Indications for Use:

The BD Recanalization System (Console and Footswitch) and the Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.

Crosser iQ™ Ultrasonic CTO Device:

The Crosser iQ™ Ultrasonic CTO Device is intended for use only with the BD Recanalization System (Console and Footswitch).

BD Recanalization System:

The BD Recanalization System (Console and Footswitch) is intended for use only with the Crosser iQ™ Ultrasonic CTO Crossing Device.

Following is a list of Contraindications, Warnings and Precautions. Failure to observe any of the noted contraindications, warnings and precautions may result in complications that may lead to adverse effects and/or serious patient injury up to and including patient death.

Contraindications:

The Crosser iQ™ Ultrasonic CTO Device is contraindicated for use in carotid arteries.

Warnings:

• Contents are supplied sterile. DO NOT use if sterile barrier is opened, damaged or contamination is evident.
• DO NOT use after expiration date.
• Visually inspect the packaging to verify that the sterile barrier is intact. DO NOT use if the sterile barrier is opened, damaged or contamination is evident.
• The Crosser iQ™ Ultrasonic CTO Catheter has been designed for single patient use. Reusing this medical device bears the risk of cross-patient 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 an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. Additionally, re-use and/or repackaging may compromise the structural integrity and/or material and design characteristics of the device, which may lead to device failure, and/or lead to patient injury.
• Flush Crosser iQ™ Ultrasonic CTO Catheter prior to insertion and reinsertion of device.
• 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 Crosser iQ™ Ultrasonic CTO 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.
• DO NOT immerse the handle of the Crosser iQ™ Ultrasonic CTO Device in fluids. When preparing the catheter shaft working length, ensure that minimal fluids come into contact with device handle. Damage to the Crosser iQ™ Ultrasonic CTO Device and electrical shock could occur. The Crosser iQ™ Ultrasonic CTO Device is not protected against the ingress of fluids (IPX0).
• DO NOT activate the Crosser iQ™ Ultrasonic CTO Device without proper irrigation; risk of injury to operator or patient or damage to the Crosser iQ™ Ultrasonic CTO Device may occur. Establish proper irrigation (confirm continuous flow of saline from the tip of the crossing catheter) prior to introduction into the patient.
• When exposed to the vascular system, the Crosser iQ™ Ultrasonic CTO Device should be manipulated while under high-quality fluoroscopic observation. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Excessive force may result in damage to the Crosser iQ™ Ultrasonic CTO Device or vasculature.
• When manipulating the Crosser iQ™ Ultrasonic CTO Device, 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 the patient. Once removed from the patient, confirm that irrigation is properly flowing by observing the tip of the Crosser iQ™ Ultrasonic CTO Device during system test.
• It is NOT recommended to use the Crosser iQ™ Ultrasonic CTO Device over guidewires which have polymer-jacketed distal ends.
• When using the Crosser iQ™ Ultrasonic CTO Device in tortuous anatomy, the use of a Support Catheter is recommended to prevent kinking or prolapsing of the Crosser iQ™ Ultrasonic CTO Device tip. Kinking or prolapsing of the tip could cause catheter breakage and/or malfunction.
• DO NOT exceed 5 minutes of activation time. If 5 minutes of activation time is achieved, exchange for a new Crosser iQ™ Ultrasonic CTO Device before restarting the BD Recanalization System (Console and Footswitch). Using a Crosser iQ™ Ultrasonic CTO Device for more than 5 minutes of activation time may cause Crosser iQ™ Ultrasonic CTO Device malfunction and is NOT recommended.
• Unplug the BD Recanalization System (Console and Footswitch) from power receptacle and/or switch power to ‘OFF’, and/or disconnect the Crosser iQ™ Ultrasonic CTO Device if high frequency vibration fails to stop when the Handle Activation Button is pushed off or Footswitch is released; risk of patient injury could occur.
• After contact with blood or use, the Crosser iQ™ Ultrasonic CTO Device is a biohazard. Handle and dispose as a biohazard in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.
• The safety and effectiveness of this device has not been evaluated in children or pregnant women.
• The safety and effectiveness of the device has not been established, or is unknown, in vascular regions other than those specifically indicated.
• A second double black exit marker on the Crosser iQ™ Ultrasonic CTO Device shaft denotes where the crossing device will “lock up” with the tapered Recon™ Support Catheter. If this occurs, advance the Crosser iQ™ Ultrasonic CTO Device with the Recon™ Support Catheter as one cohesive unit. DO NOT push the Crosser iQ™ Ultrasonic CTO Device further into or through the Recon™ Support Catheter as the devices could get stuck together and difficulty in removal and/or withdrawal of the device(s) may occur.
• The safety and effectiveness of using this device in stents or bypass grafts is unknown.
• Use appropriate anticoagulation to prevent or reduce device thrombosis, as this device has not been tested in the absence of anticoagulation.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• No modification to this equipment is allowed.
• Risk of injury or death to operator or patient can result from unauthorized modification to the BD Recanalization System (Console and Footswitch).
• DO NOT use in the presence of flammable anesthetics.
• DO NOT attempt to service the BD Recanalization System (Console and Footswitch).
• Switch power to ‘OFF’, unplug the BD Recanalization System from power outlet or disconnect the Crosser iQ™ Ultrasonic CTO Device if high frequency vibration fails to stop when the Handle Activation Button is pushed off or Footswitch is released; risk of patient injury could occur.
• Keep out of reach of patients. The BD Recanalization System (Console and Footswitch) must be at least 1.5 meters away from patient’s reach.
• The BD Recanalization System (Console) is equipped with an exhaust vent. DO NOT block the openings or internal heat buildup may occur, causing damage to the equipment.

