Abbott Armada 14 XT Manual Del Usuario página 7

• Death
• Embolism (air, tissue, thrombotic, systemic or device
component)
• Fever / pyrogenic reaction
• Hypersensitivity or allergic reaction to contrast agents and
drug reactions
• Hypertension / hypotension
• Infection
• Ischemia, including tissue ischemia, steal syndrome, and
necrosis
• Leg edema
• Myocardial ischemia or infarction
• Nausea and vomiting
• Neuropathies or nerve injury
• Occlusion
• Organ failure (single, multiple)
• Pain
• Palpitations
• Pseudoaneurysm
• Renal failure / insufficiency
• Restenosis
• Stroke / cerebrovascular accident (CVA)
• Vascular complications, including entry site, which may
require vessel repair
• Vascular thrombosis
• Vessel injury, e.g. dissection, perforation
• Vessel spasm
MATERIALS REQUIRED
Single-Use, Sterile Items (Do not resterilize or reuse.)
• Sterile heparinized normal saline (HepNS)
• 4F-sized introducer sheath or 5F guiding catheter in the
appropriate size and configuration
• One inflation device (with pressure monitoring –
recommended)
• One 3-way stopcock
• 0.014" (0.36 mm) guide wire
• Contrast diluted 1:1 with normal saline
• Guide wire introducer
• Hemostatic valve(s)
• Guide wire torque device
• 20 cc Luer lock syringes (optional)
PREPARATION FOR USE
Inspect all product prior to use. Examine the Armada 14 XT PTA
Catheter (the catheter) for bends, kinks, or other damage. Do
not use if the package is open or damaged, or if the product is
damaged.
Prepare equipment to be used following manufacturer's
instructions or standard procedure.
Complete the following steps to prepare the catheter for use:
1. Remove the protective mandrel from the distal tip of the
catheter.
2. Slide the protective sheath off the balloon.
Note: Submerge the balloon in sterile heparinized normal
saline during balloon preparation to activate the coating.
3. Prepare an inflation device with the recommended contrast
medium according to the manufacturer's instructions.
4. Evacuate air from the balloon segment using the following
procedure:
a) Fill a 20 cc syringe or the inflation device with
approximately 4 cc of the recommended contrast
medium.
b) After attaching the syringe or inflation device to the
balloon inflation lumen, orient the catheter with the
distal tip and the balloon pointing in a downward vertical
position.
c) Apply negative pressure and aspirate for 15 seconds.
Slowly release the pressure to neutral, allowing contrast
to fill the shaft of the catheter.
d) Disconnect the syringe or inflation device from the
inflation port of the catheter.
e) Remove all air from the syringe or inflation device barrel.
Reconnect the syringe or inflation device to the inflation
port of the catheter. Maintain negative pressure on the
balloon until air no longer returns to the device.
f) Slowly release the device pressure to neutral.
g) Disconnect the 20 cc syringe (if used) and connect
the inflation device to the inflation port of the catheter
without introducing air into the system.
CAUTION: All air must be removed from the balloon and
displaced with contrast medium (diluted 1:1 with normal
saline) prior to inserting into the body (repeat steps 4a
through 4g, if necessary); otherwise, complications may
occur.
INSTRUCTIONS FOR USE
1. Flush and fill the guide wire lumen of the catheter with
heparinized normal saline.
2. Place the prepared catheter over a pre-positioned guide
wire and advance the tip to the introduction site. It is
advantageous to use the balloon catheter with an introducer
to facilitate entry.
Note: Perform all further catheter manipulations under
fluoroscopy.
3. Open the hemostatic valve. Insert the catheter over the guide
wire through the hemostatic valve into the sheath / guiding
catheter. To facilitate insertion, the balloon must be fully
deflated to negative pressure.
Note: Shaft diameter differences should be taken into
consideration when opening and tightening the hemostatic
valve and upon withdrawal of the catheter.
4. Tighten the hemostatic valve to create a seal around the
catheter without inhibiting movement of the catheter.
Note: It is important that the hemostatic valve be closed
tightly enough to prevent blood leakage around the catheter
shaft, yet not so tight that it restricts the flow of contrast into
and out of the balloon or restricts guide wire movement.
5. Advance the catheter until the distal shaft marker aligns with
the hemostatic valve hub. This indicates that the catheter tip
has reached the sheath / guiding catheter tip when using a
90 cm long sheath / guiding catheter.
Note: The Armada 14 XT PTA Catheter is designed to allow
the exchange of guide wires while maintaining position
of the catheter in the artery. In cases of extreme vessel
tortuosity, it may be necessary to reposition the catheter in
a straight segment of the vessel in order to allow guide wire
exchange.
6. Balloon should be of appropriate size for vessel. Larger
balloons will have larger crossing profiles (up to 0.048" /
1.22 mm) and smaller balloons will have smaller profiles.
Advance the catheter over the guide wire and into the
stenosis (or stent for post-implant dilatation). Inflate the
balloon to a very low pressure (1 atm or 1 bar or 15 psi) to
confirm that the balloon is correctly positioned.
7. Inflate the balloon (not to exceed 10 total inflations in a stent
or 20 total inflations without a stent) to perform PTA (or
post-implant dilatation) per standard procedure. Maintain
negative pressure on the balloon between inflations.
8. Deflate the balloon by applying negative pressure to the
inflation device. Larger and longer balloons will take more
time (up to 30 seconds) to deflate than smaller and shorter
balloons. Withdraw the deflated catheter and guide wire
from the sheath / guiding catheter through the hemostatic
valve. Tighten the hemostatic valve (if applicable).
Note: After the deflated balloon catheter is withdrawn,
it should be wiped clean with gauze soaked with sterile
heparinized normal saline and stored, submerged in a basin
of sterile heparinized normal saline. Prior to reinsertion, the
balloon should be submerged in sterile heparinized normal
saline to reactivate the coating.
Note: If resistance is felt during removal of either the
balloon catheter from the guide wire or the guide wire from
the balloon catheter, the balloon catheter and guide wire
should be removed together as a unit and set aside. Neither
balloon catheter nor the guide wire should be re-used for
additional attempts to dilate the artery, either separately or
in combination.
REFERENCES
The physician should consult recent literature on current
medical practice on balloon PTA.
PATENTS AND TRADEMARKS
This product and / or its use may be covered by one or more
of the following United States Patents: 5,480,383; 5,496,275;
5,525,388; 5,533,968; 5,554,121; 6,059,748; 6,139,525;
6,165,152; 6,179,810; 6,200,325; 6,206,852; 6,217,547;
6,221,425; 6,224,803; 6,238,376; 6,251,094; 6,368,301;
6,488,688; 6,572,813; 6,579,484; 6,589,207; 6,835,059;
6,964,750; 7,273,487; 7,322,959; 7,549,975; 7,662,130;
7,828,766; 7,833,597; 7,862,541. Other U.S. patents pending.
Foreign patents issued and pending.
ARMADA and HYDROCOAT are trademarks of the Abbott Group
of Companies.
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