Contraindications:
The device is contraindicated for use in carotid arteries.
Warnings and Precautions:
1) The CROSSER® Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA).
2) Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product from a damaged package.
3) DO NOT activate the CROSSER® Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. Always use REFRIGERATED SALINE.
4) The CROSSER® Recanalization System should be used in conjunction with proper anticoagulation agents.
5) When exposed to the vascular system, never advance or withdraw the CROSSER® Catheter without proper fluoroscopic guidance.
6) It is not recommended to use the CROSSER® Catheter over wires which have polymer-jacketed distal ends.
7) Do not exceed 5 minutes of activation time as CROSSER® Catheter malfunction may occur. If 5 minutes of activation time is achieved exchange for a second CROSSER® Catheter before resetting the CROSSER® Generator.
8) When using the CROSSER® Catheter 14S with the SIDEKICK® or MICROSHEATH® XL Support Catheter Tapered, the CROSSER® Catheter can be advanced approximately 15 cm from the tip of the support catheter before resistance is encountered due to the taper on the CROSSER® Catheter aligning with the taper on the support catheter. A taper lock-up marker (single black marker on the CROSSER® Catheter shaft) is located 127 cm from the distal tip for the 146 cm CROSSER® Catheter and 87 cm from the distal tip for the 106 cm CROSSER® Catheter. The taper lock-up marker can be used as an indicator that the tapers on the catheters are nearing alignment; advance the CROSSER® Catheter slowly. Do not continue to advance the CROSSER® Catheter if resistance is encountered.
9) When manipulating the CROSSER® Catheter, the Catheter shaft may become warm to the touch. A warm feeling is normal, however, if the Catheter shaft becomes hot discontinue use immediately and withdraw from patient. Once removed from the patient confirm that irrigation is flowing.
10) When using the CROSSER® Catheter in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the CROSSER® Catheter tip. Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.
11) Position Foot Switch and cable to minimize potential tripping hazard.
12) Ensure CROSSER® Generator is securely mounted to IV pole to reduce risk of falling.
13) Should high frequency vibration fail to stop when foot switch is released, power off CROSSER® Generator or unplug from power receptacle.
14) Never activate the CROSSER® Generator without a CROSSER® Catheter attached to the Transducer.
15) Store in a cool, dry, dark place. Rotate inventory so that the catheters and other dated products are used prior to the “Use By” date.
16) This device has been designed for single use only. Reusing this medical device bears with it the risk of crosspatient contamination as medical devices - particularly those with long and small lumina, joints, and/or crevices between components - are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for and indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or mircroorganisms which may lead to infectious complications.
17) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/ or mechanical changes.
18) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.
19) GeoAlign® Marking System is designed to be used as an additional reference tool to accompany the interventionalist standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter of the target lesion and prior to device activation.
