Abbott Advisor FL Circular Mapping Catheter, Sensor Enabled, Instructions For Use Manual

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Advisor™ FL Circular Mapping Catheter, Sensor Enabled™
Instructions for Use
Description
Advisor™ FL Circular Mapping Catheters, Sensor Enabled™ are steerable, flexible, insulated electrophysiology catheters constructed of thermoplastic
elastomer material and noble metal electrodes. For both bi-directional and uni-directional catheters, the shaft curvature is manipulated by the control
mechanism located on the handle at the catheter’s proximal end. To adjust the curve on the uni-directional catheter, push or pull the thumb control located
on the handle. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented
counter-clockwise as viewed from the handle. See label for outer diameter and specific loop configuration.
Indications for Use
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac
signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information.
The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is
indicated for use as an adjunct to fluoroscopy.
Contraindications
 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 via retrograde approach.

This device is not recommended for use in the ventricles.
 The device is not intended for transcatheter ablation.
 This device should not be used with patients with active systemic infections.
Warnings
 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.
Caution
 United States law restricts this device to sale by or on order of a physician.
 Read directions prior to use.
Precautions
 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. Compatible
navigation and visualization systems may be used in conjunction with fluoroscopy.

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.
Directions
1. Inspect the package prior to use. Do not use if the package is open, damaged, or expired.
2. Remove the catheter from its packaging.
-
Completely remove the tray from the pouch.
- Remove the handle retainer from the tray before removing the catheter. See Figure 1 in the Packaging and Shelf-Life section.
- To prevent potential damage to the loop, lift the catheter up and out of the tray.
3. Inspect the electrodes and catheter carefully for integrity and overall condition.
4. Insert the distal tip section of catheter into an 8F minimum introducer (not included) using the loop straightener:
-
Prior to insertion, deflect catheter shaft to straight position.
- Slide the loop straightener over the distal loop section of catheter.
- Insert the loop straightener with the catheter distal end into and through the hemostasis valve of the introducer (not included).
- Insert catheter through the hemostasis valve.
- After the catheter is inside the introducer, pull the loop straightener out from the hemostasis valve.
5. Never manipulate the loop or deflectable section of the shaft while within the introducer.
6. Connect to compatible systems using the appropriate cable. Refer to the cable's instructions for use.