INTELLANAV™OPEN-IRRIGATED Ablation Catheter

INTENDED USE / INDICATIONS FOR USE

The IntellaNav™ OI Catheter, when used with a compatible Radiofrequency Controller and Irrigation Pump, is indicated for:

• Cardiac electrophysiological mapping
• Delivering diagnostic pacing stimuli
• RF ablation of sustained or recurrent type 1 atrial flutter in patients age 18 years or older
• Treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
  

CONTRAINDICATIONS

The IntellaNav OI Catheter is contraindicated for use in patients:

• With active systemic infection;
• With a mechanical prosthetic heart valve through which the catheter must pass;
• Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation;
• Who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach;
• Who are hemodynamically unstable;
• Who have myxoma or an intracardiac thrombus;
• Who have had a ventriculotomy or atriotomy within the preceding eight weeks;
• Who have had a Patent Foramen Ovale (PFO) occlusion device.
  

WARNINGS

Cardiac mapping and ablation procedures should be performed only by physicians thoroughly trained in invasive cardiology and in the techniques of open-irrigated RF powered catheter mapping and ablation, and in the specific approach to be used, in a fully-equipped electrophysiology lab.

• Carefully read all ancillary device instructions prior to use. Observe all contraindications, warnings, and precautions noted in these directions. Failure to do so may result in patient complications.

Note: The IntellaNav OI Catheter is not designed to be compatible with the Maestro 3000® RF Cardiac Ablation System.

