QXMédical, LLC
Document Part Number: 3064-001, Rev. 06 (10/2019)
Page 5 of 76
9.6
Remove the syringe from the guidewire lumen port, fill
with 15 cc of heparinized saline solution and connect it to
the stopcock. Ensure that the stopcock is OPEN and draw
vacuum.
9.7
While maintaining the balloon under vacuum, gently
remove the protective sleeve from the balloon by
twisting the sleeve in one direction and pulling it off the
balloon.
9.8
Partially inflate the balloon and draw a vacuum to remove
air from the catheter.
9.9
Air removed from the catheter and accumulated in the
syringe may be expelled by turning the stopcock OFF,
removing the syringe and ejecting the air.
9.10 Attempt to remove all the air in the balloon by repeating
steps 9.8 and 9.9 as required. Some changes in the
catheter orientation may be necessary to vent all the
air. Ensure no air is introduced to the catheter when
reconnecting the syringe to the stopcock.
9.11 Draw vacuum, turn the stopcock OFF and remove the
syringe. Set the catheter aside until needed.
NOTE:
If air bubbles continue to appear in the syringe
during catheter preparation or if liquid leakage is seen at
any point on the catheter (including the balloon bonds,
tip or manifold), please discard the catheter and use a
new one.
10. DEVICE USAGE
10.1 Using standard techniques, introduce the guidewire
through the introducer sheath, ensuring it is advanced
beyond the balloon target location.
10.2 Prior to introducing the catheter, determine the
amount of diluted contrast (75% sodium chloride / 25%
renographin) needed to inflate the balloon to the desired
diameter. Refer to the balloon inflation parameters
outlined in the Balloon Compliance Chart (Table 1).
WARNING:
Over-inflation may result in damage to vessel
wall and/or vessel rupture, or damage to the stent graft.
10.3 Place the prepared catheter over the previously inserted
guidewire by threading the end of the guidewire through
the tip of the catheter.
10.4 Verify that the balloon is completely deflated and slowly
advance through the introducer sheath.
10.5 Using fluoroscopic imaging, carefully advance the
catheter to the desired location in the vasculature or stent
graft using the markerbands (distal & proximal end of the
balloon) for visual guidance. When using the Stent Graft
Balloon Catheter to expand a vascular prosthesis, use the
radiopaque markers to ensure that the entire balloon is
positioned within the prosthesis.
CAUTION:
When aligning the position of the catheter
so that the balloon is in proper position for expansion
within vessel or stent graft, pay careful attention to the
fluoroscope location in order to avoid parallax or other
sources of visualization error.
10.6 When the Stent Graft Balloon Catheter is positioned
properly, it may be appropriate to decrease the patient’s
blood pressure to approximately 80 mm Hg to facilitate
ballooning.
CAUTION:
Failure to lower the blood pressure during
thoracic cases may cause balloon movement and may
result in graft misplacement.
10.7 Fill the 60 cc syringe with the desired amount of diluted
contrast solution and attach it to the stopcock ensuring
that no air is introduced to the balloon catheter. Open the
stopcock and inflate the balloon at the target location.
Continuously monitor fluoroscope screen, watching
for stent movement. Proper modeling should show
very slight outward expansion of stent with balloon
inflation. Be careful not to over inflate – stop right after
stent expansion is evident. Table 1 below is a guideline
for determining the volume of diluted contrast solution
required to obtain a given balloon expansion diameter.
Table 1: Balloon Compliance Chart
Recommended Inflation
Volume
Balloon Diameter
3 cc
10 mm
6 cc
20 mm
16 cc
30 mm
32 cc
40 mm
44 cc
45 mm
60 cc
50 mm*
* Maximum Inflation Diameter -- DO NOT EXCEED
50 mm Balloon Diameter and DO NOT EXCEED 60
cc inflation at 50 mm balloon diameter.
CAUTION:
The above chart is only a guide. Balloon
expansion should be carefully monitored with the use of
fluoroscopy.
NOTE:
The balloon has been tested to temporarily
occlude vessels up to 41 mm in diameter.
10.8 Fully deflate balloon and verify using fluoroscopy that the
balloon is deflated. Move the balloon; inflate and deflate
the balloon to smooth wrinkles in the graft material and
to enhance contact between the stent graft and the
vessel wall.
10.9 If necessary, repeat until all target areas of the stent graft
have been balloon-modeled. Inflate the balloon with
sufficient pressure to firmly embed the stent graft against
the vessel.
CAUTION:
Balloon is highly compliant. Inflate slowly. Do
not over-inflate balloon when modeling graft in vessels.
Operator should visualize the stent graft at all times
during balloon inflation to detect any movement of the
stent graft. Use special care in areas of diseased vessels to
avoid rupture or vessel trauma.
10.10 If balloon pressure is lost and/or balloon rupture occurs,
deflate the balloon and remove balloon and sheath as a
unit.
10.11 When balloon inflations are complete, draw a vacuum in
the balloon and verify that the balloon is fully deflated.
10.12 Maintain vacuum on the balloon and withdraw the Stent
Graft Balloon Catheter back through the introducer
sheath. Use fluoroscopic imaging to ensure that the stent
graft does not move and to track the movement of the
Stent Graft Balloon Catheter throughout the withdrawal.
10.13 If resistance is met during withdrawal, apply negative
pressure with a larger syringe before proceeding. If
resistance continues, remove balloon and sheath as a
unit.
WARNING:
Do not torque or twist catheter during
insertion or withdrawal.
10.14 Close entry site with standard surgical closure technique.
11. DISPOSAL
After use, this product is a potential biohazard. Handle and dispose
of in accordance with accepted medical practice and applicable
hospital, local, state and federal laws and regulations.
WARRANTY DISCLAIMER AND LIMITATION OF LIABILITY
ALTHOUGH THE STENT GRAFT BALLOON CATHETER HAS BEEN
MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS,
QXMÉDICAL, LLC HAS NO CONTROL OVER THE CONDITIONS
UNDER WHICH THE STENT GRAFT BALLOON CATHETER IS USED.
QXMÉDICAL, LLC THEREFORE DISCLAIMS ALL WARRANTIES,
BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE STENT
GRAFT BALLOON CATHETER INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE AND ANY IMPLIED WARRANTY
ARISING FROM COURSE OF PERFORMANCE, DEALING, USAGE OR
