Claret Medical Sentinel Cerebral Protection System Instrucciones De Uso

TM
Claret Medical
Sentinel TM Cerebral Protection System
Only
Instructions for Use
PRODUCT DESCRIPTION
The Claret Medical Sentinel Cerebral Protection System is a percutaneously delivered embolic protection device, designed to capture and remove
debris dislodged during endovascular procedures. The Sentinel System utilizes an embolic filter delivered to the brachiocephalic artery (Proximal Filter),
and a second embolic filter delivered to the left common carotid artery (Distal Filter). At the completion of the procedure, the filters and debris are
recaptured into the catheter and removed from the patient.
The Sentinel System consists of a 6 French catheter with deployable Proximal and Distal Filters, an Articulating Sheath and an integral handle assembly.
The Articulating Sheath tip, Proximal Sheath tip, Proximal Filter hoop, Distal Filter hoop and Distal Filter tip are radiopaque to enable visualization during
use. See Figures 1 and 2.
Table 1: Filter-Vessel Sizing Guide
REF (Model) Proximal Target Proximal
Number for Filter Size Vessel Size
Ordering (mm) (mm)
CMS15-7A
CMS15-7B
CMS15-7C
9.0 – 15.0
15
CMS15-10A
CMS15-10B
CMS15-10C
Table 2: Sentinel System Specifications
Delivery Profile 6F
Working Length 95 cm
Articulating Sheath Length 4 cm
0.014" (0.36 mm) diameter floppy tip coronary guidewire, 175 cm minimum length
Guidewire Compatibility
Package contains one (1) Sentinel System*
*Reference package label for specific model. Review patient anatomy by CT or angiogram prior to selecting appropriate curve shape per Figure 3.
INDICATIONS FOR USE
The Sentinel System is indicated for use as an embolic protection device to capture and remove embolic material (thrombus/debris) that may enter the
cerebral vascular system during endovascular procedures. The diameters of the arteries at the sites of filter placement should be measured and the filters
sized to the Proximal and Distal Target Vessels as listed in Table 1.
CONTRAINDICATIONS FOR USE
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Do not use with patients in whom anticoagulant and antiplatelet therapy is contraindicated.
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Do not use in vessels with excessive tortuosity.
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Do not use in patients with uncorrected bleeding disorders.
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Do not use this product on patients with compromised blood flow to the right upper extremity.
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Do not use in a patient who has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
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Do not use in a patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic
ostium or within 3 cm of the aortic ostium.
WARNINGS
The Sentinel System should only be used by physicians who have received appropriate training and are familiar with the principles, clinical applications,
complications, side effects, and hazards commonly associated with endovascular procedures.
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Carefully read all instructions and labeling prior to use. Observe all warnings, cautions, and precautions noted throughout these instructions. Failure
to do so may result in complications.
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Refer to the instructions for use supplied with any interventional device to be used in conjunction with the Sentinel System for their intended uses,
sizing, warnings, and precautions.
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The appropriate antiplatelet/anticoagulation therapy should be administered pre- and post-procedure in accordance with standard medical practice.
•
Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product from a damaged package.
•
Never advance or withdraw the Sentinel System without proper fluoroscopic guidance or against resistance until the cause is determined.
Advancing with such resistance may lead to embolization of debris, and vessel and/or device damage.
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It is recommended that the patency of the right radial or brachial artery be assessed prior to the introduction of the Sentinel System.
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It is recommended that the patient be administered an Allen Test should the radial artery be used for device introduction.
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Do not use the device in left radial or left brachial access.
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Do not use the Sentinel System to deliver any type of fluid to the patient e.g. contrast media, heparinized saline, etc. due to risk of air embolization
or comprise to device performance.
•
Minimize movement of the Sentinel System after initial placement. Excessive movement of filters may lead to embolization of debris, vessel and/or
device damage.
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Do not deploy the filters within a previously repaired artery.
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Observe the Sentinel System under fluoroscopy and monitor the patient to verify the filters have not become occluded with debris resulting in slow
or no flow. The filters should be recovered if they become occluded or if flow is compromised (See Procedural Use – Retrieval).
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Indwell time of the Sentinel System is not to exceed 90 minutes. Occlusion could occur, resulting in slow or no flow.
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Failure to adequately close off the Flush Ports (Front Handle, Rear Handle) may result in air embolism.
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Do not undersize or oversize the filters in relation to the selected vessel diameter. This may result in inadequate vessel wall apposition or incomplete
deployment of the filters. (Refer to Sizing Guide, Table 1).
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Do not apply excessive force to the Sentinel System. This may lead to distal embolization of debris, and vessel and or device damage.
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Contents supplied STERILE using a radiation process. Do not use if sterile barrier is damaged. If damage is found, call your Claret Medical
representative.
Page 1 of 30
CONFIDENTIAL—CLARET MEDICAL, INC.
Distal Filter Target Distal Articulating
Size Vessel Size Sheath Curve
(mm) (mm) Shape
A
5.0 – 7.0
7 B
C
A
6.5 – 10.0
10 B
C
•
For single patient use only. Do not reuse, reprocess, or re-sterilize as these may compromise the structural integrity of the device and/or lead to
device failure, and may result in patient injury, illness, or death. Reuse, reprocessing, or re-sterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness, or death of the patient.
