GUIDING CATHETER
INSTRUCTIONS FOR USE
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
© 2020 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic
company.
Explanation of symbols on package labeling
Guiding catheter
Contents: one device
Contents
Length
Inner diameter
Outer diameter
Sterilized using ethylene oxide
Date of manufacture
Consult instructions for use at this website
Manufactured in
Manufacturer
Keep away from sunlight
For US audiences only
Do not reuse
Use-by date
Lot number
Catalog number
ENGLISH
Read instructions before use
Refer to the symbols section of this document for symbol denitions.
Indications
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Contraindications
None known.
Warnings
• For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or create a risk of contamination
of the device which could result in patient injury, illness or death. Cleaning, disinfection and resterilization may compromise the essential material and design characteristics of the device leading to device failure.
• Do not use if package is opened or damaged.
• Due to the size and relative stiffness of the guiding catheters, extreme care must be taken to avoid damage to the wall of the vessels through which this catheter passes.
• Due to the size of the non-tapered tip, this catheter may occlude smaller vessels. Care must be taken not to completely block ow.
• When there is limited clearance between devices and the guide catheter lumen, devices must be advanced and withdrawn slowly with the valve open to reduce the risk of embolism.
• Use catheters prior to the expiration date specied on the package.
Precautions
• The large internal diameter of the catheter permits injection with little force being required on the syringe. Inject slowly whenever attempting to opacify the vessels via this catheter.
• Guiding 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.
• This device has been delivered STERILE. Careful inspection prior to use should verify the size, shape, and condition of the catheter as suitable for the specic procedure.
• Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• If resistance is encountered at any time during the insertion of the interventional device through the lumen of the guiding catheter, do not force passage. Determine the cause of resistance before proceeding. If
the cause of resistance cannot be determined, remove the entire dilatation system.
• If the guide catheter is torqued when kinked it may cause damage that could result in separation along the catheter shaft. In the event the catheter shaft becomes kinked, withdraw the guide catheter, guide wire,
and catheter sheath introducer.
• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
Adverse effects
Use of guiding catheters may give rise to the following complications:
• Hemorrhage or hematoma
• Allergic reaction to contrast medium
• Infection
• Embolism
• Vessel or heart dissection or perforation
• Vessel spasm
• Thrombosis
• Myocardial infarction
• Stroke
• Death
• Vascular occlusion
Instructions for use
Verify that the catheter has not been damaged in shipment. If contamination or damage is suspected for any reason, do not use the catheter. Contact your local Medtronic representative.
1. Catheter preparation
a. Using sterile technique, carefully remove the catheter from its package by withdrawing the die-cut card with the mounted catheter from the pouch. Carefully separate the catheter from the card to avoid
damage to the product.
b. Flush catheter with sterile saline solution using a 10cc syringe.
2. Insertion technique
a. Prepare the patient for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.
b. The Medtronic Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.
c. Introduce the guiding catheter over a previously placed standard angiographic wire. Aspirate and ush the guiding catheter after the removal of the angiographic wire following established angiographic
techniques.
d. The catheter should be manipulated only while under uoroscopic observation.
e. The guiding catheter should address the selected vascular site.
3. Removing the catheter
a. At the completion of the angioplasty procedure, aspiration during withdrawal of the catheter is recommended.
Disclaimer of warranty
The warnings contained in the product labeling provide more detailed information and are considered an integral part of this disclaimer of warranty. Although the product has been manufactured under carefully
controlled conditions, Medtronic has no control over the conditions under which this product is used. Medtronic, therefore, disclaims all warranties, both express and implied, with respect to the product, including,
but not limited to, any implied warranty of merchantability or tness for a particular purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct, incidental, or consequential
damages caused by any use, defect, failure, or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No person has any authority to bind Medtronic to
any representation or warranty with respect to the product.
The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held to
be illegal, unenforceable, or in conict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this disclaimer of warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term held to be invalid.
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