Indications, Safety, and Warnings
INTENDED USE/INDICATIONS FOR USE
The IntellaNav ST Catheter, when used with a compatible radiofrequency controller, is indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia.
CONTRAINDICATIONS AND RESTRICTIONS
The IntellaNav ST Catheter is intended to treat patients 18 years or older that have cardiac arrhythmias.
The use of the device is contraindicated in patients:
- with active systemic infection.
- who have had a ventriculotomy or atriotomy within the preceding eight weeks.
- via the transeptal approach in patients with left atrial thrombus of myxoma, or interartrial baffle or patch.
- via the retrograde transaortic approach in patients with aortic valve replacement.
- who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach.
Before operating the device, read these warnings carefully:
- Peri-procedural anticoagulation therapy is at the discretion of the physician; however, patients with a history of thromboembolic events may require the therapeutic anticoagulation therapy, pre-, during and post ablation to reduce the incidence of major complications.
- Because the long-term effects of exposure to ionizing radiation are unknown, careful consideration should be given to pregnant patients.
- Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF signals. It is important to:
a. Retain temporary external sources of pacing available during ablation
b. Reprogram the pacing system temporarily to minimum output or 000 mode to minimize risk of inappropriate pacing.
c. Exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads.
d. Perform complete pacing system analysis on all patients after ablation. Implanted cardioverter / defibrillators should be deactivated during delivery of RF power.
- Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. The potential for catheter entrapment may be increased when the catheter is positioned in the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissues.
- Maximum IntellaNav™ ST Catheter Rated Voltage: 178 Vrms (251 Vpk).
- In the presence of anticoagulation, there may be an increased risk of bleeding from all causes.
- If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the procedure, there should be a low threshold to perform a transesophageal echocardiogram (TEE) prior to the procedure to confirm absence of thrombus in the left atrial appendage based on an individual patient-centered medical assessment of peri-procedural stroke risk.
- Do not pass the IntellaNav ST Catheter through any prosthetic heart valve (mechanical or tissue), as this may cause entrapment of the catheter and/or damage to the prosthetic heart valve, resulting in valvular insufficiency and/or premature failure of the prosthetic valve.
- Do not deliver RF energy when the tip electrode is withdrawn or partially withdrawn into a sheath, to minimize the risk of char or coagulum formation.
- There are no data to support the safety and effectiveness of this device in the pediatric population.
- Ablation in contact with any other electrodes alters the function of the catheter and can lead to thrombus, coagulum, or char formation that may result in embolism.
Observe these precautions, before using the device:
Do not place the distal end of the catheter near magnets. Magnetization of the catheter may result in degradation of magnetic tracking precision. Such degradation may be manifested by an unstable or complete loss of rendering of the position and/or orientation of the catheter by a magnetic tracking system. If this occurs, the catheter should be replaced.
The IntellaNav ST Catheters are intended for use with the BSC RF Controllers and accessories only.
- Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be done under fluoroscopic guidance.
- Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
- The catheter impedance LED display of the RF Controller should be continuously monitored during RF power delivery. If a sudden rise in impedance is noted, power delivery should be discontinued. The catheter should be removed and the distal tip of the catheter cleaned to eliminate any coagulum.
- Adequate signal filtering must be used to allow continuous monitoring of the surface electrocardiograms (ECGs) during RF power applications.
- Do not increase power before checking for obvious defects or misapplication.
- Electromagnetic interference (EMI) produced by the RF Controller during the delivery of RF power may adversely affect the performance of other equipment.
The following potential adverse events (in alphabetical order) may be associated with cardiac catheterization and cardiac ablation procedures. The frequency and severity of these adverse events can vary, and may necessitate additional medical intervention, including surgery. These include but are not limited to:
- Allergic reaction (including anaphylaxis)
- Arrhythmias (new or exacerbation of existing arrhythmias)
- Atrioventricular node damage (transient or permanent)
- Cardiac or respiratory arrest
- Catheter entrapment or entanglement
- Chest pain or discomfort
- Complete heart block (transient or permanent)
- Complications of sedative agents (e.g. aspiration pneumonia)
- Damage to vessel intima or cardia ultrastructures
- Electric shock
- Embolism, venous, arterial (i.e., air, cerebrovascular accident, myocardial infarction, pulmonary embolism)
- Fistula (arterial, venous or atrio-esophageal)
- Hematoma or ecchymosis
- Myocardial infarction
- Nerve palsy or weakness
- Pericardial or pleural effusion
- Pericarditis or pleuritis
- Phrenic or intercostal nerve damage
- Pulmonary edema
- Radiation exposure
- Sinus or AV node injury
- Skin burn (defibrillator, cardioverter or radiation)
- Stenosis-pulmonary vein
- Stroke or cerebral vascular event
- Transient ischemic attack (TIA)
- Valvular damage
- Vasovagal reaction
- Vessel occlusion
- Visual blurring
92222790 (Rev A)