•
After use, dispose of product and packaging in accordance with hospital, administrative, and/or local government policy.
PRECAUTIONS
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Do not forcefully bend or reshape the Articulating Sheath of the Sentinel System. This may cause device damage.
•
Do not use the product if the packaging sterile barrier has been damaged or compromised.
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Improper bending of the Sentinel System may damage the catheter.
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Do not re-sterilize or reuse on another vessel or patient.
POTENTIAL COMPLICATIONS
Access Site Complication/Injury, Angina, Bleeding, Death, Dissection, Embolism, Emergent Surgery, Hematoma, Ischemia, Infection, Myocardial
Infarction, Renal Insufficiency, Stroke, and Vessel Injury.
INSTRUCTIONS FOR USE
Preparing the Sentinel System for Use
1. Administer anticoagulation medications and monitor activated clotting time per standard institutional guidelines. Anticoagulant therapy
sufficient to maintain an Activated Clotting Time of at least 250 seconds for the duration of the procedure is recommended.
2. Perform angiogram of the aortic arch.
3. Identify the location within the vessels where the filters will be deployed. Measure the vessel diameter at these locations in millimeters and
select the appropriate Sentinel System Proximal and Distal Filter diameter.
WARNING: Do not undersize or oversize the filters in relation to the selected vessel diameter. This may result in inadequate vessel wall
apposition, incomplete deployment of the filters, or vessel damage.
4. Ensure the introducer sheath size will accommodate the Sentinel System.
5. Using sterile techniques remove the Sentinel System from the packaging and place in a sterile work area.
CAUTION: Do not use the product if the packaging sterile barriers have been damaged or compromised.
WARNING: Inspect the device for any damage. Never use damaged product or product from a damaged package.
Flushing the Sentinel System
CAUTION: Do not prepare the Sentinel System or sheath the Proximal and Distal Filters until immediately prior to use.
Note: The device handle has two handle locks, the Rear Handle Lock, and the Front Handle Lock. Refer to Figure 1. Closing these locks
facilitates flushing, prevents back-bleeding, and prevents motion of the device handle components and Distal Filter. The locks should be
temporarily opened to facilitate movement of the handle components as required.
Note: The primary controls used to deploy the device, the Proximal Filter Slider (#1), the Articulation Knob (#2), and the Distal Filter Slider
(#3), are all marked with the number "1", "2" and "3" indicating the order in which they are used. In this document, these names will be
shown with the control number appended to the name.
1. Remove the packaging stylet from the distal guidewire lumen and discard.
2. Ensure that both the Front Handle Lock and the Rear Handle Lock are tightened.
3. Flush through the Flush Port in the Distal Filter Slider (#3) with heparinized saline until all air is removed and fluid passes from Distal Filter
Tip guidewire lumen. See Figure 1.
4. Flush through the Rear Handle Flush Port with heparinized saline until all air is removed and fluid passes from the tip of the Articulating
Sheath. See Figure 1. Ensure that the flush port stopcock is closed following flushing.
5. Flush through the Front Handle Flush Port with heparinized saline until all air is removed and fluid passes from the tip of the Proximal
Sheath. See Figure 1. Ensure that the flush port stopcock is closed following flushing.
6. Submerge the distal end of the device in heparinized saline, and loosen the Rear Handle Lock. With the distal tip submerged, slowly
retract the Distal Filter by pulling back on the Distal Filter Slider (#3) until the filter is fully collapsed into the Articulating Sheath. The
submerged filter may be agitated during sheathing in order to facilitate removal of bubbles. Tighten the Rear Handle Lock.
Note: Flushing and sheathing of the Distal Filter may be repeated to ensure all air has been removed from the system.
CAUTION: Do not over-retract the Distal Filter as damage may occur.
7. Ensure the Articulating Sheath is fully advanced until the Articulation Knob (#2) is in contact with the Front Handle Lock to ensure it does
not interfere with sheathing the Proximal Filter. Tighten the Front Handle Lock. While submerged, sheath the Proximal Filter by slowly
advancing the Proximal Filter Slider (#1) relative to the Front Handle until the Proximal Filter is fully sheathed. The submerged filter may
be agitated during sheathing in order to facilitate removal of bubbles. See Figures 1 and 9.
Note: Flushing and sheathing of the Proximal Filter may be repeated to ensure all air has been removed from the system.
8. While submerged, again flush through the Front Handle Flush Port with heparinized saline until all air is removed and fluid passes from the
tip of the Proximal Sheath. See Figure 1. Ensure that the flush port stopcock is closed following flushing.
WARNING: Do not use a Sentinel System that has not been properly flushed. Failure to prepare and flush the device before use may
introduce air and patient injury may result.
Note: Tighten both the Rear and Front Handle Locks prior to delivering device to prevent inadvertent movement.
Note: Use a minimum of 10 cc of heparinized saline to flush through the Front Handle Flush Port to ensure all air has been removed from
the system.
Note: Refer to the instructions for use supplied with any interventional device to be used in conjunction with the Sentinel System for their
intended uses, sizing, warnings, and precautions.
Procedural Use - Delivery and Deployment
WARNING: Do not use a Sentinel System that has not been properly flushed. Failure to prep and flush the device before use may
introduce air and patient injury may result.
PL-10600-02 Rev H
DCR# 2370 4/16/2018