• Before using, inspect the IntellaNav OI Catheter for any defects or physical damage, including electrical insulation on the cables and the catheter shaft that may cause patient and/or user injury if the catheter is used. Do not use defective or damaged devices. Replace damaged device(s) if necessary.
• No modification of this equipment is allowed.
• Contents are supplied STERILE using an EO process and should be used by the ‘‘Use By’’ date on the device package. Do not use the device if past the ‘‘Use By’’ date. Do not use if sterile barrier is damaged as use of non sterile devices may result in patient injury. If damage is found, call your BSC representative.
• Catheter ablation procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as an increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps have been taken to minimize this exposure. Careful consideration must therefore be given for this use of the device in pregnant women. 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. 
• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
• Start the initial RF application at low power and carefully follow the power titration and the correlating flow rate procedures as specified in the instructions for use. A drop in impedance may be an indicator of lesion creation. Too rapid an increase in power during ablation, increasing power with a decrease in impedance, ablating at high power (> 30 W) or insufficient flow rate may lead to perforation caused by steam pop, arrhythmias, damage to adjacent structures, and/or embolism. Collateral tissue damage is a possibility when using the catheter at the upper power setting (50 W) or durations longer than 60 seconds or with a decrease in impedance without moving the catheter tip. Power should be increased to > 30 W only if lower energies do not achieve the intended result.
• Patients undergoing an atrial flutter ablation are at risk for complete Atrioventricular (AV) block which requires the implantation of a temporary and/or permanent pacemaker.
• There are no data to support the safety and effectiveness of this device in the pediatric population.• Because the long term effects of exposure to ionizing radiation are unknown, careful consideration should therefore be given to pregnant women and prepubescent children. 
• Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter that may result in embolism.
• During energy delivery, the patient should not be allowed to come in contact with grounded metal surfaces to minimize the potential for electrical shock.
• Electrodes and stimulating devices can provide paths of high frequency current. The risk of burns can be reduced but not eliminated by placing the electrodes as far away as possible from the ablation site and the Dispersive Pad. Protective impedances may reduce the risk of burns and permit continuous monitoring of the electrocardiogram during energy delivery.
• Before use, ensure irrigation ports are patent by infusing heparinized normal saline through the catheter tubing. Patency of irrigation ports is important to maintain cooling function and minimize risks of coagulum and char that may result in embolism as well as perforation caused by steam pop.
• Due to the design of the IntellaNav OI Catheter tip, the velocity of fluid exiting the irrigation ports may change based on rate and pressure of flushing. As long as there is fluid exiting each port, regardless of the velocity, the catheter is functioning as designed and may be used. However, if any irrigation port has no flow (or extremely low flow compared to adjacent ports) despite attempts to flush the irrigation port, do not insert the catheter in the patient as there may be potential risk of embolism.
• In the presence of anticoagulation, there may be an increased risk of bleeding from all causes.
• Electrical recording or stimulation equipment must be isolated. Current leakage from any electrical equipment that is connected to the patient must not exceed 10 microamps for intracardiac electrodes. Care must be taken to ensure that any equipment used in connection with the BSC catheters be type CF, be defibrillation proof, and meet IEC 60601-1 electrical safety requirements, and comply with all local regulatory requirements for specified intended use to reduce the potential risk of inadvertent electrical shock.
• Maximum Catheter Rated Voltage: 150 Vrms (212 Vpk).• Stimulation of cardiac tissues caused by pacing stimulus and/or RF energy may lead to inadvertent induction of arrhythmias.  These arrhythmias may require defibrillation that could also result in skin burns.
• Warnings for patients with implantable pacemakers and Implantable Cardioverter/Defibrillators (ICDs):
  • Temporarily adjust tachytherapy settings of an ICD per the manufacturer guidelines during RF ablation as the device could reset or deliver inappropriate defibrillation therapy resulting in patient injury. The ICD could be damaged by the ablation procedure. Interrogate the device fully after the ablation per the manufacturer guidelines and reactivate the ICD’s pre-operative pacing, sensing, and therapy parameters after the ablation procedure.
  • Temporarily reprogram the pacemaker per the manufacturer guidelines during RF ablation to a non tracking pacing mode if pacing is likely to be required during the ablation. The pacemaker could be damaged by the ablation procedure. Interrogate the device fully after the ablation per the manufacturer guidelines and reprogram to preoperative sensing and pacing parameters.
  • 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.
  • Fluoroscopic guidance and care must be taken during catheter advancement, manipulation, and withdrawal to avoid lead dislodgment.
  • Monitor pre- and post-measurements for sensing and pacing thresholds and impedances to determine the integrity of the lead-patient function.
• During RF ablation, care must be taken not to deliver RF energy on or near the coronary artery even on the right side of the heart, as the resulting myocardial injury can be fatal.
• 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.
• At no time should an IntellaNav OI Catheter be advanced or withdrawn when resistance is felt, without determining the cause. Valve damage, vascular and/or cardiac perforation is a risk with any intracardiac catheter.
• 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 over torqued and/or positioned in the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.
• In the event of a suspected failure of the integrity of fluid flow through the IntellaNav OI Catheter or if there is a rapid temperature rise of greater than 15° C noted on the RF Controller, the procedure should be stopped, and the IntellaNav OI Catheter withdrawn to reduce the risk of steam pop that could result in perforation. Both the IntellaNav OI Catheter and the Irrigation Tubing Set should be replaced. The replacement catheter and tubing set must be primed outside the body prior to insertion to reduce the risk of air embolism.
• Prior to the procedure, always identify the patient’s risk of volume overload.  Monitor the patient’s fluid balance throughout the procedure and after the procedure to avoid fluid volume overload. Some patients may have factors that reduce their ability to handle the volume overload, making them susceptible to developing pulmonary edema or heart failure during or after the procedure. Patients with congestive heart failure or renal insufficiency, and the elderly are particularly susceptible.
• Excessive curves or kinking of the IntellaNav OI Catheter may damage internal wires and components, including the cooling lumen. This damage may affect steering performance and may cause patient injury. • Manual bending and/or twisting of the distal curve can damage the steering mechanism and cooling lumens and may cause IntellaNav OI Catheter failure and patient injury.
• Do not scrub the tip electrode as this may result in irrigation port(s) occlusion and may lead to IntellaNav OI Catheter failure and/or patient injury.
• Use both fluoroscopy and electrograms to monitor the advancement of the IntellaNav™ OI Catheter to the area of the endocardium under investigation to avoid conduction pathway injury, cardiac perforation or tamponade
• Do not deliver RF energy with the IntellaNav OI Catheter outside the target site. The RF Controller can deliver significant electrical energy and may cause patient injury.
• In the event of RF Controller cut-off (impedance or temperature), the IntellaNav OI Catheter must be withdrawn and the tip electrode cleaned of coagulum before RF energy is reapplied. Ensure that all of the irrigation holes are patent prior to reuse to reduce the risk of embolism and/or perforation.
• Verify effective contact between the patient and the Dispersive Pad whenever the patient is repositioned as patient movement may disrupt Dispersive Pad contact resulting in patient injury and/or extended procedure times.• Inspect irrigation saline for air bubbles and remove any air bubbles prior to its use in the procedure. Air bubbles in the irrigation saline may cause embolism.
• Always verify that the Irrigation Tubing Set, IntellaNav OI Catheter and all connections have been properly cleared of air prior to inserting the catheter into the vasculature. Air entrapped in the tubing and IntellaNav OI Catheter can cause potential injury or cardiac arrest. The operator is responsible for removing all air from the system.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life-threatening adverse events and ablation must be done with extreme caution.
• This IntellaNav OI Catheter is not intended to be used for internal cardioversion. Doing so may result in perforation, arrhythmias, embolism, thrombus and/or patient death.
• 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.
• If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the atrial flutter procedure, there should be a low threshold to perform a Transesophageal Echocardiogram (TEE) prior to the procedure to confirm absence of mural thrombus and/or thrombus in the left atrial appendage.
• Guiding catheters and/or long introducer sheaths present the potential for thromboembolic events. Pre-flush and maintain lumen patency with heparinized intravenous infusion.
• Do not wipe the IntellaNav OI Catheter with organic solvents such as alcohol, or immerse the handle cable connector in fluids. This may result in electrical or mechanical catheter failures. It may also result in an allergic reaction from the patient.
• Use only sterile saline and gauze pad to clean the tip.
• Irrigation flow during RF ablation may distort distal tip electrogram recordings due to the signal conductivity of the external cooling solution. Careful monitoring of additional intracardiac electrograms during RF application is recommended to reduce the possibility of inadvertent injury to adjacent structures if appropriate. Higher power coupled with higher flow rates may exacerbate the distortion of the EGM signal recordings.

