English
PR-000 985_J
3/43
Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
CAUTION
••••
Sterile. Sterilized with ethylene oxide gas.
••••
For single use only.
••••
Do not use if the package is open or damaged.
••••
Do not attempt to operate the device prior to completely reading
and understanding the applicable instructions for use.
1
CATHETER DESCRIPTION
The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
designed for cardiology application is an 8.5 F introducer compatible
multi-electrode luminal catheter with a deflectable tip designed to facilitate
electrophysiological mapping of the heart and to transmit radiofrequency
(RF) current to the catheter tip electrode for intracardial ablation purposes.
For ablation the catheter is used in conjunction with a radiofrequency
generator and a dispersive pad (indifferent patch electrode).
The catheter has a high-torque shaft with a deflectable tip section with
four platinum-iridium electrodes. All of the electrodes may be used for
recording and stimulation purposes. The tip electrode is used to deliver
radiofrequency current from the radiofrequency generator to the desired
ablation site. The tip electrode and ring electrodes are made of platinum-
iridium. The catheter incorporates a thermocouple temperature sensor
which is embedded in the 3.5 mm tip electrode. Tip deflection is controlled
at the proximal end by a handpiece in which a piston slides; a thumbknob
on the piston controls piston travel. When the thumbknob is pushed
forward the tip is deflected (curved). When the thumbknob is pulled back
the tip straightens. The shape of the curve depends on the deflectable tip
length (currently available: 65 mm). The high-torque shaft also allows the
plane of the curved tip to be rotated to facilitate accurate positioning of the
catheter tip at the desired site.
At the proximal end of the catheter lead-out a saline port with a standard
Luer fitting terminates from the open lumen. This saline port is used to
permit the delivery of isotonic saline solution to irrigate the tip electrode.
During ablation normal saline is passed through the 0.7 mm diameter
lumen of the catheter and through the tip electrode, to irrigate and cool
both the catheter tip and the ablation site.
The catheter interfaces with standard recording equipment and a
compatible radiofrequency generator via accessory Endosense Splitter
with the appropriate connectors.
The distal force sensing technology called Touch+
®
is also an integral part
of Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter.
For use in conjunction with force sensing refer to the TactiCath
®
System
User Manual.
2
INDICATIONS
The Endosense TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter
is indicated for use in cardiac electrophysiological mapping (stimulation
and recording) and, when used in conjunction with a radiofrequency
generator, for cardiac ablation in the right atrium (RA) and in the left
atrium (LA), such as:
••••
Interruption of accessory atrioventricular (AV) conduction
pathways associated with tachycardia, called the Wolff-
Parkinson-White syndrome (WPW);
••••
Treatment of AV nodal re-entrant tachycardia (AVNRT);
••••
Creation of complete AV nodal block in patients with a difficult to
control ventricular response to an atrial arrhythmia;
••••
Creation of a RA isthmus line for patients with isthmus
dependent atrial flutter;
••••
Atrial fibrillation.
3
CONTRAINDICATIONS
••••
The catheter must not be used for radiofrequency ablation if the patient
has intracardiac mural thrombus or has had a ventriculotomy or
atriotomy within the preceding four weeks.
••••
The catheter may not be appropriate for patients with prosthetic valves
and must not be used in the coronary vasculature.
••••
A relative contraindication for catheter ablation procedures is active
systemic infection.
••••
The transseptal approach is contraindicated in patients with left atrial
thrombus or myxoma, or interatrial baffle or patch.
4
WARNINGS
a)
The temperature sensor located within the electrode will not reflect
either electrode tissue interface or tissue temperature due to the
cooling effects of the saline irrigation of the electrode. The
temperature displayed on the generator is the temperature of the
cooled electrode, not tissue temperature. The temperature sensor is
used to verify that the irrigation flow rate is adequate. Before
initiating the application of radiofrequency current, a decrease in
electrode temperature confirms the onset of saline irrigation of the
ablation electrode. Recording temperature from the electrode during
the application of radiofrequency current ensures that the irrigation
flow rate is being maintained.
b)
Patients undergoing septal accessory pathway ablation are at risk for
complete AV block which requires the implantation of a permanent
pacemaker. Permanent pacing may be required in patients who
experience inadvertent complete AV block as a result of
radiofrequency ablation.
c)
Implantable pacemakers and implantable cardioverter/defibrillator
(ICDs) may be adversely affected by radiofrequency current. It is
important to:
••••
Have temporary external sources of pacing and
defibrillation available during ablation.
••••
Temporarily reprogram the pacing system to minimum
output to minimize risk of inappropriate pacing.
••••
Exercise extreme caution during ablation when in close
proximity to atrial or ventricular permanent leads.
••••
Program the ICD to the OFF mode during the ablation
procedure.
••••
Perform complete implantable device analysis on all
patients after ablation.
d)
The combination of intracoronary placement of the ablation catheter
and radiofrequency energy application has been associated with
myocardial infarction.
e)
Significant x-ray exposure can result in acute radiation injury as well
as increased risk for somatic and genetic effects, to both patients
and laboratory staff. Therefore catheter ablation should only be
performed after adequate attention has been given to the potential
radiation exposure associated with the procedure, and steps taken to
minimize this exposure. Careful consideration must therefore be
given for the use of the device in pregnant women.
f)
Do not expose catheter to organic solvents such as alcohol.
g)
Do not resterilize/reuse the catheter.
h)
Do not immerse proximal handle or cable connector in fluids;
electrical performance could be affected.
i)
Do not scrub or twist the distal tip electrode during cleaning.
j)
Inspect saline irrigation for air bubbles prior to its use in the
procedure. Air bubbles in the saline irrigation may cause emboli.
5
PRECAUTIONS
a)
Do
not
attempt
to
operate
the
Endosense
TactiCath
®
Diagnostic/Ablation Deflectable Tip Catheter or the radiofrequency
generator prior to completely reading and understanding the
applicable instructions for use.
b)
Cardiac ablation procedures must be performed by appropriately
trained personnel in a fully-equipped electrophysiology laboratory.
c)
The long-term risks of protracted fluoroscopy and creation of
radiofrequency induced lesions have not been established. Careful
consideration must therefore be given for the use of the device in
prepubescent children. Furthermore, the risk/benefit in asymptomatic
patients has not been studied.
Summary of Contents for TactiCath
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