Alvimedica Invader PTCA Instructions D'utilisation page 5

ENGLISH
INVADER™ PTCA BALLOON DILATATION CATHETER
HYDROPHILIC-COATED PTCA BALLOON DILATATION CATHETER
DESCRIPTION
INVADER™ PTCA Balloon Dilatation Catheter is a single use, Ethylene
Oxide (EO) sterilized, monorail rapid exchange (RX) coronary angioplasty
balloon dilatation catheter. The ALVIMEDICA INVADER™ PTCA has been
designed to dilate the stenotic atherosclerotic lesions in coronary arteries
or bypass grafts.
The dilation part of the catheter is the balloon near the distal tip.
The catheter is hydrophilic coated on the distal shaft excluding the
balloon. Radiopaque marker bands are located on both the proximal
and distal shoulders of the balloon. Two depth markers, on the proximal
shaft aid in determining when the balloon is exiting the guiding catheter,
in the cases of brachial or femoral approach, respectively. A separate
lumen on the catheter shaft is intended for use as a guidewire lumen
beginning at approximately 27 cm from the distal tip. The PTFE coated
proximal end of the catheter is used as the balloon inflating port.
The balloon is inflated by injecting a contrast material from this end.
The balloon material can be inflated to a given size at a given pressure.
The size matrix and device features are as below:
Table 1. The size matrix and device features of INVADER™ PTCA Balloon
Dilatation Catheter
Balloon Minimum
Outer Balloon Guiding
Diameter Length (mm) Catheter
(mm) Compatibility ID
6, 10, 12, 5F (1.4 mm /
1.25
15, 20 0.056")
6, 10, 12, 5F (1.4 mm /
1.50
15, 20 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.00
20, 25 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.25
20, 25 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.50
20, 25, 30, 34 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.75
20, 25, 30, 34 0.056")
6, 10, 12, 15, 5F (1.4 mm /
3.00
20, 25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
3.25
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
3.50
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
3.75
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
4.00
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
4.50
25, 30, 34 0.056")
5F (1.4 mm /
5,00 10, 12, 15, 20
0.056")
INDICATIONS
The INVADER™ PTCA Balloon Dilatation Catheter is intended to be used
for dilating stenoses in the coronary artery or bypass graft so as to
increase myocardial perfusion.
• Patients should be eligible for coronary bypass surgery.
• It is indicated for patients with single-artery non-calcified atheroscle-
rotic lesions that can be dilated using a PTCA catheter.
• This procedure can also be indicated in certain patients who have
multi-artery disease, and in patients who have undergone aorta-
coronary bypass surgery but still have:
> recurrent symptoms;
> progressive coronary artery disease;
> stenosis or obstruction in bypass grafts.
CONTRAINDICATIONS
The INVADER™ PTCA Balloon Dilatation Catheter is contraindicated in
patients:
• who are not eligible for coronary bypass surgery;
• who have fully obstructed coronary arteries;
• who have diffuse lesions;
• who have severe stenosis of the left main coronary artery.
WARNINGS / PRECAUTIONS
• The INVADER™ PTCA Balloon Dilatation Catheter has been designed
for single use only, reuse is not recommended. Do not resterilize it.
• Keep the catheter in a cool, dry and dark place.
• Do not use the catheter after the expiry date printed on the
packaging.
• Use diluted contrast material only.
• Do not use air or any other gas to inflate the balloon.
• Check the packaging for any damage.
• Do not exceed the rated burst pressure as indicated in the Instructions
For Use when inflating the balloon.
• Use of an inflation device with an incorporated pressure gauge is
recommended.
• The diameter of the inflated balloon should not be exceeded at the
points just proximal and distal to the stenosis.
• The INVADER™PTCA Balloon Dilatation Catheter should only be used by
experienced physicians who have been trained in PTCA operations.
• Give appropriate anticoagulation and vasodilatation therapy prior
to catheterization.
• The PTCA operation should only be performed in medical centers
capable of carrying out emergency coronary bypass surgery in case
of severe complications.
• Do not tighten the hemostatic adapter in the Y-connector, as this can
compress the shaft, thus impeding the inflation and deflation of the
balloon.
Rated
Nominal
• All procedures performed once the catheter has been introduced into
Burst
Pressure
the body should be carried out under quality fluoroscopy. Never pull
Pressure
(bar)
(bar) or push the catheter unless the balloon has been fully deflated under
vacuum. If any resistance is encountered during the procedure, simply
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stop and try to identify the cause and then gradually advance the
balloon catheter to prevent the occurrence of kinking on the proximal
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shaft. If you fail to identify the cause, remove the entire system.
• Do not use the contrast materials Ethiodol or Lipiodol.