Precautions

• Check that the Crosser iQ™ Ultrasonic CTO Device has not been damaged prior to use. DO NOT use if any product damage is visible.
• Exercise care in handling the Crosser iQ™ Ultrasonic CTO Device to reduce the potential of accidental damage.
• Exercise care in handling of guidewire to reduce the potential of accidental damage as kinks or bends can cause damage or malfunction with use of Crosser iQ™ Ultrasonic CTO Device.
• The BD Recanalization System (Console and Footswitch) and the Crosser iQ™ Ultrasonic CTO Device should only be used by individuals trained in percutaneous intravascular techniques and procedures.
• The BD Recanalization System (Console and Footswitch) and the Crosser iQ™ Ultrasonic CTO Device should be used in conjunction with proper anticoagulation agents.
• Ensure the BD Recanalization System (Console and Footswitch) is securely mounted to 5-caster IV pole to reduce risk of falling.
• If using the Footswitch for activation, position the Footswitch and corresponding Footswitch cord to minimize potential tripping hazard.
• Only use heparinized saline to flush the Crosser iQ™ Ultrasonic CTO Device.
• In the event of a power outage, power interruption, or system reset, replace the Crosser iQ™ Ultrasonic CTO Device before restarting the procedure.
• The 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 Crosser iQ™ Ultrasonic CTO Device to the target lesion and prior to device activation.
• This device is coated with a hydrophilic coating at the distal segment of the shaft. Please refer to the Directions for Use section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
• In order to activate the hydrophilic coating, it is recommended to wet the Crosser iQ™ Ultrasonic CTO Device with sterile saline solution immediately prior to its insertion in the body. Using different media other than the recommended solution could affect the hydrophilic coating and its performance.
• Avoid excessively wiping the coated portions of the device, or wiping with dry gauze, as this may damage the hydrophilic coating.
• DO NOT excessively bend, twist, or alter the shape of the device as it may compromise the integrity of the hydrophilic coating or result in device damage.
• Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.
• Avoid pre-soaking devices for extended periods, as this may impact the coating performance.
• In the instance of a cardiac event, disconnect the Crosser iQ™ Ultrasonic CTO Device from the BD Recanalization System and ensure that none of the components of the device are in contact with the patient or user prior to defibrillation.
• Check that the BD Recanalization System (Console and Footswitch) has not been damaged prior to use. DO NOT use if any product damage is visible.
• Exercise care in handling the BD Recanalization System (Console and Footswitch) to reduce the potential of accidental damage.
• The BD Recanalization System (Console and Footswitch) and the Crosser iQ™ Ultrasonic CTO Device should only be used by individuals trained in percutaneous intravascular techniques and procedures.
• Position the BD Recanalization System to allow easy access to separable power cord during use.
• DO NOT immerse the BD Recanalization System (Console) in fluids. The BD Recanalization System is NOT sealed against the ingress of fluids (IPX1). Damage to the BD Recanalization System and electrical shock may occur.
• In the event of a power outage, power interruption, or system reset, replace the Crosser iQ™ Ultrasonic CTO Device before restarting the procedure.
• Ensure the BD Recanalization System (Console) is securely mounted to 5-caster IV pole, with display oriented in the upper left corner, and no more than 48 inches (122 cm) above the ground to reduce the risk of falling.
• If using the Footswitch for activation, position the Footswitch and corresponding Footswitch cord to minimize potential tripping hazard.
• In the instance of a cardiac event, disconnect the Crosser iQ™ Ultrasonic CTO Device from the BD Recanalization System and ensure that none of the components of the device are in contact with the patient or user prior to defibrillation.

Potential Adverse Events

Potential patient/device adverse effects which can occur singularly or collectively and may include, but are not limited to, the following:

• Bleeding which may require transfusion or surgical intervention
• Puncture site hematoma, pain and tenderness
• Hemorrhage
• Embolism
• Vessel perforation/dissection
• Guidewire entrapment and/or fracture
• Hypertension/Hypotension
• Infection or fever
• Allergic reaction
• Pseudoaneurysm or fistula Aneurysm
• Acute reclosure
• Thrombosis
• Ischemic events
• Distal embolization
• Excessive contrast load resulting in renal insufficiency or failure
• Excessive exposure to radiation
• Stroke/CVA
• Restenosis
• Repeat catheterization/angioplasty
• Peripheral artery bypass
• Amputation
• Death
• Other bleeding complications at access site

Please consult package insert for more detailed safety information and instructions for use.

BD, the BD logo, Bard, Crosser iQ, GeoAlign, Recon, and BD Recanalization System are trademarks of Becton, Dickinson and Company or its affiliates. © 2021 BD. All rights reserved. Bard Peripheral Vascular, Inc.

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