Euphora™
Rapid Exchange Balloon Dilatation Catheter
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Trademarks may be registered and are the property of their respective owners.
Explanation of symbols on product labeling
Inflation Pressure
Balloon Length
Balloon Diameter
Open Here
Guide Catheter/Minimum Inner Diameter
Nominal Pressure
Rated Burst Pressure
Do Not Exceed Rated Burst Pressure
Maximum Guidewire Diameter
For Post Dilatation of Balloon Expandable Stents
Do Not Use if Package is Damaged
Consult Instructions for Use at this Website
Do Not Reuse
Use By
Lot Number
Catalog Number
Manufacturer
Sterilized Using Ethylene Oxide
For US Audiences Only
Manufactured In
Quantity
Recycle
Consult Instructions for Use
1
Rapid Exchange Balloon Dilatation Catheter (1.5 mm Diameter)
Figure 1
Rapid Exchange Balloon Dilatation Catheter (2.0 mm to 4.0 mm Diameter)
Figure 2
2
Euphora™
Rapid Exchange Balloon Dilatation Catheter
1. Medtronic Balloon Catheter Description
The Euphora™ Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA)
Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific
pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter
provides a lumen which enables the use of a guidewire to position the catheter.
Radiopaque balloon markers enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
Contents
One balloon dilatation catheter
One flushing cannula
One refold tool
One looper device
One compliance chart
2. Indications
■
The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft
stenosis for the purpose of improving myocardial perfusion.
■
The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for postdeployment expansion of
balloon expandable stents.
3. Contraindications
The catheter is contraindicated for use in:
■
unprotected left main coronary artery
■
coronary artery spasm in the absence of significant stenosis
4. Warnings
■
For single patient, single procedure use only. Do NOT resterilize or reuse the device. Resterilization or reuse may
compromise device performance and increase the risk of inappropriate resterilization and cross contamination.
■
Do not use the catheter if its package has been opened or damaged.
■
To reduce the potential for vessel damage the inflated diameter of the balloon should approximate the diameter of the
vessel just proximal and distal to the stenosis.
■
PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful
consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special
risk.
■
When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum as this can potentially
result in damage to the vessel wall. If resistance is met during manipulation, determine the cause of the resistance before
proceeding.
■
Balloon pressure should not exceed the rated burst pressure indicated on the package label for each balloon. The rated
burst pressure is based on the results of in vitro testing. Use of a pressure monitoring device is recommended to prevent
overpressurization.
■
PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly
performed in the event of a potentially injurious or life-threatening complication.
■
Use only the recommended balloon inflation medium. To prevent the possibility of an air embolus, never use air or any
gaseous medium to inflate the balloon.
■
Use the catheter prior to the Use By date specified on the package.
5. Precautions
■
Prior to angioplasty, examine the catheter to verify functionality and ensure that its size and shape are suitable for the
procedure for which it is to be used.
■
If the device is kinked, it should not be used.
■
The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary
angioplasty.
■
Administer appropriate anticoagulation, antiplatelet, and vasodilator therapy to the patient.
Instructions for Use English 3
Note: Testing without anticoagulation shows variable amounts of thrombus formation on the device surface.
Thrombogenicity evaluations conducted using a heparinized model do not indicate thrombus formation. If the patient is not
appropriately anticoagulated, thrombus formation may occur. Appropriate anticoagulation therapy should be administered to
reduce potential thrombosis.
■
When using two guidewires, use caution when introducing, torquing, and removing one or both guidewires to avoid
entanglement. It is recommended that one guidewire be completely withdrawn from the patient before removing any
additional equipment.
■
Do not apply excessive force during preparation or use, as this may damage the device.
■
The safety and effectiveness of this PTCA balloon catheter for the treatment of instent restenosis (ISR) have not been
established.
■
3.75 mm and 4.0 mm Euphora™ rapid exchange balloon models are not suitable for simultaneous use within a 2 mm
[6F/MGCID 1.8 mm (0.070”)] guide catheter. Refer to Section 9.
Note: In the case of simultaneous use of two Euphora™ balloon catheters in 1 guide catheter, care should be taken when
introducing, torquing and removing guide wires and balloon catheters to avoid entanglement.
