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Instructions for Use
Riptide™ Aspiration System
DEVICE DESCRIPTION
The Riptide™ Aspiration System is comprised of the following devices:
•
React™ 68 Catheter
•
React™ 71 Catheter
•
Riptide™ Large Bore Aspiration Tubing
•
Riptide™ Aspiration Pump
•
Riptide™ Collection Canister with Intermediate Tubing
The Riptide™ Aspiration System is designed to remove occlusive thrombus from the cerebral
vasculature using continuous aspiration. The catheter shaft has a hydrophilic coating that
spans the distal 40 cm to reduce friction during use. The catheter acts as a conduit for
providing direct aspiration to the occlusion site generated by the Riptide™ Aspiration Pump.
The catheter is introduced through a guide catheter or sheath and into the intracranial
vasculature and guided over a neurovascular guidewire and/or microcatheter to the site of
the primary occlusion. The catheter is connected to the Riptide™ Aspiration Pump through the
aspiration tubing. The Intermediate Tubing connects the Riptide™ Collection Canister to the
Riptide™ Aspiration Pump. The Riptide™ Aspiration System in this configuration may be used
to aspirate thrombus from the occluded vessel.
Note: The catheter and aspiration tubing are Applied Parts.
INTENDED PURPOSE / INDICATIONS FOR USE
The Riptide™ Aspiration System is intended for use in the revascularization of patients with
acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the
internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within
8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen
activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
CONTRAINDICATION
There are no known contraindications.
WARNINGS
•
The Riptide™ Aspiration System should only be used by physicians who have
received appropriate training in interventional neuro-endovascular techniques for
treatment of acute ischemic stroke. The Riptide™ Aspiration System is designed for
setup by clinical support staff under the supervision of a trained physician.
•
Do not advance, retrieve, or use any component of the Riptide™ Aspiration System
against resistance without careful assessment of the cause using fluoroscopy.
If the cause cannot be determined, withdraw the device or system as a unit.
Unrestrained torquing or forced insertion of the catheter against resistance may
result in damage to the device or vessel.
•
For vessel safety, do not perform more than three attempts at aspiration in the
same vessel using the Riptide™ Aspiration System.
•
Do not use devices in conjunction with or in place of those devices specified above
when using the Riptide™ Aspiration System.
PRECAUTIONS
•
The catheter and the aspiration tubing are supplied sterile and are intended for
single use only. Do not resterilize or re-use. Resterilization and/or re-use may result
in ineffective catheter coating lubrication, which may result in high friction and the
inability to access the target neuro vasculature location.
•
Use the catheter, aspiration tubing, and Riptide™ Collection Canister with Intermediate
Tubing prior to the "Use-by date".
•
The Riptide™ Aspiration Pump and Riptide™ Collection Canister with Intermediate
Tubing are supplied non-sterile and are intended for use outside of the sterile field
only.
•
The Riptide™ Collection Canister with Intermediate Tubing is intended for single use
only. Dispose in accordance with standard biologic waste disposal procedures.
•
Do not use kinked or damaged devices. Do not use open or damaged packages.
•
Inspect the catheter before use to verify that its size and condition are suitable for the
specific procedure.
•
Use the catheter under fluoroscopic guidance to confirm placement of the catheter
proximal to the thrombus prior to applying aspiration.
•
Maintain a constant infusion of appropriate flush solution.
•
When performing aspiration, ensure that the aspiration tubing flow switch is in the
open position for only the minimum time needed to remove thrombus.
•
The recommended continuous duration of aspiration is a maximum of 90 seconds.
•
If repositioning of the catheter is necessary during the revascularization procedure,
such reposition should be performed over an appropriate neurovascular guidewire
and/or microcatheter using standard techniques.
•
Do not use automated high-pressure contrast injection equipment with the catheter
because it may damage the device.
•
Medical management and post stroke care should follow AHA/ASA guidelines and
institutional protocols.
•
As in all surgical interventions, monitoring of intra-procedural blood loss is
recommended so that appropriate management may be instituted.
•
Possible malfunctions of the Riptide™ Aspiration System include, but are not limited
to, issues associated with vacuum for the aspiration tubing, Riptide™ Aspiration Pump,
and Riptide™ Collection Canister with Intermediate Tubing that may lead to decreased
en
therapeutic response during mechanical thrombectomy.
