Clinician Use Information - Abbott RX Accunet Manual Del Usuario

CLINICIAN USE INFORMATION

Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications,
side effects and hazards commonly associated with carotid interventional procedures should use this device.
WARNING: Do not use after the "Use By" date specified on the package.
WARNING: The device is intended for single-use only. Do not reuse. Do not resterilize as this can compromise device performance
and increase the risk of cross contamination due to inappropriate reprocessing.
WARNING: Use with fixed (passive) hemostatic valves is not recommended.
Materials Required
• 6F Guiding Sheath or 8F Guiding Catheter (Min. Guiding Catheter / Sheath Size (I.D.) 0.085" / 2.2 mm).
• 10 - 20 cc luer-lock syringe
• Heparinized normal saline (sterile)
• Balloon dilatation catheter (optional)
• ≥ 0.096" (2.44 mm) Rotating Hemostatic Valve (RHV) (optional)
• Acculink (over-the-wire) or RX Acculink Carotid Stent System (optional)
• Doc extension wire (optional)
CAUTION: Confirm the compatibility of the RX Accunet EPS with the interventional devices before actual use.
Filter Basket Size Determination
Filter size selection is based on reference vessel diameter in the area where the filter basket will be expanded. See Table below for filter basket
diameters and recommended reference vessel diameters.
Filter Size
Fully Expanded
4.5 mm
5.5 mm
6.5 mm
7.5 mm
WARNING: Overstretching of the artery may result in rupture and life-threatening bleeding.
Inspection Prior to Use
Inspect the product prior to use. Do not use if the package is open or damaged.
CAUTION: Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the
procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged
guide wire may result in vessel damage and / or inaccurate torque response.
Delivery System Preparation
CAUTION: Do not expose the delivery or recovery systems to organic solvents (e.g. alcohol) as structural integrity and / or function
of the device may be impaired.
1. Hold the dispenser hoop and flushing tool securely in one hand.
2. Loosen the RHV on the flush tool.
3. Fill a 10 cc syringe with heparinized normal saline. Holding the flush tool in an upright position (see Figure 2), attach the syringe as shown,
and flush gently to remove air from the filter. Observe fluid exiting the RHV.
4. Confirm that no part of the light blue, distal section of the delivery sheath is within the RHV, then tighten the RHV onto the delivery sheath.
5. Release the flushing tool and delivery sheath from the dispenser hooks. Release the proximal end of the wire from its dispenser hook. Grasp the
delivery sheath and the flush tool securely together, and remove from the dispenser. Inspect the delivery system for kinks, or other damage.
6. Flush to remove air from the sheath. Observe fluid exiting the proximal end of the delivery sheath.
7. Place the torque device onto the proximal end of the RX Accunet EPS guide wire and tighten.
8. While observing through the flushing tool, pull the filter basket back into the delivery sheath (by pulling proximally on the torque device) until
the distal tip of the delivery sheath aligns with the proximal end of the blue filter obturator (see Figures 3 and 4). DO NOT pull the torque
device such that the proximal end of the blue filter obturator goes into the distal tip of the delivery sheath. Doing so will cause a reduction in
device flexibility and deliverability, and has the potential to damage (crumple) the delivery sheath and adversely affect filter basket delivery.
Note: Step 8 may be repeated a maximum of two additional times.
9. Loosen the RHV of the flushing tool, and slide the flushing tool off the distal end of the delivery system.
10. Loosen the torque device and position it so that the light blue, proximal end of the delivery sheath is within the central collet tube of the peel
away adapter of the torque device. Tighten the torque device to the wire.
EL2069693 (2015-07-31)
Page 3 of 53
RELEASED RELEASED
Reference Vessel Diameter
Minimum to Maximum Range
3.25 to 4.0 mm
4.0 to 5.0 mm
5.0 to 6.0 mm
6.0 to 7.0 mm
Printed on : 01/21/2016
Flushing Tool
Figure 2
Flush air from filter
Filter Basket
PROPER Alignment of Delivery Sheath
IMPROPER Alignment - Too Far
Align distal tip of delivery sheath with proximal end of obturator (blue)
Recovery Catheter Preparation (for both the RX Accunet Recovery Catheter and the RX Accunet 2 Recovery Catheter)
1. Choose one of the two recovery catheters provided, based on the relevant features of the device and how those features may best address the
conditions of the case (e.g., CCA / ICA tortuosity, protruding stent struts, difficulty of aortic access). The RX Accunet Recovery Catheter – " Shape-
able Tip Design" has a shapeable tip that is designed to provide torqueability or steerability at the tip of the device. The RX Accunet 2 Recovery
Catheter – "Low-Profile, Flexible Design" is more flexible than the RX Accunet Recovery Catheter and has an extended soft tip and lower profile
designed to deflect away from stent struts.
