Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Cardiac electrophysiology mapping and for use with a compatible RF generator for creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.
Do not use this device:
- in patients with active systemic infection;
- via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch; or
- in patients with aortic valve replacement via the retrograde transaortic approach.
WARNINGS AND PRECAUTIONS
- Do not ablate from within a coronary artery as the resulting myocardial injury can be fatal. Adequate fluoroscopic visualization is necessary during the transaortic approach to avoid placement of the ablation catheter in the coronary vasculature.
- Stroke or myocardial infarction may occur in patients undergoing left-sided ablation procedures. Patients should be closely monitored during the post-ablation period for clinical manifestations of embolic events.
- Precautions in patients with implantable pacemakers and implantable cardioverter/defibrillators (ICDs):
– Deactivate ICDs as they could discharge and injure the patient or be damaged by the ablation procedure
– Have temporary external sources of pacing and defibrillation available
– Do not apply RF energy directly to a lead or to tissue immediately in contact with a lead because it could potentially damage the lead or lead function
– Perform a complete analysis of the implanted device function after ablation
- Complete AV block can occur when ablating septal accessory pathways or in the treatment of AVNRT. Closely monitor AV conduction during RF energy delivery and immediately terminate energy delivery if partial or complete AV block is observed.
- Minimize X-ray exposure - Significant X-ray exposure can result in acute radiation injury as well as dose-related risk for somatic and genetic effects. Take all appropriate measures to minimize X-ray exposure to both patients and clinical staff.
- X-ray exposure to children - The long-term risk of protracted fluoroscopy has not been established. Therefore, careful consideration must be given for the use of the device in prepubescent children.
- Pregnancy - Careful consideration should be given to the use of this device in pregnant women because of the dose-related risk for somatic and genetic effects of x-ray exposure.
- Training - Cardiac ablation procedures should be performed only by appropriately trained personnel in a fully equipped electrophysiology laboratory.
Instructions for Use - Do not attempt to operate the Livewire Catheter before completely reading and understanding the applicable directions for use.
Long-term risks of RF ablation - The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
Insertion and Withdrawal - Do not insert or withdraw the catheter without straightening the catheter tip, as confirmed via fluoroscopy.
Use with Sheaths
- Do not deflect the catheter tip while it is constrained within a sheath.
- Do not deflect the catheter tip of the bi-directional models when it is extended less than two inches (5cm) beyond the tip of a sheath.
Precautions During Catheter Use
- The patient should not contact grounded metal surfaces. Use only isolated amplifiers, pacing equipment, and ECG equipment or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 microAmps (μA) under any circumstances.
- Do not use excessive force to advance or withdraw the catheter. Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.
- Use both fluoroscopy and electrograms to monitor the advancement of the catheter to the area of the endocardium under investigation to avoid vascular or cardiac damage.
Precautions During Ablation
- Do not increase power before checking for lead connection and appropriate dispersive electrode application. Effective contact between the patient and the dispersive electrode must be verified whenever the patient is repositioned.
- Do not deliver RF energy with catheter outside the target site. The RF generator can deliver significant electrical energy and may cause patient or operator injury.
- Avoid use of electrodes and probes of monitoring and stimulating devices which could provide paths for high frequency current. Reduce the burn hazard by placing the electrodes and probes as far away as possible from the ablation site and the dispersive electrode.
- In the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip electrode cleaned of coagulum before RF current is re-applied. Use only sterile saline and gauze pad to clean the tip.
- Do not scrub or twist the tip electrode as damage may cause catheter failure or patient injury.
- Discontinue ablation immediately and replace catheter if tip temperature fails to rise during ablation (temperature sensing model).
- The temperature sensing model of the catheter measures electrode tip temperature, not tissue temperature. If the generator does not display temperature (temperature sensing model), verify that the appropriate cable is plugged into the generator. If temperature still is not displayed, there may be a malfunction in the temperature sensing system which must be corrected prior to applying RF power.
POTENTIAL ADVERSE EVENTS
Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including complete heart block requiring pacemaker. Please refer to the Instructions for Use for a complete list.
Last Updated: January 02, 2019
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