English
4 M-5276-559C
EZ S
TEER
®
T
HERMO
C
OOL
®
NAV Diagnostic/Ablation
Deflectable Tip Catheter
•
STERILE Sterilized with ethylene oxide gas.
•
For single use only.
•
Do not resterilize.
•
Do not use if the package is open or damaged.
Device Description
The Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV
Diagnostic/Ablation
Deflectable Tip Catheter is a 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 ablation purposes.
The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the
catheter is used in conjunction with an RF generator and a dispersive pad
(indifferent electrode).
The catheter has a high-torque shaft with a bi-directional deflectable tip section
containing an array of platinum electrodes, which includes a 3.5 mm tip dome. All
of the electrodes may be used for recording and stimulation purposes. The tip
electrode serves to deliver RF current from the RF generator to the desired
ablation site. The tip electrode and ring electrodes are made from platinum-
iridium. The catheter incorporates a thermocouple temperature sensor that is
embedded in the 3.5mm tip electrode. A Rocker Lever is used to deflect the tip.
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. Additionally, a
variety of curve types are available in symmetric or asymmetric combinations,
providing two 180° opposed, single planed curves. Currently, the available
curves for the EZ S
TEER
®
T
HERMO
C
OOL
®
NAV
Diagnostic/Ablation Deflectable
Tip Catheters include DD, FF, JJ, JF and FD.
At the proximal end of the catheter, a saline input port with a standard luer fitting
terminates from the open lumen. This saline port serves to permit the injection of
normal saline to irrigate the tip electrode. During ablation, heparinized normal
saline is passed through the internal lumen of the catheter and through the tip
electrode, to irrigate and cool the ablation site as well as the electrode tip. An
irrigation pump should be used to control the saline irrigation. The catheter
interfaces with standard recording equipment and a compatible RF generator via
accessory extension cables with the appropriate connectors.
This catheter features a location sensor embedded in the tip section that
transmits location information to the C
ARTO
®
EP Navigation System. An
appropriate reference device is required for location reference position purposes.
For use in mapping procedures, for information on appropriate reference
devices, and for further description of the operation of the C
ARTO
®
EP Navigation
System, refer to the User Manual for your C
ARTO
®
EP Navigation System.
Indications and Use
The Biosense Webster EZ S
TEER
®
T
HERMO
C
OOL
®
NAV
Diagnostic/Ablation
Deflectable Tip Catheter and related accessories are indicated for catheter-
based cardiac electrophysiological mapping (stimulating and recording) and,
when used in conjunction with a radiofrequency generator, for cardiac ablation.
The EZ S
TEER
®
T
HERMO
C
OOL
®
NAV
Diagnostic/Ablation Deflectable Tip
Catheter provides location information when used with the C
ARTO
®
EP
Navigation System.
Contraindications
Do not use this device:
1. If the patient has had a ventriculotomy or atriotomy within the preceding
eight weeks because the recent surgery may increase the risk of perforation.
2. In the patient with a myxoma or an intracardiac thrombus as the catheter
could precipitate an embolus.
3. In patients with prosthetic valves as the catheter may damage the
prosthesis.
4. In the coronary vasculature due to risk of damage to the coronary arteries.
5. In patients with an active systemic infection because this may increase the
risk of cardiac infection.
6. Via the transseptal approach in a patient with an interatrial baffle or patch
because the opening could persist and produce an iatrogenic atrial shun.
7. Via the retrograde trans-aortic approach in patients who have had aortic
valve replacement.
Warnings and precautions
1. Do not use the temperature sensor to monitor tissue temperature. The
temperature sensor located within the tip section of the catheter does 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 RF 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 RF
current, a decrease in electrode temperature confirms the onset of saline
irrigation of the ablation electrode. Monitoring the temperature from the
electrode during the application of RF current ensures that the irrigation flow
rate is being maintained.
2. It is important to carefully follow the power titration procedure as specified in
the instructions for use. Too rapid an increase in power during ablation may
lead to perforation caused by steam pop.
3. This catheter may damage the prosthetic tricuspid valve of a patient if the
catheter is accidentally advanced through the valve.
4. The patient who has had a prior atrial flutter ablation procedure may be at
greater risk for perforation and/or pericardial effusion with the use of this
catheter system.
5. In accordance with your hospital’s protocol, monitor the patient’s fluid
balance throughout the procedure to avoid fluid volume overload. Some
patients may have factors that reduce their ability to handle the volume
overload, making them susceptible to developing pulmonary edema or heart
failure during or after the procedure. Patients with congestive heart failure or
renal insufficiency, and the elderly are particularly susceptible. Prior to the
procedure, always identify the patient's risk of volume overload.
6. The catheter has not been shown to be safe at electrode temperatures
above 50º C.
7. Implantable pacemakers and implantable cardioverter/defibrillator (ICDs)
may be adversely affected by RF current. It is important to have temporary
external sources of pacing and defibrillation available during ablation and to
temporarily reprogram the pacing system to minimum output or OFF mode
to minimize the 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; and,
perform complete implantable device analysis on all patients after ablation.
8. Patients undergoing septal accessory pathway ablation are at risk for
complete AV block which requires the implantation of a permanent
WARNING: This is a controlled proprietary and confidential document.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
