Directions For Use - Guerbet Sequre 2.4 Fr Notice D'utilisation

Warnings
• Always flush the lumen of the guiding catheter and the microcatheter
continuously with sterile heparinized saline solution prior to insertion.
Residual contrast media or blood clots on the microcatheter surface reduce
its lubricity, preventing smooth microcatheter movement. If flushing fails to
restore surface lubricity, suspend the use of the microcatheter and remove
it slowly and carefully, together with the guiding catheter.
• Do not pull the microcatheter with excessive force. Pulling the
microcatheter with excessive force may cause serious mechanical damage,
which may necessitate retrieval.
• Do not use excessive force when navigating the microcatheter or when
advancing the guide wire through a kinked or blocked microcatheter. This
may result in mechanical damage to the microcatheter and may cause
damage to the blood vessels.
• Do not forcefully advance the microcatheter in extremely tortuous
vasculature. This may result in kinks in the microcatheter or damage to the
blood vessels.
• Manipulating the microcatheter and/or the guide wire against resistance
may result in damage to the blood vessel, the microcatheter or the guide
Precautions
• US Federal law restricts this device to sale by or on the order of a physician.
• The microcatheter must only be used by physicians who are thoroughly
trained in the intended procedures.
• The entire procedure must be carried out in a sterile environment.
• Before opening, verify that the sterile packaging has not been
compromised or damaged in any way.
• Before opening, ensure that the use-by date, printed on the label, has
not expired.
• Before starting the procedure, the microcatheter itself must be visually
inspected for any kinks, bends or other mechanical irregularities.
• Before use, the surface of the microcatheter must be completely wet with
sterile heparinized saline solution to activate the hydrophilic coating.
• Manipulation of the microcatheter must be constantly monitored through
a high-resolution fluoroscope and/or a digital subtraction angiography
monitor.
Precautions for storage
• Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.

Directions for use

1. Carefully remove the microcatheter in its hoop holder from the sterile
pouch.
2. Flush the holder with sterile heparinized saline solution through the
attached hub on the holder using a syringe, or immerse the microcatheter
in its holder in a sterile heparinized saline solution bath to thoroughly wet
the surface of the microcatheter.
CAUTION: The heparinized saline solution should be injected slowly so that
the microcatheter is not driven out of the holder.
3. Slowly remove the microcatheter from its holder.
If any resistance is felt, do not use force. Inject sterile heparinized saline
solution into the holder again and try to remove gently once more.
CAUTION: Do not use if the microcatheter has been damaged or if any other
abnormality is observed. Hold the microcatheter by its hub during handling.
4. Use a syringe to prime the microcatheter lumen with sterile heparinized
saline solution through its hub. To reduce the injection resistance, the use
of a 1 ml or 2.5 ml luer lock syringes is recommended. Slowly inject 2-3 ml
into the microcatheter until more than 10 drops of the solution appear out
of its tip. Priming is completed if no air bubbles can be seen in these drops.
5. Attach a hemostatic valve or rotating hemostatic valve (Tuohy-Borst type)
to the hub of the microcatheter, if necessary. Insert a guide wire, previously
immersed in sterile heparinized saline solution and of a compatible size
into the microcatheter through its hub or the attached valve and advance
the guide wire to the distal end of the microcatheter. A torque device may
be attached to the proximal end of the guide wire to facilitate guide wire
manipulation. To maintain surface lubricity, immerse the microcatheter
and guide wire assembly in a sterile heparinized saline solution bath or put
it back into the microcatheter holder filled with sterile heparinized saline
solution.
wire. If the situation is not able to be resolved, withdraw the entire system
of the microcatheter with the guiding catheter. During the procedure,
continuously monitor the manipulation and location of the microcatheter in
the vessel by confirming the position of the microcatheter tip through a high-
resolution fluoroscope and/or a digital subtraction angiography monitor. If
any resistance is felt, do not advance or withdraw the microcatheter until
the cause of resistance is determined through a high-resolution fluoroscope
and/or a digital subtraction angiography monitor.
• Do not soak or wipe the microcatheter with agents containing organic
solvents, like antiseptic alcohol. It may damage the microcatheter or it may
decrease the lubricity of the microcatheter.
• The infusion pressure in this microcatheter must never exceed 8270 kPa
(1200 psi). A pressure that is higher than this maximum may cause serious
mechanical failure in the microcatheter.
• The appropriate antiplatelet/anticoagulation therapy should be
administered pre- and post-procedure in accordance with standard medical
practice.
• Refer to instructions for use information on any drugs and/or devices you
may wish to use with this microcatheter to determine compatibility and to
prevent microcatheter damage.
• Before starting a procedure, ensure that all devices and tools are in
acceptable working condition.
• Choose the microcatheter size that is most suitable from a diagnostic and
anatomical point of view.
• This device is sterilized with ethylene oxide gas (EtO) and is intended for
single use only. Do not re-sterilize and/or reuse this device, as this might
lead to patient infection or injury.
• Do not use if the unit package or the product has been damaged or soiled.
• Use immediately after opening the package and dispose of safely
following your local procedure for the disposable of medical waste.
CAUTION: Do not insert the guide wire through the microcatheter's distal
end. This may damage the microcatheter. When applicable, prime the
hemostatic valve first, before inserting the guide wire into the microcatheter
and advancing it to the distal end of the microcatheter.
6. Insert a guiding catheter into the patient's blood vessel. Attach a rotating
hemostatic valve (Tuohy-Borst type) to the guiding catheter and irrigate
the catheter continuously with heparinized saline solution. Antiplatelet/
anticoagulation therapy should be administered in accordance with
standard medical practice.
Insert the microcatheter and the guide wire assembly through the valve
into the guiding catheter and advance to the distal end of the guiding
catheter. For smooth insertion through the rotating hemostatic valve and
guiding catheter, it is recommended to keep the guide wire tip within the
microcatheter until the microcatheter reaches the distal end of the guiding
catheter.
WARNING: Do not manipulate and/or withdraw the microcatheter through
a metal entry needle or a metal dilator. Manipulation and/or withdrawal
through a metal entry needle or a metal dilator may result in abrasion of the
surface coating, destruction and/or separation of the microcatheter shaft.
If the guiding catheter is fitted with a stopcock, do not close the stopcock
with the microcatheter inside the guiding catheter. The microcatheter may
be broken. Make sure that the guiding catheter does not slip out of the
blood vessel. If the guiding catheter is dislocated from the vessel while the
microcatheter and/or the guide wire are being advanced, this may result in
damage to the microcatheter.
CAUTION: Do not excessively tighten the rotating hemostatic valve on the
microcatheter, or manipulate the microcatheter through a tightened valve.
Damage to the microcatheter may occur. If resistance is felt, do not force the
microcatheter into the guiding catheter as this may result in the damage of
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