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Micra™ Introducer
Introducer Sheath with Hydrophilic Coating
Instructions for Use
[insert CE mark]
Caution: Federal (USA) law restricts this device
to sale by or on the order of a physician.
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The following list includes trademarks or registered trademarks of
Medtronic in the United States and possibly in other countries. All other
trademarks are the property of their respective owners.
Medtronic, Micra
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Explanation of symbols on product labeling
Refer to the device labeling to see which symbols apply to this product.
Lot number
Catalogue number
Use by
Manufacturer
Do not use if package is damaged
Do not reuse
Sterilized using irradiation
Nonpyrogenic
Contents: one device
Manufactured in
Inner di ameter
Length
Maximum guidewire diameter
Open here
Consult instructions for use at:
CAUTION: Federal (USA) law restricts this device to sale by or on the order
of a physician.
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Micra Introducer
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Introducer Sheath with Hydrophilic Coating
1 Device Description
The Micra introducer (Figure 1) is a single-use, disposable, hydrophilically coated sheath that provides a
flexible and hemostatic conduit for the insertion of intravascular devices into the venous system to minimize
blood loss. The system is comprised of 2 components: a dilator that accommodates a 0.035 in (0.89 mm)
guidewire and an introducer.
The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the
vasculature. A female luer taper fitting is located on the proximal end of the dilator grip. The distal end of the
dilator grip is threaded to allow the dilator to be secured to the sheath seal housing.
The introducer is comprised of a hydrophilically coated, coil-reinforced sheath that is attached to a rigid seal
housing containing the hemostatic valve assembly. A sideport extension with a 3-way valve is permanently
attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The
introducer also has a suture loop for attaching it to the patient and a strain relief to prevent kinking of the
sheath where it joins to the seal housing.
1 Dilator grip female luer taper thread
2 Dilator grip
3 Seal housing with hemostatic valve assembly (sheath hub)
4 Strain relief
5 Suture loop
6 Sideport extension with 3-way valve
7 Introducer
8 Introducer sheath
9 Dilator
10 Dilator tapered tip
Figure 1. Micra introducer sheath
Note: Graphical representation not drawn to scale.
This device does not contain natural rubber latex; however, during the manufacturing process, it may have
incidental contact with latex.
2 Indications for Use
The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system and
to minimize blood loss associated with such insertions.
3 Contraindications
There are no known contraindications with this device. It is not intended for use except as indicated.
4 Warnings and Precautions
Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions
may lead to serious consequences or injury to the patient.
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Do not alter this device. Alterations may impair device function.
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Do not cut or puncture the sheath. This could result in major blood loss and vessel trauma.
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Do not use after the Use By date printed on the label.
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This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a
risk of contamination of the device, which could result in patient injury, illness, or death.
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After use, dispose of the device in accordance with hospital, administrative, or government policies.
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The dilator is only compatible with a 0.035 in (0.89 mm) guidewire.
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Verify sheath, device, catheter, and accessory components size compatibility prior to use. The maximum
diameter and length of the instrument or catheter to be introduced should be determined to ensure its
passage through the sheath. Introduction of a smaller intravascular device may result in increased blood
loss. Note: The length of the sheath does not include the strain relief.
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If scar tissue is present, predilatation may be required.
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Adequate vessel access is required to introduce the sheath into the vasculature. Careful evaluation of
vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is
required to ensure successful sheath introduction and subsequent withdrawal. If vessel is not adequate
for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.
If vessel size is smaller than the introducer sheath's outer diameter, major bleeding, vessel damage, or
serious injury to the patient, including death, may result.
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When inserting, manipulating, or withdrawing a device through the sheath, always maintain sheath
position.
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When puncturing, suturing, or incising the tissue near the sheath, use caution to avoid damaging the
sheath.
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Do not attempt to insert or withdraw the introducer sheath if resistance is felt. The cause of the resistance
must be determined before proceeding.
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Do not attempt to simultaneously insert multiple catheters or interventional devices into the sheath.
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Advance and withdraw the sheath (with the dilator fully inserted and locked in) only under fluoroscopic
guidance.