•
Operators should take all necessary precautions to limit X-radiation doses to patients
and themselves by using sufficient shielding, reducing fluoroscopy times, and
modifying X-ray technical factors where possible.
POTENTIAL ADVERSE EVENTS
•
acute occlusion
•
allergic reaction and anaphylaxis
from contrast media
•
arrhythmia
•
complication at puncture site
•
complication of radiation exposure
REACT-68
(e.g., alopecia, burns ranging in
REACT-71
severity from skin reddening to
MAT-110-110
ulcers, cataracts, and delayed
neoplasia)
MAP-1000EU
•
death
MAC-1200
•
decreased therapeutic response
•
embolism
•
fistula
PROCEDURE
1.
Refer to Warnings, Precautions, and Potential Adverse Events prior to use.
2.
As each component of the Riptide™ Aspiration System is used, remove the component
from the packaging and inspect for damage or for kinks.
3.
Prepare a guide catheter or sheath according to the device manufacturer's Instructions
for Use.
4.
Place the guide catheter or sheath into the appropriate artery for access to the
occlusion site.
CATHETER PREPARATION AND USE
1.
Confirm vessel diameter and ensure the catheter is appropriate for treatment of the
vessel.
Model
REACT-68
REACT-71
2.
Prepare the catheter for use by flushing the packaging hoop and device with
heparinized saline.
3.
Remove the catheter from the packaging hoop.
4.
Inspect the catheter for kinks or damage. If any damage is observed, replace with a
new device.
NOTE: When using the React™ 71 Catheter, the minimum inner diameter
recommended for a sheath is 0.087" (2.21 mm).
5.
Connect a rotating hemostasis valve to the proximal hub of a guide catheter or sheath.
6.
Insert the catheter through the rotating hemostasis valve. If required, the provided
split y-introducer may be used to facilitate the introduction of the catheter through
the rotating hemostasis valve, inserting the tip through the introducer starting at the
split end and penetrating the valve with the tubular introducer end. After the catheter
has passed through the rotating hemostasis valve, the split y-introducer may be
removed by backing it out of the valve, pulling gently on the split ends to separate the
remaining portion. Discard the separated introducer.
7.
Using conventional catheterization techniques under fluoroscopic guidance advance
the catheter into the target vessel over an appropriate neurovascular guidewire and/or
microcatheter. Position the catheter proximal to the thrombus. Remove the guidewire
and/or microcatheter from the catheter.
NOTE: Access to the site of occlusion may be aided by the triaxial use of a compatible
inner microcatheter.
Riptide™ Aspiration
Pump
Figure 1: Riptide™ Aspiration System Setup Diagram
Riptide™ Aspiration System PREPARATION AND
USE
1.
Refer to Figure 1 (above) for the correct arrangement of devices for proper setup of
the Riptide™ Aspiration System.
2.
Refer to the Riptide™ Aspiration Pump User's Manual for pump setup, operating
instructions and troubleshooting if required.
3.
Refer to the Riptide™ Collection Canister Quick Reference Guide for assembly setup.
•
foreign body in patient
•
hypertension/hypotension
•
infection
•
inflammation
•
intracranial hemorrhage
•
ischemia
•
nerve damage
•
neurological deficits including
stroke
•
organ failure/shock
•
pain
•
stenosis
•
vessel spasm, thrombosis,
dissection, or perforation
Recommended Sizing Guidelines
Recommended Vessel Diameter (mm)
Minimum
≥2.7
≥2.7
Riptide™ Collection Canister
with Intermediate Tubing
Aspiration Tubing
Catheter
3
4.
Place the Riptide™ Aspiration Pump on a stable, flat horizontal surface outside of the
sterile field within reach of the aspiration tubing and providing sufficient slack to the
patient table. Locate the Riptide™ Aspiration Pump such that a minimum of 6 inches
(approximately 15 cm) clearance exists in all directions to adjacent objects or other
common cath lab equipment, powered or un-powered.
5.
Attach the Riptide™ Aspiration Pump's power cord to the designated mains power
specified in the Riptide™ Aspiration Pump User's Manual. Confirm that the power
cord is securely plugged into the back of the pump enclosure. If required, attach the
potential equalization connector to the potential equalization plug.
