English
4 M-5276-658A
T
HERMO
C
OOL
®
SF 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 T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip
Catheter is a steerable 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 dome electrode for ablation
purposes. The catheter shaft measures 7.5 F with 7.5 F ring electrodes. The
catheter is introduced through a guiding sheath with a minimum size of 8 F. 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 braided deflectable tip section
containing an array of ring electrodes. All ring electrodes are manufactured
from noble metals. The four most distal electrodes may be used for recording
and stimulation purposes. The tip dome electrode serves to deliver RF current
from the RF generator to the desired ablation site. The catheter incorporates a
temperature sensor that is embedded in the 3.5mm tip dome electrode. A
Rocker Lever is used to deflect the tip. The high-torque shaft 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 T
HERMO
C
OOL
®
SF
Diagnostic/Ablation Deflectable Tip Catheters
include BB, DD, FF, JJ, BD, FJ,
DJ, BF, and DF.
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 dome electrode. During ablation,
heparinized normal saline is passed through the internal lumen of the catheter
and through the multi-holed, irrigated, tip dome electrode. The saline irrigates
and cools the ablation site as well as the electrode tip. A compatible irrigation
pump is used to control the saline irrigation.
The catheter does not have a location sensor embedded in the tip section, and
therefore, cannot be used with the C
ARTO
®
EP Navigation System. It is,
however, otherwise similar to the T
HERMO
C
OOL
®
SF Nav
Diagnostic/Ablation
Deflectable Tip Catheter. The catheter interfaces with standard recording
equipment and a compatible RF generator via accessory extension cables with
the appropriate connectors.
For further description of the operation of the irrigation pump and the RF
generator, refer to the operating instructions for these instruments.
Indications and Use
The Biosense Webster T
HERMO
C
OOL
®
SF
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.
Contraindications
Do not use this catheter:
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 safety of discontinuing anticoagulation therapy following catheter
ablation of atrial fibrillation has not been established; anticoagulation
therapy in such patients should be administered in accordance with the
ACC/AHA/ESC 2006 Guidelines for the Management of Patients in Atrial
Fibrillation (Fuster V, Ryden LE, Cannom DS et al. ACC/AHA/ESC 2006
Guidelines for the management of the patients with atrial fibrillation
Circulation 2006: 114:257-354).
7. The safety and effectiveness of radiofrequency ablation for the treatment of
atrial fibrillation in patients with significant left ventricular dysfunction,
advanced heart failure, substantial left atrial enlargement, and structural
heart disease have not been established.
8. The catheter has not been shown to be safe at electrode temperatures
above 40º C.
9. 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
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