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

heparin/ml) normal saline bag using standard safe hospital practices. To
complete the electrical circuit, connect an indifferent electrode to the
indifferent electrode input on the generator.
6. Flush the catheter and tubing per standard technique to ensure purging of
trapped air bubbles and to verify that the irrigation holes are patent.
7. Start continuous irrigation at a flow rate of 2 ml/min.
8. Insert the Biosense Webster T
Diagnostic/Ablation Catheter via the entrance site using the insertion tube
and an appropriately sized introducer sheath. Advance the catheter to the
area under investigation.
9. Use both fluoroscopy and electrograms (EGM) to aid in proper positioning.
10. In order to achieve optimal force reading accuracy and stability, allow the
catheter to warm up for 15 minutes after connection to the C
System, and 5 minutes after insertion into the body prior to use of the force
feedback feature.
11. Zero the contact force reading following insertion into the patient. The tip
electrode and first two ring electrodes must be outside of the sheath so that
the force sensor is inside the body. Ensure the catheter tip is not in contact
with tissue by evaluating the location on fluoroscopy and the C
System, the EGM amplitude, and catheter movement. Variations in the
force reading at the same rate as the cardiac or respiration cycle may
indicate contact with cardiac structures. Once these markers indicate the tip
is not in contact, the reading can be zeroed. Refer to the User Manual for
®
your C
ARTO
reading.
12. Zero the contact force reading when moving the catheter from one chamber
of the heart to another or upon re-insertion.
13. The catheter tip can be deflected to facilitate positioning by using the
thumbknob to vary tip curvature. Pushing the thumbknob forward causes
the catheter tip to deflect; when the thumbknob is pulled back, the tip
straightens.
14. For RF application and flow settings refer to Table 1.
RECOMMENDED RF APPLICATION PARAMETERS
Power Range
Temperature Monitoring
Irrigation Flow Rate During
RF Application
Application Time
* 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 30 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.
15. 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 until 5 seconds after termination of the
energy application. For power levels up to 30 W, a high flow rate of
17 ml/min should be used. For power levels between 31-50 W, a high flow
rate of 30 ml/min should be used.
16. The application of RF energy must not be initiated until the increase in
irrigation flow rate is confirmed by a minimum of 2° C decrease in tip
electrode temperature.
17. Monitor the catheter tip temperature throughout the procedure to ensure
adequate irrigation. The peak temperature should not exceed 50° C during
RF energy delivery. Note: the displayed temperature represents the
temperature of the electrode only, not the temperature of the tissue.
18. 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. 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.
19. RF current may be reapplied to the same or alternate sites using the same
catheter. However, in the event of a generator cutoff (impedance or
temperature), the catheter must be withdrawn and the tip 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
electrode as damage to the tip electrode bond may occur and loosen the tip
electrode or damage may also occur to the contact force sensor and affect
measurement accuracy. Prior to reinsertion, ensure that the irrigation holes
are not plugged by increasing the flow rate and verifying flow from each of
the six irrigation holes.
If irrigation hole occlusion occurs:
a) Fill a 1 or 2 ml syringe* with sterile saline and attach to the stopcock
or sidearm.
b) Carefully inject the saline from the syringe into the catheter. A stream
of fluid should be visible from all six (6) holes.
c) Repeat steps a and b, if necessary until the holes are cleared.
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.
f) Zero catheter following re-insertion into 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:

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
retention with lethargy and cholecystitis.

RF related: chest pain/discomfort, ventricular tachyarrhythmia, TIA, CVA,
complete heart block, coronary artery spasm, coronary artery thrombosis,
M-5276-692A
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AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
HERMO
3 System for instructions on how to zero the contact force
Table 1: RF and Flow Settings
15 W to 30 W*
30 to 120 seconds
®
C S
OOL MART
ATRIAL
ABLATION
< 50° C**
17 ml/min
English
™
T
OUCH
®
3
ARTO
®
ARTO
VENTRICULAR
ABLATION
31 W to 50 W
< 50° C**
30 ml/min
60 to 120 seconds
2
7