide Catheter Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

Indications

Boston Scientific Guide Catheters are intended for use in general intravascular, coronary and peripheral applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Contraindications

None known.

Warnings

Guide catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications and risks associated with angioplasty is necessary before performing this procedure. Due to the size and relative stiffness of guide catheters, extreme care must be taken to avoid damage to the vessel walls through which this catheter passes. This catheter may occlude smaller vessels. Care must be taken not to completely block blood flow. 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.

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Adverse Effects

Other potential adverse reactions which may result from the improper use of the device include arrhythmia, bleeding complications, death, embolism, hematoma at the puncture site, hemorrhage, infection, myocardial ischemia and/or infarction, neurological deficit including stroke, pseudoaneurysm, vascular thrombosis, vessel damage, vessel occlusion, vessel spasm, and vessel trauma, including dissection, perforation and/or rupture.

Cautions

• Manipulate the guide catheter only while under fluoroscopic observation.
• Care should be taken to control the position of the guide catheter tip during manipulation of the therapeutic device.
• Inspect the guide catheter prior to use to verify the size, shape and condition of the catheter as suitable for the specific procedure.
• Check the labeled diameter of both the therapeutic device and guide catheter prior to use to ensure compatibility. The large internal diameter of the catheter permits injection with little force being required on the syringe. Hand inject slowly whenever attempting to opacify the vessels via this catheter. Do not use opened or damaged packages. Store catheters in a dry, dark, cool place. Use prior to the "Use By" date. Rotate inventory to maintain fresh stock. To avoid damaging the tip of this catheter during removal from the package, grasp the hub and slowly withdraw the catheter. Rapid removal may result in damage to the catheter or tip.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Trademark

RunWay is a trademark of Boston Scientific Corporation or its affiliates.

Mach 1 and Wiseguide Guide Catheter Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

Indications

Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Contraindications

None known.

Warnings

Guide catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications, and risks associated with coronary angioplasty is necessary before performing this procedure.

Due to the size and relative stiffness of guide catheters, extreme care must be taken to avoid damage to the vessel walls through which this catheter passes. This catheter may occlude smaller vessels. Care must be taken not to completely block blood flow. The guide catheter is designed and intended for one procedure only. Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused. Reuse can compromise the guide catheter’s performance characteristics and can cause infection, even if resterilized. Accordingly, Boston Scientific will not be responsible for any direct or consequential damages or expenses resulting from reuse of the catheter.

Potential Adverse Effects

Other potential adverse reactions which may result from the improper use of this device include blood loss, infection, hematoma at the puncture site, and embolism.

Cautions

• Manipulate the guide catheter only while under fluoroscopic observation.
• Inspect the guide catheter prior to use to verify the size, shape, and condition of the catheter as suitable for the specific procedure.
• Check the labeled diameter of both the therapeutic device and guide catheter prior to use to ensure compatibility.
• Use of a power injector is not recommended. The large internal diameter of the catheter permits rapid injection with little force being required on the syringe. Hand inject slowly whenever attempting to opacify the vessels via this catheter. The maximum recommended injection pressure is 500 psi/ 34 atm/bar.
• Store catheters in a dry, dark, cool place.
• Do not expose catheters to strong solvents.
• Rotate inventory to maintain fresh stock.
• To avoid damaging the tip of this catheter during removal from the package, open as follows: Grasp the hub and slowly withdraw the catheter. Rapid removal may result in damage to the catheter or tip.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Trademark

Mach 1, Wiseguide and CLS are trademarks of Boston Scientific Corporation or its affiliates.