Contraindications - Johnson & Johnson Biosense Webster ThermoCool SF Mode D'emploi

Cathéter de diagnostic et d'ablation à extrémité orientable

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SF Diagnostic/Ablation Deflectable Tip Catheter

HERMO

OOL

STERILE. Sterilized with ethylene oxide gas.



For single use only.



Do not resterilize.

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Do not use if the package is open or damaged.

Device Description

The Biosense Webster T

HERMO

OOL

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. 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. All ring electrodes are manufactured from noble metals and 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 3.5 mm tip dome electrode. Additionally, a variety of curve types are available.

Attributes for the various versions of the catheters are contained in Table 1.

*The two proximal-most electrodes (electrodes 5 and 6) on the catheter cannot be used for stimulation and recording purposes.

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

Biosense Webster T

SF NAV Diagnostic/Ablation Deflectable Tip Catheter. The catheter interfaces with standard recording equipment and a compatible RF generator via accessory extension

HERMO

OOL

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

OOL

and, when used in conjunction with a radiofrequency generator, for cardiac ablation.

Contraindications

Do not use this catheter:

If the patient has had a ventriculotomy or atriotomy within the preceding eight weeks because the recent surgery may increase the risk of perforation.

In the patient with a myxoma or an intracardiac thrombus as the catheter could precipitate an embolus.

In patients with prosthetic valves as the catheter may damage the prosthesis.

In the coronary vasculature due to risk of damage to the coronary arteries.

In patients with an active systemic infection because this may increase the risk of cardiac infection.

Via the transseptal approach in a patient with an interatrial baffle or patch because the opening could persist and produce an iatrogenic atrial shunt.

Via the retrograde trans-aortic approach in patients who have had aortic valve replacement.

Warnings and Precautions

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.

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.

This catheter may damage the prosthetic tricuspid valve of a patient if the catheter is accidentally advanced through the valve.

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.

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.

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 with Atrial Fibrillation (Fuster V, Ryden LE, Cannom DS et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with

atrial fibrillation. Circulation 2006: 114:257-354).

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.

The catheter has not been shown to be safe at electrode temperatures above 40 °C.

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.

10. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Patients who experience inadvertent complete AV block

as a result of RF ablation may also require permanent pacing.

11. During the trans-aortic approach, adequate fluoroscopic visualization is necessary to avoid placement of the catheter in the coronary vasculature. Intracoronary placement of the ablation catheter, RF energy

application, or both have been associated with myocardial infarction.

12. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers.

13. To minimize risk of atrio-esophageal fistula, precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the esophagus.

14. Minimize X-ray exposure during the procedure. Catheter ablation 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. 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. Careful consideration must therefore be given for the use of

the device in pregnant women.

15. Do not expose catheter to organic solvents such as alcohol.

16. Do not autoclave the catheter.

17. Do not immerse proximal handle or cable connector in fluids; electrical performance could be affected.

18. Do not scrub or twist the distal tip electrode during cleaning.

19. Inspect irrigation saline for air bubbles prior to its use in the procedure. Air bubbles in the irrigation saline may cause emboli.

20. Purge catheter and irrigation tubing with heparinized normal saline.

WARNING: This is a controlled proprietary and confidential document.

SF Diagnostic/Ablation Deflectable Tip Catheter is a steerable multi-electrode, luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of

SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording)

Table 1: Catheter Attributes

Catheter Attribute

Total Number of

Electrodes

Type of Connector

10-pin

Deflection

Thumb Knob

Mechanism

Curve Types

B, D, F, J

EP Navigation System. It is, however, otherwise similar to the