Medtronic Cardioblate CryoFlex Mode D'emploi page 3

Potential Adverse Events or
Complications
Potential adverse events with this device are
similar to other cardiac surgery procedures and
may include the following: bleeding; re-operation;
extension of extracorporeal bypass; heart rhythm
disturbances (atrial and/or ventricular); pericardial
effusion; pericarditis; cardiac tamponade; pleural
effusion; mediastinitis; conduction disturbances
(SA/AV node); acute ischemic myocardial event;
thrombus formation; low cardiac output; stroke;
renal, gastrointestinal or respiratory complications;
sepsis; adjacent structural damage; and death.
• Avoid contact between the cryoablation probe
and the phrenic nerve to avoid injury.
• Cryoablation involving coronary vessels has been
associated with subsequent clinically significant
arterial stenosis. It is unknown whether
cryoablation with the Cardioblate
Surgical Ablation Probe will have such an effect,
but as in all such procedures, care should be
taken to minimize unnecessary contact with
coronary vessels during cryoablation.
Warnings
• Do not insert the probe inside a beating heart. If
a breach occurs in the probe inside a beating
heart, this may result in severe injury or death to
the patient.
• Do not pull on the probe, clamp or console while
its ablation segment is frozen to tissue as this
could lead to inadvertent tissue damage.
• Do not use excessive application force when
using the probe in order to avoid tissue damage.
• Surgical probe and clamp procedures may
mechanically induce arrhythmias.
• The probe should be positioned correctly and the
placement of the ablation segment confirmed
prior to cryoablation. Ensure that tissue adjacent
to the probe or below the targeted zone which is
not intended to be ablated is protected from
freezing. This avoids inadvertent lesion creation.
• The probe contains pressurized refrigerant during
operation. Discontinue treatment immediately if a
breach in the probe is suspected, as this may
result in release of pressurized gas and injury to
the patient or the user.
• If an unanticipated event occurs, the injection of
refrigerant can be stopped at any time by
pushing the Stop Freeze button on the control
panel.
• If you are unable to stop the injection,
immediately turn the system off by using the
ML_3967-000_RevA.indd 3
power switch located on the side of the
control panel or by disconnecting the power cord.
• Do not attempt to disconnect the probe during
operation in the freeze mode as the sudden
release of pressure may cause the probe to
recoil, which may injure the operator. The system
must be vented prior to disconnecting the probe.
• If the injection of refrigerant spontaneously stops
before the preset time on the control panel has
elapsed, replace the probe.
Precautions
•
Only appropriately trained personnel in a fully
equipped facility should perform cardiac
cryoablation procedures.
• This device was designed for single patient use
only. Do not reuse, reprocess, or resterilize this
product. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the
CryoFlex™
®
device and/or create a risk of contamination of
the device which could result in patient injury,
illness, or death.
• Discard all used probes and clamps in
accordance with hospital procedures.
• Prior to removing the probe and clamp from their
packaging, inspect the packaging to verify the
integrity of the seal. Use sterile techniques when
handling the product.
• Ensure that equipment used with the
Cardioblate
System is electrically safe and does not expose
the patient to hazards.
• Ensure that all pressure and regulator lines are
securely connected.
• Always turn off the main gas cylinder valve prior
to venting the inlet pressure line to ensure that
excess pressure is safely vented.
• Prior to using the clamp and probe on the patient,
test the clamping mechanism to ensure that it is
operational.
• Perform a test injection before placing the probe
on tissue to be ablated.
•
Do not use probes or clamps that are damaged
in any way.
• If using the clamp in a procedure, it is highly
recommended that you do not disassemble the
probe from the clamp until AFTER you have
finished using the clamp. It is difficult to
reassemble and has not been tested for such an
application.
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CryoFlex™ Surgical Ablation
®
1/4/12 10:46 PM