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Caution
•
Do not attempt to use the device before completely reading and understanding the instructions
for use.
Description
T
he FlexAbility™ Ablation Catheter is a sterile, single use catheter with a 7.5 F shaft and an 8 F distal
section. It is constructed of thermoplastic elastomer material and noble metal electrodes. The catheter
has a novel flexible tip electrode. It has a fluid lumen connected to open conduits at the flexible tip
electrode for saline irrigation during the ablation procedure. For both bi-directional and uni-directional
catheters, the tip curvature is manipulated by the control mechanism located on the handle at the
catheter's proximal end. To adjust the curve of the distal tip on the uni-directional catheter, push or
pull the thumb control located on the handle. To adjust the curve of the distal tip on the bi-directional
catheter, use the actuator to deflect the catheter in either direction. FlexAbility™ Ablation Catheters
are available in eight distal curve configurations listed in the table below. The curve is identified on the
catheter label.
Catheter
FlexAbility™ Ablation Catheter
FlexAbility™ Ablation Catheter
The catheter connects to a compatible RF cardiac ablation generator and irrigation pump. Refer to the
Operator's Manual packaged with the generator and the pump for a description of the generator and
pump operations and related accessories.
Indications for Use
The FlexAbility™ Ablation Catheter is intended for use with the compatible irrigation pump and a
compatible RF cardiac ablation generator. The catheter is intended for creating focal endocardial
lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of
arrhythmias.
Contraindications
The FlexAbility™ Ablation Catheter is contraindicated for:
•
Patients with active systemic infection,
•
Patients with prosthetic valves,
•
Patients with intracardiac thrombus or myxoma, or interatrial baffle or patch via transeptal
approach, and
•
Patients unable to receive heparin or an acceptable alternative to achieve adequate
anticoagulation.
Warnings
•
Cardiac ablation procedures should be performed only by physicians thoroughly trained in the
techniques of radiofrequency catheter ablation in a fully equipped electrophysiology laboratory.
•
The temperature data transmitted by the sensor in this catheter is representative of the irrigated
electrode only and does not provide tissue temperature data.
•
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. The long-term risk of protracted fluoroscopy has not
been established. Therefore, careful consideration must be given for the use of the device in
pregnant women and prepubescent children.
•
Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF
signals. It is important to: a) have temporary external sources of pacing and defibrillation
available during ablation, b) deactivate Intracardiac Defibrillators (ICDs) as they could
discharge and injure the patient or be damaged by the ablation procedure, c) exercise extreme
caution during ablation when in close proximity to permanent pacing or defibrillation leads, and
d) perform complete implantable device system analysis on all patients after ablation.
•
Caution should be taken when placing lesions in the proximity of the specialized conduction
system.
•
The long-term risks of RF ablation lesions have not been established, particularly with respect
to lesions placed in proximity to the specialized conduction system.
•
Ablation within and in close proximity to the coronary arterial vasculature has been associated
with myocardial infarction and death.
•
In accordance with your hospital's protocol, monitor the patient's fluid balance throughout the
procedure to avoid fluid overload.
•
Always verify that the tubing and catheter have been properly cleared of air prior to inserting the
catheter into the vasculature since entrapped air can cause potential injury or fatality.
•
Catheter materials are not compatible with magnetic resonance imaging (MRI).
•
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 cardiac damage, perforation, or
tamponade.
•
Do not use force to advance or withdraw catheter when resistance is encountered.
•
When using an electrophysiology (EP) recording system, the equipment must be front-end
isolated, or have an isolated patient cable.
•
Ablation along the caval line may injure the right phrenic nerve.
•
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.
Precautions
•
If the Cool Point™ Irrigation Pump alarm sounds, RF energy will be terminated. Communication
and fluid flow must be evaluated. Inspect irrigation tubing for obstructions, such as kinks and
air bubbles. Remove the catheter from the patient and inspect the catheter and the electrodes.
If necessary, clean the electrodes with a sterile saline saturated gauze pad. Ensure that the
irrigation ports are patent and flush the catheter prior to re-insertion.
•
The catheter impedance display of the cardiac ablation generator should be continuously
monitored during RF power delivery. If a sudden rise in impedance is noted that does not
exceed the preset limit, or a steam pop is observed, power delivery should be manually
discontinued. Clinically assess the situation. If necessary, the catheter should be removed from
the patient and the distal tip of the catheter cleaned to eliminate any coagulum. If the catheter
has defects, exchange it for a new one. Make sure fluid flows from the irrigations ports before
reinserting into the patient. Relocate the catheter and attempt another RF application.
•
There is a possibility of higher incidences of steam pops at power levels exceeding 40 watts and
increased collateral damage when maximum power settings (50 watts) are used. Power should
be increased to these levels only if lower energies do not achieve the intended result.
•
Catheter advancement must be performed under fluoroscopic guidance in conjunction with
internal electrograms and impedance monitoring to minimize the risk of cardiac damage,
perforation or tamponade.
•
Always straighten the catheter before insertion or withdrawal.
•
Always maintain constant irrigation to prevent coagulation within and around electrodes.
•
Do not use if 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.
•
Excessive bending or kinking of the catheter may cause damage to the catheter. Manual pre-
bending of the distal curve can damage the steering mechanism and may cause patient injury.
•
Irrigated ablation systems have been shown to create larger lesions than standard
radiofrequency ablation catheters. Care should be taken when ablating near electrically
vulnerable, thin-walled or other arterial structures.
•
Adequate filtering of mapping systems must be used to allow continuous monitoring of the
surface or intracardiac electrocardiograms during radiofrequency power applications.
Monitoring systems incorporating high frequency current-limiting devices are recommended.
•
Needle monitoring electrodes are not recommended.
•
Do not immerse the proximal handle or cable connectors in fluids; electrical performance could
be affected.
•
Position connecting cables such that contact with the patient and other electrical leads is
avoided.
•
If irrigation flow is interrupted, immediately inspect and re-flush the catheter outside of the
patient. Re-establish irrigation flow prior to placing catheter in the body.
•
Do not attempt ablation without using the Cool Point™ Irrigation Pump.
•
Do not twist or pull the distal electrode. Excessive force may loosen the electrode from the
catheter shaft.
•
After use, dispose of product and packaging in accordance with hospital, administrative, and/or
local government policy.
•
Do not expose the catheter to organic solvents such as alcohol.
Directions
1.
Verify the generator and related accessories are set up per the diagram in the RF generator
Operator's Manual. Do not connect the 1641 cable until after the catheter is connected and pre-
ARTMT100097718 C (2014-05)
FlexAbility
(uni-directional)
(bi-directional)
™
Ablation Catheter
Curve Configuration
D
F
J
D-D
F-F
J-J
D-F
F-J
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