INTELLATIP MIFI™ XP Temperature Ablation Catheter
Indications, Safety, and Warnings
INDICATIONS FOR USE
The BSC IINTELLATIP MIFI™ XP Catheter is indicated for use with the BSC Maestro 3000® Controller, and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
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.
Before operating the device, read these warnings carefully: Peri-procedural anti-coagulation therapy is at the discretion of the physician, however, patients with a history of thromboembolic events may require therapeutic anti-coagulation therapy, 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. 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. Care must be taken to ensure that any equipment used in connection with the BSC catheters, be type CF, be defibrillation proof, meet EN 60601-1 electrical safety requirements, and comply with all local regulatory requirements for the specified intended use. Maximum INTELLATIP MIFI XP Catheter Rated Voltage: 178 Vrms (251 Vpk) No modification of this equipment is allowed. 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 atrial flutter 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. Do not pass the INTELLATIP MIFI XP 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.
Observe these precautions, before using the device: Do not attempt to operate the Controller before thoroughly reading the appropriate BSC high power Cardiac Ablation Controller & Accessories Operator’s Manuals. The INTELLATIP MIFI XP Catheters are intended for use with the BSC Controller and accessories only. The INTELLATIP MIFI XP 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 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. Cardiac mapping and ablation procedures should be performed only by physicians thoroughly trained in the techniques of RF Powered catheter mapping and ablation in a fully-equipped electrophysiology laboratory. 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 filtering must be used to allow continuous monitoring of the surface electrocardiograms (ECG) during RF power applications. When using the INTELLATIP MIFI XP Catheter, it is required that two Dispersive Indifferent Patch (DIP) Electrode 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 DIP electrode will not allow the operator to fully access the higher power capabilities of the Controller. Placement of the DIP electrodes 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 DIP electrodes or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication. Regularly inspect and test re-usable cables and accessories.
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, complete heart block (transient/permanent), cerebral vascular accident, chest pain/discomfort, 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, pulmonary edema, pseudoaneurysm, radiation exposure, sinoatrial node damage, skin burn (defibrillator/cardioverter/radiation), tamponade, transient ischemic attack (TIA), valvular damage, vasovagal reactions, visual blurring.
92289667 (Rev. A)