English - ev3 Marathon Instrucciones De Uso

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Instructions for Use
Marathon™ Flow Directed Micro Catheter
CAUTION
Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.
This device should be used only by physicians with a thorough understanding of angiography and
percutaneous interventional procedures.
CONTENTS
• One Marathon™ Micro Catheter
• Shaping Mandrel
ACCESSORIES:
(May be included with device model.)
• 0.007" Stylet or smaller
• 0.010" Micro Guidewire or smaller
• 1.5F Introducer Sheath or larger
DESCRIPTION
The Marathon™ Flow Directed Micro Catheter is a single-lumen, endhole catheter designed for the
subselective infusion of physician-specified therapeutic agents such as embolization materials and
diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid
proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy.
The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of
accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization.
The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet,
guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the
guiding catheter.
INDICATIONS FOR USE
The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for
the controlled selective infusion of physician-specified therapeutic agents such as embolization materials
and of diagnostic materials such as contrast media.
CONTRAINDICATIONS
• The Marathon™ Flow Directed Micro Catheter is contraindicated when, in the medical judgment of
the physician, use of such product may compromise the patient's condition.
• Not intended for use in the coronary vasculature.
• The Marathon™ Flow Directed Micro Catheter is contraindicated for neonatal and pediatric use.
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to:
• Puncture site hematoma
• Vessel perforation
• Vessel spasm
• Hemorrhage
WARNINGS
• Infusion pressure with this device should not exceed 690 kPa/100 psi. Pressure in excess of 690
kPa/100 psi may result in catheter rupture, possibly resulting in patient injury.
• If flow through the catheter becomes restricted, do not attempt to clear the device by high pressure
infusion. Either remove the catheter to determine the cause of the obstruction or replace it with a
new catheter. Excessive pressure may cause catheter rupture, possibly resulting in patient injury.
• Never advance or withdraw an intraluminal device against resistance until the cause of the resistance
is determined by fluoroscopy. Excessive force against resistance may result in damage to the device
or vessel perforation.
• When injecting contrast for angiography, ensure that the catheter is not kinked, prolapsed or
occluded. Remove excess slack in the catheter to reduce the potential for catheter kink or prolapse.
• Verify catheter integrity prior to re-inserting guidewire or injecting embolic material to prevent
vascular damage or unintended embolization. Catheter integrity is verified by angiographically
confirming that contrast agent is exiting only from the catheter tip while viewing the entire distal
section of the catheter.
• Do not "over-shape" the catheter to achieve the desired shape angle. Over-shaping can lead to
catheter kink or prolapse.
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and
re-sterilization increase the risks of patient infection and compromised device performance.
• Pain and tenderness
• Thrombolytic episodes
• Neurological deficits including stroke and death
• Vascular thrombosis
• The stylet (supplied with some models) is not to be used as a guidewire. The stylet should never be
EN
manipulated within the catheter. Do not advance the stylet beyond the tip of the catheter.
Use of the stylet as a guidewire could cause damage to the catheter and/or injure the patient.
PRECAUTIONS
• Prior to use, carefully examine the Marathon™ and its packaging to verify that they have not been
damaged during shipment.
• Prior to use, all accessory devices and agents should be fully prepared according to the
manufacturer's instructions.
• Always monitor infusion rates when using this catheter.
• The Marathon™ has a hydrophilic coating on the outside of the catheter which must be kept
hydrated.
• This catheter is not intended for use with chemotherapy agents.
• When the infusion catheter is in the body, it should be manipulated only under fluoroscopy. Do not
attempt to move the catheter without observing the resultant tip response.
• Because the Marathon™ may be easily advanced into narrow, selective vasculature, repeatedly
verify that the Marathon™ has not been advanced so far as to interfere with its removal by slightly
withdrawing the catheter before each infusion.
• When performing angiography, it is recommended to use a 3cc syringe rather than a 1cc syringe to
reduce the risk of catheter over-pressurization.
• The Marathon™ is a flow directed micro catheter that can optionally be used with hydrophilic,
0.010" or less sized guidewires. The Marathon™ is not compatible with non-hydrophilically coated
guidewires greater than 0.010" in diameter.
• It is recommended that the Marathon™ be used with an appropriately sized guiding catheter which
allows adequate clearance (minimum internal diameter of 0.053" or 1.35mm).
STORAGE
Store the Marathon™ Flow Directed Micro Catheter in a dry place between 50°F (10°C) and 90°F (32°C).
DIRECTIONS FOR USE
Marathon™ Flow Directed Micro Catheter
1. Place the appropriate guiding catheter following recommended procedures. Connect a one-way
stop-cock to the guiding catheter to prevent backflow of blood during insertion of catheter.
Connect a hemostatic side arm adapter one-way stop-cock to allow for insertion of catheter and to
continuously flush the guiding catheter with saline.
NOTE: It is recommended that a guiding catheter with minimum internal diameter of 0.053"
(1.35mm) be used with the Marathon™ Flow Directed Micro Catheter.
2. Gently remove the packaging coil for the Marathon™ Flow Directed Micro Catheter from the package.
3. Flush the coil with saline through the female luer attached to the coil.
4. Remove the catheter by removing the hub from the clip and gently pulling on the hub.
5. Inspect the catheter prior to use to verify that it is undamaged. Retain the packaging coil for storage
of the catheter when it is not in use during the procedure.
6. Flush the ID of the micro catheter coil with saline.
7. To assist with insertion of the microcatheter in to the hub, the following accessories may be used: a
guidewire, stylet, and/or introducer sheath.
8. If using a stylet and/ or guidewire:
• Prepare stylet or guidewire per manufacture's instructions; product should be hydrated.
• Remove the stylet or guidewire from its packaging coil
• Insert the stylet or guidewire through the hub of the Micro Catheter.
• Advance the stylet or guidewire through the catheter, keeping the catheter body straight. Do
not advance the stylet past the tip of the catheter.
• Close the one-way stop-cock.
• Loosen the hemostatic valve.
• Introduce the catheter through the hemostatic adapter.
• Tighten the valve around the catheter to prevent backflow, but allowing some movement
through the valve by the catheter.
• Open the one-way stop-cock.
• Advance the catheter such that the stylet or guidewire remains in the guiding catheter. Do not
advance the stylet past the tip of the guiding catheter.
• Once the catheter has been advanced to the end of the guiding catheter, if using a stylet
withdraw the stylet from the catheter.
9. The catheter may be advanced through the vasculature by gently pushing the proximal shaft. It is
recommended to use a guidewire during navigation to reduce the risk of catheter kink or prolapse.
WARNING: Verify catheter integrity prior to re-inserting guidewire or injecting embolic material
to prevent vascular damaged or unintended embolization. Catheter integrity is verified by
angiographically confirming that contrast agent is exiting only from the catheter tip while viewing
the entire distal section of the catheter.
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