PRECAUTIONS

• The IntellaNav OI Catheter is designed for use with a compatible RF Controller, Irrigation Pump and Irrigation Tubing Set that meets the catheter flow rate requirements, a compatible Mapping System, and compatible Connection Box.
• Do not use the temperature sensor to monitor tissue temperature. The temperature sensor located within the electrode will not reflect either electrode-tissue interface or tissue temperature due to the cooling effects of the saline irrigation of the electrode. 
• Electromagnetic Interference (EMI) produced by the IntellaNav OI Catheter when used in conjunction with the RF Controller during normal operation may adversely affect the performance of other equipment.
• The IntellaNav OI Catheter is not intended to be used with a RF generator output setting exceeding 50 W or 212 Volts peak.
• Verify the RF Controller is in the control mode which will deliver the amount of power specified by the power setting unless the measured temperature exceeds the temperature setting. Temperature controlled RF delivery may be affected by the cooling effects of the saline irrigation of the electrode. For example, the Maestro 4000™ RF Cardiac Ablation Controller has these settings in the power control mode.
• Do not use the IntellaNav OI Catheter in the proximity of Magnetic Resonance Imaging (MRI) equipment because the MRI equipment may adversely impact the function of the RF Controller which may adversely impact the MRI equipment’s image quality.
• Use only Dispersive Pads which meet or exceed IEC 60601-1/ IEC 60601-2-2 requirements and follow the Dispersive Pad manufacturer’s instructions for use. The use of Dispersive Pads which meet ANSI/AAMI requirements (HF18) is recommended.
• Apparent low power output, high impedance reading or failure of the equipment to function correctly at normal settings may indicate faulty application of the Dispersive Pad or failure of an electrical lead.
• The IntellaNav™ OI Catheter is highly torqueable. Avoid overtorquing. Over-rotating the handle and catheter shaft may cause damage to the distal tip or catheter assembly. Do not rotate the handle and catheter shaft more than one and one-half (1½) full rotations (540°). If the desired catheter tip position is not achieved, adjust the catheter’s curve to disengage the catheter tip from the heart wall, before resuming rotation of the handle and catheter shaft.
• Do not insert or withdraw the catheter without straightening the catheter tip (returning the steering lever to neutral position). 
• Electrophysiology catheters and systems are intended for use only in radiation shielded rooms due to electromagnetic compatibility requirements and other hospital safety guidelines. 
• Ensure that the cable/catheter connection remains dry throughout the procedure. 
• The risk of igniting flammable gases or other materials is inherent in electrosurgery. Precautions must be taken to restrict flammable materials from the electrosurgical suite. 
• Patients undergoing a long irrigated ablation procedure have the potential for greater anticoagulation and therefore Activated Coagulation Time (ACT) should be monitored closely. 
• Fibrin may accumulate in or on the sheath/catheter assembly during the procedure. Aspirate when removing the dilator or catheter.
  

Potential ADVERSE EVENTS

Potential adverse events which may be associated with catheterization and ablation include:

Allergic reaction (including anaphylaxis)
Angina
Arrhythmias (new or exacerbation of existing arrhythmias)
Cardiac perforation
Cardiac/respiratory arrest 
Catheter entrapment 
Cerebrovascular accident (CVA) 
Chest discomfort 
Conduction pathway injury 
Complete heart block (transient/permanent) 
Complications of sedative agents/anesthesia 
Congestive heart failure 
Death
Edema 
Effusion (pericardial/pleural) 
Embolism (venous/arterial) (e.g., air embolism, cerebrovascular accident, Myocardial Infarction (MI), pulmonary embolism) 
Esophageal Injury
Exacerbation of existing conditions
Fistula (arterial-venous/atrio-esophageal)
Fluid volume overload  
Gastroparesis/Gastrointestinal (GI) events
Hematoma 
Hemorrhage 
Hemothorax
Hypertension 
Hypotension 
Inadvertent injury to adjacent structures
Infection 
Lead dislodgement 
Myocardial infarction 
Nerve injury (phrenic/vagus) 
Pericarditis 
Pleuritis 
Pneumothorax 
Pseudoaneurysm 
Pulmonary/pedal edema 
Pulmonary vein stenosis
Radiation exposure 
Renal insufficiency/failure 
Residual Atrial Septal Defects (ASD)
Skin burns (radiation/defibrillator/cardioverter) 
Tamponade 
Transient Ischemic Attack (TIA) 
Thrombosis  
Valvular damage 
Vasospasm 
Vasovagal reactions 
Vessel trauma (perforation/dissection/rupture)

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