IMPORTANT SAFETY INFORMATION
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The catheter is contraindicated for patients with prosthetic valves and patients with left atrial thrombus or myxoma, or interatrial baffle or patch via transseptal approach. This device should not be used with patients with active systemic infections. The catheter is contraindicated in patients who cannot be anticoagulated or infused with heparinized saline.
This device should be used by or under the supervision of physicians thoroughly trained in the techniques of percutaneous electrophysiology studies. Cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as 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. Careful consideration must therefore be given for the use of this catheter in pregnant women. Catheter entrapment within the heart or blood vessels is a possible complication of electrophysiology procedures. Vascular perforation or dissection is an inherent risk of any electrode placement. Careful catheter manipulation must be performed in order to avoid device component damage, thromboembolism, cerebrovascular accident, cardiac damage, perforation, pericardial effusion, or tamponade. Risks associated with electrical stimulation may include, but are not limited to, the induction of arrhythmias, such as atrial fibrillation (AF), ventricular tachycardia (VT) requiring cardioversion, and ventricular fibrillation (VF). Do not use force to advance or withdraw catheter when resistance is encountered. Do not immerse the proximal handle or cable connector in fluids; electrical performance could be affected. Catheter materials are not compatible with magnetic resonance imaging (MRI). This device is intended for one time use only. Do not reprocess or reuse. Reuse can cause device failure, patient injury, and/or the communication of infectious disease(s) from one patient to another.
United States law restricts this device to sale by or on order of a physician. Read directions prior to use.
Maintain an activated clotting time (ACT) of greater than 300 seconds at all times during use of the catheter. This includes when the catheter is used in the right side of the heart. To prevent entanglement with concomitantly used catheters, use care when using the catheter in the proximity of the other catheters. Maintain constant irrigation to prevent coagulation on the distal paddle. Inspect irrigation tubing for obstructions, such as kinks and air bubbles. If irrigation is interrupted, remove the catheter from the patient and inspect the catheter. Ensure that the irrigation ports are patent and flush the catheter prior to re-insertion. Personnel handling the electrophysiology catheter should wear gloves. To maintain optimal patient safety and electrode catheter integrity, do not wipe this catheter with alcohol. Excessive bending or kinking of the catheter may cause damage to the catheter. Use care to isolate any unused connector pins of the electrogram cable. This will reduce the chances of developing accidental current pathways to the heart. Always straighten the catheter before insertion or withdrawal. Catheter advancement must be performed under fluoroscopic guidance to minimize the risk of cardiac damage, perforation, or tamponade. Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired curve. Do not use if the catheter does not hold its curve and/or if any of the irrigation ports are blocked.