Sentrant™
Introducer Sheath with Hydrophilic Coating
Instructions for Use
© 2017 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic
company.
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EXPLANATION OF SYMBOLS ON PRODUCT LABELING
Refer to the device labeling to see which symbols apply to this product.
Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Council Directive: 93/42/EEC.
Consult instructions for use at this website
Lot number
Catalogue number
Use by
Manufacturer
Do not use if package is damaged
Do not reuse
Sterilized using ethylene oxide
Nonpyrogenic
Quantity
Manufactured in
Maximum guidewire diameter
Date of manufacture
For US audiences only
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Sentrant™
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5
2
6
3
4
1
7
8
9
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Introducer Sheath with Hydrophilic Coating
1. Device Description
The Sentrant™ introducer sheath with hydrophilic coating (Figure 1) is a single-use, disposable, hydrophilic catheter that provides a flexible and hemostatic conduit for the insertion of
endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of 2 components: a dilator and an introducer sheath, which
accommodate a 0.035 in (0.89 mm) guidewire.
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 sheath is comprised of a hydrophilic, coil-reinforced catheter 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 device also has a suture loop for attaching it to
the patient and a strain relief to prevent kinking of the catheter where it joins to the seal housing.
Figure 1. Sentrant Introducer Sheath with Hydrophilic Coating
1. Dilator
2. Dilator grip
3. Tapered tip
4. Introducer sheath
5. Seal housing with hemostatic valve assembly (sheath hub)
6. RO marker band
7. Sideport extension with 3-way valve
8. Suture loop
9. Strain relief
10. 3-way valve handle
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 Sentrant introducer sheath with hydrophilic coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature 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.
Caution: Federal (USA) law restricts this device to sale by or on order of a physician.
Do not alter this device. Alterations may impair device function.
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Do not cut or puncture the catheter. 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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Do not use if the device is damaged.
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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
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integrity of the device or create a risk of contamination of the device, which could result in patient injury, illness, or death.
After use, dispose of the device in accordance with hospital, administrative, or government policies.
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The catheter is only compatible with a 0.89 mm (0.035 in) guidewire.
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Verify the size compatibility of the sheath, device, catheter, and accessory components prior to use. The maximum diameter and length of the instrument or catheter to be
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introduced should be determined to ensure its passage through the sheath.
Note: The working length of the sheath does not include the strain relief feature on the catheter.
If scar tissue is present, predilatation may be required.
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Instructions for Use English 3
Adequate vessel access is required to introduce the sheath into the vasculature. Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification,
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plaque and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal. If the vessel is not adequate for access or the vessel size is smaller than
the introducer sheath's outer diameter, major bleeding, vessel damage, serious injury, or death may result.
When inserting, manipulating, or withdrawing a device through the sheath, always maintain sheath position.
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When inflating a balloon, ensure the balloon is completely outside of the Sentrant device.
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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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Individual patient anatomy and physician technique may require procedural variation.
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5. Adverse Events
5.1. Potential Adverse Events
Adverse events or complications associated with use of the Sentrant introducer sheath include, but are not limited to:
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 Sentrant introducer sheath is individually packaged. It is supplied sterile (ethylene oxide) for single use only.
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 the device; contact a Medtronic representative for return information.
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6.2. Contents
one Sentrant introducer sheath with dilator
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one web reference leaflet
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6.3. Storage
Store the Sentrant introducer sheath 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 Sentrant introducer sheath should only be used by physicians and teams trained in vascular interventional techniques.
7.2. Device Inspection
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
0.035 in (0.89 mm) guidewire
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heparinized saline solution
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8. Instructions for Use
1. Remove the device from the package and ensure that the inner diameter (ID) of the sheath is appropriate for the maximum diameter of the instrument or catheter to be
introduced.
2. Verify that the vessel is of adequate diameter and the tortuosity is not too severe to accommodate the introducer sheath.
3. Prepare the sheath for flushing and ensure that the 3-way valve is open. There are two options to do this. See Figure 2.
Figure 2. 3-way valve in open positions.
4. Remove the cap from the open port on the 3-way valve.
5. Connect a syringe of heparinized saline solution to the open port and flush the sheath (tapping the introducer sheath to aid in releasing air bubbles).
6. Close the 3-way valve. See Figure 3.
4 Instructions for Use English
Figure 3. 3-way valve in closed position
7. Connect a syringe of heparinized saline solution to the Luer fitting on the dilator and flush the dilator.
8. Insert the dilator completely into the introducer sheath and secure it by rotating the dilator grip clockwise, approximately ¼ turn.
9. Follow accepted clinical practice for vessel access and guidewire insertion.
10. 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.
11. Under fluoroscopic guidance, advance the sheath and dilator as a unit over the guidewire to the desired location. Stop advancement if there is resistance and investigate the
cause of the resistance before proceeding.
12. While holding the sheath steady and maintaining guidewire position, unlock and withdraw the dilator from the sheath until the dilator is completely removed from the sheath and
guidewire.
13. While maintaining guidewire position, advance the selected interventional device over the guidewire, through the valve, and into the sheath. Stop advancing the interventional
device if there is resistance and investigate the cause of the resistance before proceeding.
14. Interventional devices can be interchanged as necessary.
15. Upon removal of the sheath, take care to prevent bleeding, vessel damage, or other serious injury. Advancing the dilator into the sheath prior to withdrawing the sheath may ease
withdrawal from the vasculature.
9. Disclaimer of Warranty
ALTHOUGH THE SENTRANT INTRODUCER SHEATH 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. THE WARNINGS CONTAINED IN THE PRODUCT LABELING PROVIDE MORE DETAILED INFORMATION AND ARE CONSIDERED AN INTEGRAL PART OF THIS
DISCLAIMER OF WARRANTY. MEDTRONIC, THEREFORE, DISCLAIMS 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 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.
Instructions for Use English 5
Medtronic, Inc.
*M057826T001*
710 Medtronic Parkway
Minneapolis, MN 55432 USA
www.medtronic.com
Tel. +1 763 514 4000
US Customer Service/Product Inquiries
Tel. 800 961 9055
Fax 800 929 2133
© 2017 Medtronic
M057826T001 Rev. 1A
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