Contraindications
Target vessels < 2mm in diameter.
Warnings
1. The WavelinQ EndoAVF System is only to be used with the approved components specified above. Do not attempt to substitute non-approved devices or use any component of this system with any other medical device system. Use of the system with other components may interfere with proper functioning of the device.
2. The WavelinQ" catheters are single use devices. DO NOT re-sterilize or re-use either catheter. Potential hazards of reuse include infection, device mechanical failure, or electrical failure potentially resulting in serious injury or death.
3. The WavelinQ EndoAVF System should not be used in patients who have known central venous stenosis or upper extremity venous occlusion on the same side as the planned AVF creation.
4. The WavelinQ EndoAVF System should not be used in patients who have a known allergy or reaction to any drugs/fluids used in this procedure.
5. The WavelinQ EndoAVF System should not be used in patients who have known adverse reactions to moderate sedation and/or anesthesia.
6. The safety and performance of the device via arterial wrist access has not been fully established. The incidence of vessel stenosis or occlusion that occurs in the radial and ulnar arteries after arterial wrist access has not been evaluated.
7. Do not use the device to create an EndoAVF using arterial access via the radial or ulnar artery. The EndoAVF should only be created using brachial artery access.
8. Use caution when performing electrosurgery in the presence of pacemakers or implantable cardioverter defibrillators.
9. Improper use could damage insulation that may result in injury to the patient or operating room personnel.
10. Do not plug device into the electrosurgical pencil with ESU powered on.
11. Keep active accessories away from patient when not in use.
12. Do not permit cable to be parallel to and/or in close proximity to leads of other devices.
13. Do not wrap cable around handles of metallic objects such as hemostats.
14. Consult the ESU User Guide on its proper operation prior to use.
15. Do not use closure devices not indicated to close the artery used for access.
16. Ensure the patient's arm is restrained to minimize movement during device activation; potential hazards of patient arm movement during activation are hematoma or pseudoaneurysm near the fistula site.
17. The puncture site should be closed and hemostasis should be achieved by manual compression per the instructions below. Use of closure devices with the WavelinQ EndoAVF System may be associated with an increased risk of access site complications.
18. The WavelinQ EndoAVF System has only been evaluated for the creation of an AVF between the ulnar artery and concomitant ulnar vein and between the radial artery and concomitant radial vein in the clinical studies described below.
19. Refer to the latest National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for recommendations and considerations for AV access creation in patients on or requiring hemodialysis. For patients expected to have prolonged durations on hemodialysis. a distal to proximal approach to AVF creation provides the best opportunity to preserve vessels for future vascular access sites following the individual patient ESKD Life-Plan.
20. This device is coated with a hydrophilic coating at the distal end of the device for a length of 26.4 cm (10.4 in). Please refer to the AVF Creation 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.
Cautions
1. Only physicians trained and experienced in endovascular techniques, who have received appropriate training with the device, should use the device. Endovascular technique training and experience should include ultrasound vessel access in the arm, guidewire navigation, radiographic imaging, placement of vascular embolization devices (including embolization coils), and access hemostasis.
2. Adhere to universal precautions when utilizing the device.
3. Do not kink, pinch, cut, bend, twist, or pull excessively or with excessive force on any portion of the devices. Damage to the catheter body may cause the device to become inoperable.
4. Avoid sharp bends. This may cause the device to become inoperable.
5. Do not pinch or grasp the catheter with excessive force or with other instruments. This may cause the device to become inoperable.
6. Do not bend the rigid portion of the catheter near the electrode or backstop.
7. Do not touch or handle the active electrode. Electrode dislodgement may occur.
8. Always use the hemostasis valve crosser to assist insertion of the venous catheter through the introducer sheath. Insertion into introducer sheath without hemostasis valve crosser may damage electrode.
9. Do not attempt to remove the hemostasis valve crosser located on the venous device. Device damage or fracture may occur.
