CONVEY™ Guiding Catheter
Indications, Safety, and Warnings
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey guiding catheter is intended to be used in the coronary or peripheral vascular system.
Inspect the catheter before use to verify that labeled dimensions, shape and condition are suitable for the specific procedure, and to ensure compatibility with other devices.
Do not expose to organic solvents.
When there is limited clearance between devices and the guide catheter lumen, devices must be advanced and withdrawn slowly with the valve open to reduce the risk of embolism.
An appropriate anticoagulation therapy should be applied.
In order to avoid catheter and blood vessel damage, insert the catheter through an introducer and carefully advance, manipulate and withdraw the catheter over a pre-positioned guidewire.
In case of catheter kink, withdraw the entire system. Torque of a kinked catheter can result in vessel damage and catheter separation.
Use slow hand injection of contrast agent whenever attempting to opacify the vessels using this catheter.
While manipulating a therapeutic/diagnostic device, always control the position of the guiding catheter tip.
If strong resistance is encountered during manipulation of the guiding or the therapeutic/diagnostic catheter, do not force passage. Determine the cause of the resistance before proceeding. If the cause cannot be removed, withdraw all devices simultaneously.
The guiding catheter may occlude small target vessels. Avoid obstruction of the blood flow. Consider using a guiding catheter featuring side holes.
Use of this product in clinical procedures should be restricted to those physicians who have had relevant and adequate training and are familiar with the conceivable complications that may occur at any time during or after the procedure.
Possible complications include, but are not limited to the following:
- Bleeding complications
- (Air) Embolism
- Haematoma at the puncture site
- Myocardial ischemia and/or infarction
- Neurological Deficit including Transient Ischemic Attack / Stroke
- Plaque migration
- Thrombus formation
- Vessel trauma including dissection, perforation and / or rupture
- Vessel occlusion
- Vessel spasm