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Ensure that the dilator is fully inserted into the introducer to minimize the risk of vascular injury.
5 Adverse Events
5.1 Potential Adverse Events
Adverse events or complications associated with use of the Micra introducer include, but are not limited to:
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allergic response to materials
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blood loss, bleeding, or hematoma
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embolization (micro or macro) with transient or permanent ischemia
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infection
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vascular trauma (eg, dissection, rupture, perforation, or tear)
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death
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6 How Supplied
6.1 Sterility
The Micra introducer is individually packaged. It is supplied sterile (electron beam) for single use only.
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Do not reuse or attempt to resterilize.
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If the device is damaged or the integrity of the sterilization barrier has been compromised, do not use and
contact a Medtronic representative for return information.
6.2 Contents
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1 Micra introducer with dilator
6.3 Storage
Store the Micra introducer at room temperature in a dark, dry place to avoid extended exposure to light and
moisture.
7 Clinical Use Information
7.1 Physician Training Requirements Caution: The Micra introducer should only be used by physicians and teams trained in vascular
interventional techniques and in the use of similar devices.
7.2 Device Insp ection
Carefully inspect the device and packaging for damage or defects prior to use. If the Use By date has
elapsed, the device is damaged, or the sterilization barrier has been compromised, do not use the device.
Contact a Medtronic representative for return or replacement.
7.3 Additional Equipment Recommended
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0.035 in (0.89 mm) guidewire
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heparinized saline solution
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35 cc or larger syringe
8 Instructions for Use
1. Remove device from package and ensure that the inner diameter (ID) of the sheath is appropriate for the
maximum diameter of the intravascular device to be introduced.
2. Verify the vessel is of adequate diameter and tortuosity to accommodate the introducer sheath.
3. Open the 3-way valve on the sideport extension.
4. Connect a syringe of heparinized saline solution to the luer fitting on the sideport extension and flush the
sheath, tapping the introducer sheath to aid in releasing air bubbles.
5. Close the 3-way valve on the sideport extension.
6. Connect a syringe of heparinized saline solution to the luer fitting on the dilator and flush the dilator.
7. Insert the dilator completely into the introducer sheath and secure by rotating the dilator grip clockwise,
approximately one-quarter turn.
8. Follow accepted clinical practice for vessel access and guidewire insertion.
9. Activate the hydrophilic coating by wetting the outer surface of the sheath with heparinized saline. Note:
For best results, ensure the device remains wet during placement.
10. Advance the sheath with dilator as a unit over the guidewire under fluoroscopic guidance to the desired
location. Stop advancement if there is resistance and investigate the cause of the resistance before
proceeding.
11. Hold the sheath steady while unlocking and withdrawing the dilator and the guidewire from the sheath
until the dilator and guidewire are completely removed from the sheath.
12. Before removing or inserting devices through the introducer, aspirate at least 30 cc through the side arm
of the valve to clear the introducer of air. Then flush with heparinized saline.
13. Attach a continuous heparinized saline drip to the sideport extension on the introducer to reduce the risk
of thromboembolism.
14. Interventional devices can be interchanged as necessary.
15. Upon removal of the sheath, take precautions to prevent bleeding, vessel damage, or other serious injury.
Advancing the guidewire supported by the dilator into the sheath prior to withdrawing the sheath may aid
in withdrawal from the vasculature.
9 Disclaimer of Warranty
ALTHOUGH THE MICRA INTRODUCER HAS BEEN MANUFACTURED UNDER CAREFULLY
CONTROLLED CONDITIONS, MEDTRONIC, INC., MEDTRONIC VASCULAR, INC. AND THEIR
RESPECTIVE AFFILIATES (COLLECTIVELY “MEDTRONIC”) HAVE NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS ALL
WARRANTIES, BOTH EXPRESSED AND IMPLIED, WITH RESP ECT TO THE PRODUCT, INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. MEDTRONIC 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 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, and all rights and obligations
shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term
held to be invalid.
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Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel. +1 763 514 4000
Fax +1 763 514 4879
Technical manuals
www.medtronic.com/manuals
© Medtronic, Inc. 2013
M954208A001B
2013-10-04
*M954208A001*
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