Guerbet Sequre, Instructions For Use Manual

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Directions for use
(cont.)
the microcatheter. Do not advance the microcatheter without a guide wire,
as kinks in the distal and proximal sections of the microcatheter may occur.
7. Continuously monitor the location of the microcatheter tip in the blood
vessel during the procedure using high-resolution fluoroscope and/or a
digital subtraction angiography monitor.
WARNING: 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.
Manipulating the microcatheter and/or the guide wire against resistance
may result in damage to the blood vessel, microcatheter or guide wire. If the
microcatheter is advanced inside the blood vessel without the guide wire, it
may result in damage to the vessel. When re-inserting the guide wire into the
microcatheter, carefully advance the guide wire while monitoring the position
of the guide wire tip through a high-resolution fluoroscope and/or a digital
subtraction angiography monitor. Any erratic movement may cause damage
to the vessel.
CAUTION: When advancing the microcatheter into the peripheral vessel,
draw it back slightly under fluoroscopy each time it has been advanced, to
ensure that the microcatheter has not been advanced so far that it cannot be
withdrawn. Do not manipulate the microcatheter by force. The microcatheter
tip is highly flexible and may be stretched or damaged.
8. When the desired site is reached, remove the guide wire from the
microcatheter.
CAUTION: Drawing back the guide wire against resistance may cause the
microcatheter to kink. If any resistance is felt, draw the microcatheter back to
a position where no guide wire resistance is felt, then remove the guide wire.
If the guide wire is withdrawn without this manipulation, the microcatheter
may be impaired. Rinse residual blood from the removed guide wire in a
sterile heparinized saline solution bath. If the residual stains will not come
off, wipe the guide wire once with a sterile gauze moistened with heparinized
saline solution. Blood remaining on the guide wire may cause resistance when
re-inserted back into the microcatheter.
9. Before introducing an embolic material or other agent, slowly
inject a small volume of contrast media into the microcatheter using
a syringe and verify under high resolution fluoroscopy and/or a digital
subtraction angiography monitor that the media is dispelled from the
distal microcatheter tip. With its small lumen, the microcatheter offers a
high resistance to infusion. When injecting contrast media or drugs with
a syringe, use a 1 ml syringe or smaller. Refer to instructions for use for
any drugs and/or devices you may wish to use with this microcatheter to
determine compatibility and prevent microcatheter damage. If different
types of embolic material or agents are being used, it is recommended to
use a new microcatheter each time. When injecting contrast media through
a S equrE® microcatheter under fluoroscopy, it may be seen exiting radially
from the slits which are located between the two radiopaque markers, in
addition to exiting through the distal tip.
Note: It is recommended to heat the contrast medium to 37 °C before use.
WARNING:
If an increase of resistance is felt when injecting fluid through the
microcatheter, replace the microcatheter with a new one. Injection against
increased resistance may cause the microcatheter to rupture, potentially
injuring the blood vessel. If no contrast media is visible flowing from the
microcatheter, it may indicate kinking of the microcatheter. If drawing back
the microcatheter fails to correct the kink, replace the microcatheter with a
new one. Do not try to correct the kink by inserting a guide wire or by power
injection. Introduction of embolic materials or agents without first correcting
the kink, or attempts to correct the kink by inserting a guide wire or by power
injection may cause the microcatheter to rupture or separate and this may
result in damage to the vessel. Friction between the microcatheter’s inner
lumen and the embolic material may cause the microcatheter to advance
forward, potentially resulting in perforation of the vessel wall. To prevent this,
draw the microcatheter back slightly and hold in place.
CAUTION: Increased resistance to infusion suggests that the microcatheter
may be blocked by the drug or contrast media being infused or with blood
clots. Immediately terminate the infusion and replace the microcatheter.
When a power injector is to be used, follow the instructions given below
under “Instruction for Using a Power Injector with the microcatheter”.
In case of using organic solvents, make sure to check its compatibility by
checking its labeling before use. Before use, ensure the compatibility of
the size of the embolic microspheres to the chosen microcatheter size.
The compatible microsphere size range is indicated on the microcatheter’s
external packaging label and in Table 2. Before use, confirm the size
compatibility of the coiled embolic material and supportive device and
the microcatheter. When introducing embolic coils or material, do not use
devices or materials exceeding the maximal dimensions detailed in Table
2. Always check the movement of the embolic material and supportive
device through a high-resolution fluoroscope and/or a digital subtraction
angiography monitor. Do not advance or withdraw the microcatheter if any
resistance is felt in the blood vessel, especially while using embolic material.
Advance or withdraw the microcatheter, only after the cause of resistance
is determined through a high-resolution fluoroscope and/or a digital
subtraction angiography monitor. Any quick and unreasonable movement
may cause the microcatheter to break/rupture/separate, which may result in
damage to the vessel.
10. Before inserting the microcatheter into additional vessels, flush the
microcatheter with sterile heparinized saline solution. If any resistance
is felt during the insertion of the guide wire, do not advance the guide
wire any farther and replace the microcatheter. If there is any difficulty in
inserting the guide wire into the microcatheter hub, the guide wire and/or
the hub can be rotated slightly to facilitate insertion.
WARNING: When re-inserting the guide wire into the microcatheter, verify
the location of the guide wire tip through a high-resolution fluoroscope and/
or digital subtraction angiography monitor. Any erratic movement of the wire
may cause mechanical damage to the microcatheter, which may result in
damage to the vessel.
11. When the procedure is completed, carefully remove the microcatheter
together with the guiding catheter.
WARNING:
If any resistance is felt, do not remove the microcatheter by
force. Withdraw the microcatheter carefully together with the guiding
catheter. Removing the microcatheter by force may result in the fracture of
the microcatheter, which may necessitate retrieval.
Instructions for Using a Power Injector with the Microcatheter
A power injector can be used to infuse a contrast media through the
microcatheter. Observe the warnings and cautions given below. The flow
rate depends upon factors such as the viscosity of the contrast media, the
type and temperature of the media, the model and setting of the power
injector and how the injector is connected to the microcatheter.
WARNING: Do not use a power injector to infuse agents other than contrast
media, as the microcatheter may become blocked. The injection pressure
must not exceed the maximum injection pressure that corresponds to
outer diameter of each microcatheter tip (see Table 3 below). Exceeding the
maximal injection pressure may cause the microcatheter to rupture.