Adverse Reactions - Johnson & Johnson Biosense Webster ThermoCool SF Mode D'emploi

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The catheter tip can be deflected to facilitate positioning by using the thumbknob to vary tip curvature. Tip deflection is controlled at the proximal end of the catheter 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.
12. For RF application and flow settings refer to Table 2.
13. Recommendation for irrigation: Increase the irrigation to high flow rate starting up to 5 seconds before the onset of RF energy delivery and maintaining this higher flow rate up to 5 seconds after termination
of the energy application. For power levels up to 30 W, a high flow rate of 8 ml/min should be used. For power levels between 31-50 W, a high flow rate of 15 ml/min should be used. Do not use the
catheter without irrigation flow.
14. Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation. If the temperature increases to 40 °C during RF energy delivery, power delivery should be interrupted. The
irrigation system must be rechecked prior to restarting RF delivery. Note: the displayed temperature represents the temperature of the electrode only, not the temperature of the tissue.
15. Start a procedure at 15-20 W. After 15 seconds, power may be increased by 5-10 W increments as needed, until a transmural lesion is achieved, defined by > 80% reduction in unipolar atrial electrogram
amplitude, or emergence of double potentials of equal and low amplitude. It is recommended that power not exceed 50 W when the catheter is parallel to the tissue and 35 W if the catheter is perpendicular
to the tissue. The duration of each RF ablation should not exceed 120 seconds. Dragging the catheter to the next location is permissible during the 120-second energy application. RF current may be
reapplied to the same or alternate sites using the same catheter.
16. In the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip dome electrode inspected for coagulum before RF current is reapplied. To remove any coagulum,
if present, a sterile gauze pad dampened with sterile saline may be used to gently wipe the tip section clean; do not scrub or twist the tip dome electrode as damage to the tip dome electrode bond may
occur and loosen the tip dome electrode. Prior to reinsertion, ensure that the irrigation holes are not plugged as follows:
a. Fill a 1 or 2 ml syringe* with sterile saline and attach to the stopcock on the end of the irrigation tubing.
b. Carefully inject the saline from the syringe into the catheter. Uniform streams of fluid should be visible from the tip of the catheter.
c. Repeat steps a and b, if necessary.
d. Flush catheter and tubing per standard technique to ensure purging of trapped air bubbles and to verify that the irrigation holes are patent.
e. The catheter can now be introduced into the patient.
WARNING: Do not continue use of the catheter if still occluded or if it is not functioning properly.
*NOTE: A small syringe provides sufficient pressure to produce a visible stream of fluid.

Adverse Reactions

A number of serious adverse reactions have been documented for catheter ablation procedures including pulmonary embolism, myocardial infarction, stroke, cardiac tamponade, and death.
The following complications were also noted to have occurred during prior studies or have been reported in the literature:
1. Catheterization/catheter procedure related: vascular bleeding/local hematomas, thrombosis, AV fistula, pseudoaneurysm, thromboembolism and vasovagal reactions, cardiac perforation, pericardial
effusion/tamponade, thrombi, air embolism, arrhythmias and valvular damage, pneumothorax and hemothorax, pulmonary edema, hypoxia, pleural effusion, acute respiratory distress syndrome (ARDS),
congestive heart failure, aspiration pneumonia, pneumonia, asthmatic attack, hypotension, ICD lead malfunction, anemia, thrombocytopenia, disseminated intravascular coagulation, epistaxis, systemic
infection, urinary tract infection, sedation induced apnea, sedation induced CO
2. RF related: chest pain/discomfort, ventricular tachyarrhythmia, TIA, CVA, complete heart block, coronary artery spasm, coronary artery thrombosis, coronary artery dissection, cardiac thromboembolism,
pericarditis, cardiac perforation/tamponade, valvular damage and increased phosphokinase level.
3. Unrelated to device or procedure: urinary retention, transient extremity numbness, Parkinson's disease and gastrointestinal diverticulosis.
DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE
PRODUCT(S) DESCRIBED HEREIN. UNDER NO CIRCUMSTANCES SHALL BIOSENSE WEBSTER, INC., OR ITS AFFILIATED COMPANIES, BE LIABLE FOR ANY SPECIAL, DIRECT, INCIDENTAL,
CONSEQUENTIAL, OR OTHER DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW.
WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS AFFILIATED COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL, DIRECT, INCIDENTAL, CONSEQUENTIAL, OR
OTHER DAMAGES, ARISING OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW.
Descriptions and specifications appearing in Biosense Webster, Inc. printed matter, including this publication, are informational only and meant solely to generally describe the product at the time of manufacture
and are not made or given as a warranty of the prescribed product in any way.
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WARNING: This is a controlled proprietary and confidential document.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
Table 2: RF and Flow Settings
RECOMMENDED RF APPLICATION PARAMETERS
ATRIAL
ABLATION
Power Range 15 W to 30 W*
Temperature Monitoring ≤ 40 °C**
Irrigation Flow Rate During 8 ml/min
RF Application
Application Time 30 to 120 seconds
* Power levels exceeding 30 W may be used when transmural lesions
cannot be achieved at lower energy levels. For power settings > 30 W,
the recommended irrigation flow rate is 15 ml/min.
** The temperature displayed on the RF generator does not represent tissue
temperature or electrode tissue interface temperature.
Additional Recommendation:
For isthmus dependent flutter ablation, power applications exceeding 30 W
and up to 50 W should only be used if conduction block cannot be achieved
at lower power levels.
retention with lethargy and cholecystitis.
2
VENTRICULAR
ABLATION
31 W to 50 W
≤ 40 °C**
15 ml/min
60 to 120 seconds
M-5276-688A
Release Date: 3/7/2011