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• Do not expose the insertion system to organic solvents (i.e. alcohol, etc.)
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The product might be a potential biohazard, after use. The product
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must be handled and disposed of in accordance with accepted medi-
cal practice, applicable local laws and regulations. Alvimedica is not
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responsible for the handling and disposal of the product after use.
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ADVERSE EFFECTS / COMPLICATIONS
• Dissection of the coronary artery
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• Tearing, perforation of, or damage to the coronary artery
• Complete obstruction of the coronary artery or bypass graft
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• Thrombosis of the coronary artery
• Unstable angina
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• Acute myocardial infarction
• Restenosis of the dilated artery
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• Spasm of the coronary artery
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• Hemorrhage and hematoma
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• Drug reactions, allergic reaction to contrast material
• Hypertension - hypotension
• Infection
• Arteriovenous fistula
• Embolism
• Death
• Urgent coronary artery bypass graft surgery
• Renal failure
INSTRUCTIONS FOR USE
Auxiliary material (not included in the package)
- Guiding catheter(s) with a 5F diameter (1.422 mm) or larger
- Syringes
- Guidewires 0.014 inches (0.356 mm) in diameter or less
- Inflation device
- Introducer sheath
a. Selecting the right size
The diameter of the balloon should be selected so that, when it is inflated
at nominal pressure, it will not exceed the coronary artery diameter at
the points just proximal and distal to the stenosis.
b. Preparation
• Prepare an inflation solution of a 1:1 mixture of contrast material and
sterile saline solution.
• Fill a 20 cc syringe with approximately 10 cc of the saline solution.
• Place a needle on the syringe and then carefully insert the needle
through the distal tip of the catheter and flush the guidewire lumen.
• Attach a stopcock to the hub of the INVADER™ PTCA Balloon Dilatation
Catheter.
• Attach the syringe to the stopcock and then hold the syringe vertically so
that its plunger is at the top. Pull the plunger and purge the balloon of air.
• Apply a vacuum using the syringe for 15-20 seconds and make sure
that no air bubbles pass through the diluted contrast material.
• Carefully stop vacuuming.
• Repeat the process if required.
• Exert negative pressure and then switch off the stopcock.
• Make sure that no air enters the system; attach the inflation device to
the catheter. Switch on the stopcock, inflate the balloon to nominal
pressure and then check the integrity of the INVADER™ PTCA Balloon
Dilatation Catheter.
• Exert negative pressure and then switch off the stopcock.
c. Insertion
• Using a hemostatic valve, attach the Y-connector to the guiding
catheter already inserted in the femoral artery.
• Pass the guidewire (maximum 0.014" (0.356 mm)) through the guiding
catheter, advance it and then place it as required.
• Gently tighten the hemostatic valve of the Y-connector on to the
guidewire so as to prevent unintended movement of the guidewire.
• Insert the rear tip of the guidewire through the distal tip of the catheter
and attach it to the catheter. The rear tip of the guidewire will come
out at approximately 27 cm proximal to the catheter's distal tip.
WARNING: Kissing balloon: bench tests has shown that two INVADER™
PTCA Balloon Dilatation Catheter with a diameter 4mm can be intro-
duced in 6F (or larger) guide catheter.
• Loosen the hemostatic valve of the Y-connector and advance the
INVADER™ PTCA Balloon Dilatation Catheter towards the distal part
of the guiding catheter.
WARNING: always advance the INVADER™PTCA Balloon Dilatation
Catheter when it is deflated and is on the guidewire.
• Do not tighten the hemostatic valve of the Y-connector too much,
as this may prevent the passage of the contrast material through
the balloon inflation lumen, thus resulting in the prolongation of the
deflation/inflation time of the balloon.
• Using standard angioplasty techniques, continue the procedure under
fluoroscopy. Radiopaque markers can help to better position the
balloon in the stenosis.
Note: It is recommended that the guidewire and/or balloon catheter
remain in the lesion until the dilatation is complete. Variations in the
viscosity of the contrast material may affect the deflation/inflation time.
d. Removal
• Loosen the hemostatic valve of the Y-connector.
• Hold the hemostatic valve and the guidewire with one hand and the
shaft of the catheter with the other.
• Whilst keeping the guidewire immobile in order to maintain its position
in the coronary artery, remove the dilatation catheter from the guiding
catheter.
Note: During removal, check the position of the guidewire by means
of fluoroscopy.
• Switch on the hemostatic valve of the Y-connector.
• If necessary, prepare another INVADER™ PTCA Balloon Dilatation
Catheter and repeat the dilatation process.
TERMS OF THE WARRANTY
Alvimedica guarantees that each and every component of this prod-
uct has been manufactured, packed, tested and sterilized without
any defect to its workmanship or material. Each product has been
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