6.
The Riptide™ Collection Canister lid should be pre-assembled to the cup as it is
removed from its packaging. If it is not or becomes separated, secure the lid to the cup
by snapping it tightly on the lip.
7.
The large drain port on the Riptide™ Collection Canister lid should be pre-assembled
with a closure cap as it is removed from its packaging. If it is not or becomes separated,
seal the port with the large tethered cap on the lid by pressing it in place firmly. The
small caps attached to the lid may remain tethered and unused until needed.
8.
Place the Riptide™ Collection Canister into the receptacle on the Riptide™ Aspiration
Pump and press firmly into place. The horizontal port marked with the embossed
label as labeled "PATIENT" should point away from the pump enclosure to enable
unobstructed attachment of the aspiration tubing.
9.
The Intermediate Tubing should be pre-assembled to the Riptide™ Collection Canister
lid as it is removed from its packaging. If it is not or becomes separated, secure the
connector at one end of the supplied Intermediate Tubing over the vertical central port
of the Riptide™ Collection Canister marked with the embossed label as "VACUUM" by
pressing down firmly. Either connector end of the Intermediate Tubing may be used.
10.
Attach other end of the Intermediate Tubing to the vacuum inlet of the Riptide™
Aspiration Pump by pressing down firmly.
11.
Open the aspiration tubing pouch with the contents accessible toward the sterile field.
Remove the tubing assembly from the pouch into the sterile field direction. Place
or hold the distal end with the flow control switch on the patient table and pass the
proximal end of aspiration tubing from the sterile field to the Riptide™ Collection
Canister located on the Riptide™ Aspiration Pump.
12.
Attach the connector at the proximal end of the aspiration tubing to the horizontal
Riptide™ Collection Canister port marked with the embossed label as labeled
"PATIENT". Press the connector firmly onto the port.
13.
Slide the actuator of the flow control switch on the aspiration tubing to OFF to close
the tubing to flow.
14.
Press the start button on the Riptide™ Aspiration Pump and allow it to run for at least
one minute. Confirm normal operation and the presence of vacuum as indicated on
the gauge.
15.
Using the vacuum control knob on the Riptide™ Aspiration Pump, adjust the vacuum
to a reading of minimum 20 inHg (68 kPa) on the gauge but not exceeding 25 inHg
(85 kPa). Adjust the vacuum by rotating the vacuum control knob until the gauge
reads the desired vacuum level. To increase the vacuum, turn the knob clockwise. To
decrease the vacuum, turn the knob counter-clockwise.
Note: It is normal for the indicator needle of the gauge to oscillate or vibrate in
response to pump pulsation. Allow the range of the needle to stabilize and adjust the
vacuum control so that the midpoint of the motion aligns with the desired setting.
16.
The Riptide™ Aspiration System is now ready to aspirate.
17.
Connect luer fitting at the distal end of the aspiration tubing to the side port of the
rotating hemostasis valve attached to the catheter.
18.
Advance the distal tip of the catheter to engage with the proximal end of the
thrombus or in accordance with the physicians preferred technique.
19.
To begin aspiration, slide the flow control switch toward the ON position. To stop the
aspiration flow, slide the actuator of the flow control switch toward the OFF position.
20.
If necessary, additional passes with catheter may be used to further remove thrombus
at the discretion of the physician.
21.
After withdrawal from the patient, disconnect the aspiration tubing from the catheter;
replace it with 5cc or 10cc syringe, and aspirate approximately 5cc of blood from the
catheter to remove any thrombus that may remain.
22.
Obtain a post-treatment angiogram in accordance with the physicians preferred
technique.
23.
At the conclusion of the aspiration procedure, turn OFF the Riptide™ Aspiration
Pump. The catheter, the aspiration tubing, and the Riptide™ Collection Canister with
Intermediate Tubing are single use. Remove and discard in accordance with standard
biological waste disposal procedures.
24.
Clean and prepare the Riptide™ Aspiration Pump for storage as described in the
User's Manual.
WARRANTY DISCLAIMER
Although this product has been manufactured under carefully controlled conditions, the
manufacturer has no control over the conditions under which this product is used. The
manufacturer 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. The manufacturer 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 the manufacturer
to any representation or warranty with respect to the product. The exclusions and limitation
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 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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