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Quantity Description
1
Femoral or radial guide catheter access to the target vessel,
minimum I.D. = 0.058 in (1.47 mm)
As Needed Contrast media
1
Inflation device
1
≤0.014 in (0.36 mm) guidewire
1
10 ml, 12 ml, or 20 ml (10 cc, 12 cc, or 20 cc) luer-lock syringe
1
Hemostatic adapter
1
Three-way stopcock
Prior to angioplasty, carefully examine all equipment to be used during the procedure,
including the dilation catheter, to verify proper function. Verify that the catheter and
sterile packaging have not been damaged in shipment and that the catheter size is
suitable for the specific procedure for which it is intended.
Note: At any time during use of the Maverick
stainless steel proximal shaft has been bent or kinked, do not continue to use the catheter.
Preparation
1. Inflation Device Preparation
a. Prepare the inflation device according to the manufacturer's instructions.
b. Purge the system of air.
2. Dilation Catheter Selection
The inflation diameter of the balloon must not exceed the diameter of the coronary
artery proximal and distal to the stenosis. If the stenosis cannot be crossed with the
desired dilation catheter, use a smaller diameter catheter to predilate the lesion to
facilitate passage of a more appropriately sized dilation catheter.
3. Dilation Catheter Preparation
a. Remove catheter from the protective hoop.
b. Remove the balloon protector and mandrel by grasping the balloon dilation
catheter just proximal to the balloon, and with the other hand, gently grasp the
proximal section of the balloon protector and slide distally; remove the mandrel
distally after removing the balloon protector. If unusual resistance is felt
during the product mandrel and/or balloon protector removal, do not use
this product and replace with another.
c. Prepare the balloon dilation catheter for purging. Fill a 10 ml, 12 ml, or 20 ml
(10 cm
3
(cc), 12 cm
3
of contrast medium. Use only appropriate balloon inflation medium (e.g., the
equivalent of a 50:50 mixture of contrast medium and sterile saline). Never use
air or any gaseous medium to inflate the balloon.
d. Connect a three-way stopcock to the port fitting on the dilation catheter. Flush
through the stopcock.
e. Connect the syringe to the stopcock.
f. Hold the syringe with the nozzle pointing downward and aspirate for 5 seconds.
Release the plunger.
g. Remove the syringe and evacuate all air from the barrel.
h. Reconnect the syringe and aspirate until bubbles no longer appear during
aspiration. If air bubbles persist despite verification of a luer-lock seal, do not
use the device.
39
MB Drawing 50573139
2
Monorail PTCA Dilatation Catheter, if the
(cc), or 20 cm
3
(cc)) luer-lock syringe with 3 ml (3 cm
i. Release plunger and set aside until step 4b.
j. Carefully flush the guidewire lumen of the balloon catheter with sterile saline
through the distal tip of the catheter.
4. Inflation Device Connection to Catheter
a. To remove any air lodged in the distal luer fitting of the inflation device, purge
approximately 1 ml (1 cc) of inflation medium.
b. Disconnect the syringe used in preparation, taking care to completely fill the
hub with fluid. A meniscus should appear in the balloon port when the syringe
is removed. Verify that a meniscus of inflation medium is evident in both the
dilation catheter balloon port and the inflation device connection. Securely
couple the inflation device to the balloon port of the balloon dilation catheter.
Procedure
5. Use of the Maverick
2
a. Insert a guidewire through the hemostatic adapter following the manufacturer's
instructions or standard practice. Advance the guidewire carefully into the
guiding catheter.
b. Under fluoroscopic guidance, position the guidewire across the lesion and park
the wire tip in the distal vessel.
c. Backload the distal tip of the dilation catheter onto the guidewire ensuring the
guidewire exits the midsection opening in the catheter.
Note: To avoid kinking, advance the dilation catheter slowly, in small
increments until the proximal end of the guidewire emerges through the
catheter guidewire port.
d. Thoroughly aspirate and flush the guiding catheter in preparation for
introduction of the dilation catheter.
e. While the balloon is fully deflated, advance the catheter through the hemostatic
valve slowly. If resistance is encountered, do not advance the dilation catheter
through the adapter. Caution should be taken not to over-tighten the
hemostatic adapter around the dilation catheter shaft, as lumen constriction
may occur, affecting inflation/deflation of the balloon.
f. Connect the side port of the guiding catheter hemostatic adapter to the pressure
recording/infusion line or manifold assembly, which permits pressure recording
or infusion through the guiding catheter.
g. Position the balloon relative to the lesion to be dilated and inflate the balloon
to the appropriate pressure (reference balloon compliance table). Maintain
3
(cc))
negative pressure on the balloon between inflations.
h. Withdraw the deflated dilation catheter from the guiding catheter through the
hemostatic valve. Tighten the knurled knob on the hemostatic valve.
i. Assess the dilated lesion for patency, distal flow and vessel injury (including
guide catheter trauma).
j. The catheter may be coiled once and secured using the CLIPIT Clip provided in
the catheter package. Only the hypotube should be inserted into the coil clip;
the clip is not intended for the distal end of the catheter.
Note: Care should be taken not to kink or bend the shaft upon application or
removal of the coil clip.
5
Monorail PTCA Dilatation Catheter
Black (K) ∆E ≤5.0
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