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INTELLANAV™ XP Ablation Catheter and INTELLANAV MIFI™ XP Ablation Catheter

Indications, Safety, and Warnings


INDICATIONS FOR USE

The Boston Scientific Corporation INTELLANAV XP and MiFi XP Catheters are indicated for use with the BSC high power Cardiac Ablation Controllers (Maestro 3000 Controller and Maestro 4000 Controller) and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older. The BSC high power Cardiac Ablation Controllers and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

CONTRAINDICATIONS

Do not use this device: in patients with active systemic infection; via the transseptal approach in patients with left atrial thrombus or myxoma; via the retrograde approach in patients with aortic valve replacement.

WARNINGS

Peri-procedural anti-coagulation therapy is at the discretion of the physician, however, patients with a history of thromboembolic events may require 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 therefore be given to pregnant women and pre-pubescent children.

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.

PRECAUTIONS

Do not place the distal end of the catheter near magnets.

Do not attempt to operate the Controller before thoroughly reading the appropriate BSC high power Cardiac Ablation Controller & Accessories Operator’s Manuals.

The INTELLANAV XP and MiFi XP Catheters are 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 times the full rotation (540 degrees). 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.

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.

Excessive bending or kinking of the catheter shaft may damage internal wires. Manual pre-bending of the distal curve can damage the steering mechanism and may cause patient injury.

Unlike with conventional catheters, a sudden rise in system impedance is not an indication of coagulum formation. Therefore, to minimize coagulum, it is recommended that the catheter periodically be removed and the distal tip cleaned after each line of block.

Adequate signal filtering must be used to allow continuous monitoring of the surface electrocardiograms (ECGs) and intracardiac electrograms (EGMs) during RF power applications.

When using the INTELLANAV XP or MiFi XP Catheter, it is required that two Dispersive Pads satisfying the requirements of IEC 60601-1/IEC 60601-1-2 be used as the ablation return electrodes or skin burns may result. Use of only one Dispersive Pad will not allow the operator to fully access the higher power capabilities of the Controller.

Placement of the Dispersive Pads on the thigh could be associated with higher impedance, which could result in automatic RF power shut-off.

During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces.

Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the Dispersive Pads or failure of an electrical lead.

Do not increase power before checking for obvious defects or misapplication.

Electromagnetic interference (EMI) produced by the Cardiac Ablation Controller during the delivery of RF power may adversely affect the performance of other equipment. 

POTENTIAL ADVERSE EVENTS

Potential adverse events (in alphabetical order), that may be associated with cardiac catheterization and ablation include, but are not limited to: allergic reaction (including anaphylaxis), angina, arrhythmias, arterial or pulmonary embolism, arterial-venous fistula, atrioventricular node damage (transient/permanent), back pain and/or groin pain, cardiac perforation, cardiac respiratory arrest, catheter entrapment, cerebral vascular accident, chest pain/discomfort, complete heart block (transient/permanent), complications of sedative agents (e.g. aspiration pneumonia), death, effusion (pericardial/pleural), hematoma/bruising, hemoptysis, hemorrhage, hemothorax, hypotension, infection, myocardial infarction, nerve palsy or weakness, pericarditis, phrenic nerve damage/diaphragmatic paralysis, pleurisy, pneumothorax, pseudoaneurysm, pulmonary edema, radiation exposure, sinoatrial node damage, skin burn (defibrillator/cardioverter/radiation), tamponade, transient ischemic attack (TIA), valvular damage, vasovagal reactions, visual blurring.

(Rev A)

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