2. Remove the selected recovery catheter from the dispenser hoop.
3. Fill a 10 cc syringe with heparinized normal saline.
4. Flush the selected recovery catheter to remove air using one of two methods:
• Align the tip of the syringe with the distal tip of the recovery catheter and flush to remove air, or
• Use the flushing tool from the RX Accunet EPS delivery system: Attach a luer lock syringe to the distal end of the flushing tool, and insert
the distal 3 cm of the recovery catheter into the proximal end of the flushing tool. Lightly close the RHV of the flushing tool, and flush
gently to remove air from the recovery catheter. Do not close the RHV on the clear tip area of the recovery catheter. Observe fluid exiting
the exit notch.
5. If using the RX Accunet Recovery Catheter – "Shapeable-Tip Design", the distal 3 cm of the catheter may be shaped as needed to allow for tip
deflection.
General guidelines for shaping the RX Accunet Recovery Catheter:
• Keep the shaping ribbon on the outside of the curve
• Place the bend at the proximal part of the shaping ribbon. This section is the area where the orange catheter body transitions to the clear
tip area.
Guiding Catheter / Sheath Support
Introduce guiding catheter / sheath into vasculature and confirm that it is well positioned and firmly seated prior to introduction of the
RX Accunet EPS. Always maintain view of the tip of the guiding catheter / sheath to minimize the likelihood of the catheter backing out or
prolapsing into the aortic arch.
WARNING: Maintain proper guiding catheter / sheath support in the common carotid artery throughout the procedure.
If guiding catheter / sheath access cannot be maintained, the case should be discontinued. Failure to maintain proper support of
the guiding catheter / sheath can lead to prolapse of the catheter into the aortic arch, resulting in any of the following:
• Movement of an open filter through an undilated lesion;
• Filter-stent entanglement, filter basket detachment and / or proximal movement of the stent; or
• Filter guide wire breakage
Lesion Preparation
WARNING: Maintain the patient's ACT at > 250 seconds throughout RX Accunet EPS usage to prevent thrombus formation on the
device.
CAUTION: Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either
pharmaceutical intervention or placement of a temporary pacemaker, if needed.
If desired, a 2 mm balloon may be used to predilate the lesion.
Delivery Procedure
CAUTION: Observe all guide wire movement in the vessels using fluoroscopic guidance.
CAUTION: The delivery system is not designed for use with power injection. Use of power injection may adversely affect device
performance.
CAUTION: Do not deliver the RX Accunet EPS guide wire with filter basket through any interventional devices other than the RX
Accunet EPS delivery system.
WARNING: Use with fixed (passive) hemostatic valves is not recommended.
1. Use standard percutaneous techniques. Shape the tip of the RX Accunet EPS guide wire, if desired.
2. Carefully insert the guide wire tip of the delivery system into the funnel of the introducer tool and advance the unit completely into the RHV
until the delivery sheath has entered the guiding catheter / sheath. Remove the introducer tool.
CAUTION: To avoid air entrapment, do not leave the introducer tool in the valve while advancing the delivery system. Advance
the delivery system slowly through the guiding catheter / sheath.
Note: If using a long sheath with a hemostasis valve, the introducer tool should not be peeled off. Rather, it should be pulled back onto the
sheath so that it can be reinserted later to facilitate deployment.
3. Under fluoroscopy, advance the tip of the delivery system into the selected vessel and across the lesion using the torque device to steer the
guide wire. Do not torque the delivery sheath.
Delivery Sheath
Distal Tip
Filter Basket Filter Basket
Flushing Tool
Syringe
Syringe
Figure 3
Retract filter into sheath
Blue Obturator
Proximal End Distal End
Figure 4