6. Adverse Effects
Potential adverse effects seen during a PTCA procedure could be associated with this procedure. Possible adverse effects
include, but are not limited to:
■
death
■
acute myocardial infarction
■
total occlusion of the coronary artery or bypass graft
■
coronary vessel dissection, perforation, rupture, or injury
■
restenosis of the dilated vessel
■
hemorrhage or hematoma
■
unstable angina
■
arrhythmias, including ventricular fibrillation
■
drug reactions or allergic reaction to contrast medium
■
hypotension/hypertension
■
infection
■
coronary artery spasm
■
arteriovenous fistula
■
stroke, air embolism, and embolization or fragmentation of thrombotic or athlerosclerotic material
7. Materials To Be Used In Combination With A Balloon Catheter Include
■
suitable guidewire (refer to label claim)
■
20-ml syringe for balloon preparation
■
suitable guiding catheter (refer to label claim)
■
10-ml or smaller syringe for manual dye injections
■
appropriate inflation medium (eg, 50:50 sterile mixture of a contrast medium and saline)
Caution: Use of concentrations greater than a 50% solution of contrast medium may result in increased viscosity which
could prolong inflation/deflation times.
■
pressure-indicating inflation device
■
hemostasis valve
8. Instructions for Use
Note: Bench testing was conducted with the Euphora™ Rapid Exchange Balloon Dilatation Catheter and commercially
available Medtronic balloon expandable stents. Use caution when using this device with different manufacturers’ stents due to
difference in stent design. All stents should be deployed in accordance with the manufacturer's indications and instructions for
use.
8.1. Preparation
1. Select an appropriate balloon catheter for the target vessel.
Note: The Euphora™ device is compatible with a guide catheter minimum internal diameter of 0.056” (1.42 mm). Bench
test data have shown that the maximum balloon crossing profile for the Euphora™ balloon catheter is 0.044" (1.12 mm);
smaller balloons have lower crossing profiles.
2. Remove the device from the sterile packaging.
4 Instructions for Use English
3. Remove the device from its hoop (Figure 3, A).
4. While holding the catheter close to the balloon protector (Figure 3, C) gently slide the protector and stylette from the device.
Note: Avoid activation of the distal shaft coating prior to balloon sheath/stylette removal.
Note: Do not discard the balloon stylette until the end of the angioplasty procedure as it may be required for balloon
refolding.
5. Fill a 20-ml syringe with 20 ml of a saline solution.
6. Remove the flushing cannula (Figure 3, B) from the accessory clip and, without removing the cover, attach directly to the
syringe.
7. Remove the cover of the flushing cannula.
8. Insert the flushing cannula into the guidewire entry port (exchange joint).
9. Depress the syringe to flush the guidewire lumen until fluid emerges from the distal tip of the balloon catheter.
10. Remove the flushing cannula from the guidewire entry port (exchange joint).
Note: Do not discard the flushing cannula until the end of the angioplasty procedure as additional flushing may be required.
8.2. Balloon Purging
1. Purge air from the balloon catheter using a 20-ml syringe filled with 2 to 3 ml of the inflation medium with the balloon
catheter pointing downward.
2. Attach an inflation device to the balloon inflation port. Ensure that a meniscus of contrast medium is evident in both the
catheter luer connector and the inflation device.
3. Apply negative pressure with the inflation device. A flow of bubbles will move from the balloon catheter into the inflation
device. Balloon purging is complete when the flow of bubbles stops.
Caution: Do not attempt preinflation technique to purge the balloon lumen.
8.3. Insertion Technique
1. Place the guiding catheter, with a hemostasis valve attached, in the orifice of the target coronary artery.
2. Advance a guidewire through the guiding catheter to reach and cross the target lesion. Advance the distal tip of the balloon
catheter over the proximal end of the guidewire. Ensure that the guidewire exits the balloon catheter through the guidewire
exit port (exchange joint).
3. The hemostasis valve should be gradually tightened to control back flow. Excessive valve tightening may affect balloon
inflation/deflation time as well as movement of the guidewire.
4. Track the balloon catheter over the guidewire to cross the lesion using the radiopaque marker(s) to locate the balloon
across the lesion.
Precaution: If resistance is encountered do not use force to advance the device as this may result in damage to the
balloon catheter.
Note: Bench test data have shown that the average number of turns to failure (detachment) for the Euphora™ balloon catheter
is 49. It is recommended that you do not torque the device more than twice as this will result in the guidewire wrapping around
the catheter.
8.4. Balloon Inflation
1. Inflate the balloon to dilate the lesion using standard PTCA techniques.
2. After each subsequent inflation, assess the distal blood flow.
Note: If a significant stenosis persists, successive inflations may be required to resolve the stenosis. Do not exceed the
rated burst pressure (see compliance chart).
