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60cc syringes
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Diluted contrast solution (75% sodium chloride / 25%
renographin) is recommended for balloon inflation/deflation
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Additional Occlusion Balloon Catheters
It is also recommended that a freely-angled C-Arm with high
resolution fluoroscopy, high quality angiography and Digital
Subtraction Angiography (DSA) be used during the procedure.
9. DEVICE PREPARATION
9.1
Carefully inspect the package and catheter prior to use to
verify no damage occurred during shipment. Do not use
catheter if either the catheter or packaging is damaged or
compromised.
9.2
If the packaging is free of damage, carefully open the
outer pouch and introduce the inner pouch (with
catheter) to the sterile field using sterile techniques.
9.3
Open the inner pouch and carefully disengage the
catheter, manifold and extension tube assembly from
the paperboard card. Carefully inspect the catheter for
any signs of damage. If damaged, please discard and use
another catheter.
NOTE: Patient and entry site preparation should be
performed prior to device preparation. Prepare patient
in accordance with standard techniques; including
proper administration of anticoagulation and antiplatelet
medication. Using standard techniques prepare entry
site, including placement of the introducer sheath.
NOTE: Prior to initiating a Lead Extraction procedure, the
guidewire should be advanced through the introducer
sheath and across the length of the SVC. Do not attempt
to place the guidewire after a venous tear occurs.
9.4
Fill 60cc syringe with 10cc to 15cc of heparinized saline
solution.
9.5
Attach the syringe to the guidewire lumen port and flush
the guidewire lumen.
9.6
Remove the syringe from the guidewire lumen port, fill
with 15cc of heparinized saline solution and connect it to
the stopcock. Ensure that the stopcock is OPEN and draw
vacuum. Do not introduce any solution into the balloon
during the preparation.
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
Observe the syringe for a continuing stream of air bubbles
as this may indicate a catheter leak. If a leak is observed,
please discard the catheter and use a new one.
9.9
While under vacuum, turn the stopcock OFF and remove
the syringe. Set the catheter aside until needed.
10. DEVICE USAGE
10.1
Prior to introducing the catheter, fill a 60cc syringe
with diluted contrast (75% sodium chloride / 25%
renographin) needed to inflate the balloon. Reference
the balloon inflation parameters outlined in the Balloon
Compliance Chart (Table 1) for guidance.
WARNING: Over-inflation may result in damage to vessel
wall, vessel rupture, balloon rupture or introduction of
air emboli.
10.2
Place the prepared catheter over the previously inserted
guidewire by threading the end of the guidewire through
the tip of the catheter. Advance the catheter until the
guidewire exits the proximal port and position the tip of
the catheter proximal of the introducer sheath.
10.3
Verify that the balloon is completely deflated and under
vacuum.
10.4
If required, advance the balloon catheter through the
introducer sheath. Using fluoroscopic imaging, carefully
advance the catheter to the desired location in the
vasculature using the markerbands for visual guidance.
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NOTE: For a Lead Extraction procedure, advance the
catheter until the proximal marker band is located at the
junction of the SVC and right atrium.
CAUTION: When aligning the position of the catheter so
that the balloon is in proper position for expansion within
vessel, pay careful attention to the fluoroscope location
in order to avoid parallax or other sources of visualization
error.
10.5
Fill the 60cc syringe with diluted contrast solution and
attach it to the stopcock ensuring that no air is introduced
into the balloon catheter. Open the stopcock and inflate
the balloon at the target location. Continuously monitor
fluoroscope screen, watching for balloon movement.
Table 1 (below) is a guideline for determining the volume
of diluted contrast solution required to obtain a given
balloon expansion diameter. Close the stopcock once the
desired balloon inflation is achieved.
Table 1: Balloon Compliance Chart
Recommended Inflation
Volume
20 cc
25 cc
30 cc
35 cc
40 cc
45 cc
50 cc
55 cc
60 cc
* Maximum Inflation Diameter -- DO NOT EXCEED 32mm
Balloon Diameter and DO NOT EXCEED 60cc inflation at
32mm balloon diameter.
CAUTION: The above chart is only a guide. Inflate the
balloon until vessel occlusion is achieved. Balloon
expansion should be carefully monitored with the use
of fluoroscopy.
CAUTION: Balloon is highly compliant. Operator should
visualize the balloon at all times during inflation to detect
any movement. If balloon needs to be repositioned,
completely deflate the balloon prior to repositioning.
CAUTION: Use special care in areas of diseased vessels to
avoid rupture or vessel trauma.
10.6
If balloon pressure is lost and/or balloon rupture occurs,
deflate the balloon and remove balloon. If required,
replace with a new Occlusion Balloon Catheter.
10.7
When balloon inflation is complete, draw a vacuum in the
balloon and verify that the balloon is fully deflated.
10.8
Maintain vacuum on the balloon and withdraw the
Occlusion Balloon Catheter back through the introducer
sheath. Use fluoroscopic imaging to track the movement
of the Occlusion Balloon Catheter throughout the
withdrawal.
10.9
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.
10.10
Remove introducer sheath and close entry site with
standard surgical closure technique.
Document Part Number: 3116-001, Rev 01 (05/2019)
Balloon Diameter
18 mm
20 mm
22 mm
24 mm
26 mm
28 mm
30 mm
31 mm
32 mm
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