3. Confirm the results with fluoroscopy.
8.5. Catheter Removal
1. Apply negative pressure to the inflation device and confirm that the balloon is fully deflated.
Note: The maximum deflation time for the Euphora™ balloon catheter is ≤20 seconds; smaller balloons have shorter
deflation times.
2. Withdraw the balloon catheter into the guiding catheter while preserving guidewire position and adjusting the hemostasis
valve appropriately. Remove the balloon catheter from the system.
3. After the deflated balloon catheter is withdrawn, wipe it clean with gauze soaked with sterile normal saline.
4. Inspect the balloon catheter’s integrity.
Instructions for Use English 5
5. If reinserting the same balloon catheter, flush the guidewire lumen by using the flushing cannula to flush saline through the
D
2
2
A
B
C
1
1
D
E
F
guidewire entry port (exchange joint) until fluid emerges from the distal tip of the balloon catheter. Prior to reinsertion, wipe
the balloon catheter clean with gauze soaked with sterile normal saline. The balloon may be refolded using the refold tool
as described in the refold tool instructions for use (Section 8.6).
Figure 3.
8.6. Refold Tool
The refold tool (Figure 3, F) is an accessory component that allows the balloon to be refolded if required.
1. Deflate the balloon by applying negative pressure to the inflation device; maintain under vacuum.
2. Visually inspect the balloon to confirm that it is fully deflated.
3. Remove the refold tool from the compliance chart (Figure 3, E).
4. Ensure the balloon protector (Figure 3, C) is not on the balloon stylette and load the nonflared end of the refold tool onto
the straight end of the stylette.
5. Carefully load the stylette back through the distal tip of the balloon catheter and past the proximal end of the balloon.
6. While holding the balloon catheter just proximal to the balloon, push the refold tool over the balloon in a gentle twisting
motion until the entire balloon is covered.
7. Gently remove the refold tool and stylette.
8. Inspect the balloon and catheter for any potential damage. Discard the balloon catheter if there is any visible damage
present on the balloon.
8.7. Looper Device
The looper device (Figure 3, D) is an accessory component for use with Medtronic rapid exchange balloon catheters. The
device allows the balloon catheter to be fastened in a coiled configuration for ease of handling during use.
1. Remove the looper device from the accessory clip on the hoop (Figure 3, A).
2. Form the catheter into a single or double loop when required.
3. Hook the looper around the coiled proximal end of the catheter (Figure 3, D).
9. Instructions for Simultaneous Use of two Euphora™ Balloon Catheters in one Guide Catheter (Kissing
Balloon Technique)
Any combination of two Euphora™ rapid exchange balloon models 1.50 mm to 3.50 mm can be used simultaneously within a
2 mm [6F/MGCID 1.8 mm (0.070")] guide catheter.
9.1. Insertion Technique:
Insert the balloon catheters using the instructions provided in Section 8.3 “Insertion Technique”. Position one guide wire and its
associated balloon catheter at the first (1st) target site prior to inserting a second (2nd) guide wire and its associated balloon
catheter.
9.2. Balloon Inflation:
Inflate the balloon catheters using the instructions provided at Section 8.4.
9.3. Removing the Catheters:
Remove the balloon catheters using the instructions provided at Section 8.5. Remove one catheter and its associated guide
wire completely prior to removing the second catheter and its associated guide wire.
6 Instructions for Use English
10. References
The physician should consult recent literature on current medical practice on balloon dilatation, such as published by the
American College of Cardiology or the American Heart Association.
11. Compliance Chart
The Compliance Chart is based on actual data from in vitro testing at 37°C (99°F), rounded to two decimal places. Refer to
product labeling (Figure 3, E) and/or carton labeling to reference the Compliance Chart.
12. Disclaimer of Warranty
ALTHOUGH THE CATHETER, HEREAFTER REFERRED TO AS “PRODUCT,” HAS BEEN MANUFACTURED UNDER
CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC INC. AND ITS AFFILIATES HAVE NO CONTROL OVER
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC INC. AND ITS AFFILIATES, THEREFORE,
DISCLAIM ALL WARRANTIES, BOTH EXPRESSED AND IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. MEDTRONIC INC. AND ITS AFFILIATES SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY FOR ANY
MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE,
DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED
UPON WARRANTY, CONTRACT, TORT, OR OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BIND
MEDTRONIC INC. AND ITS AFFILIATES TO ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE
PRODUCT.
The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory
provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable, or in conflict
with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall
not be affected.
Instructions for Use English 7
Medtronic, Inc.
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USA
www.medtronic.com
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Tel. (888) 283-7868
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