Medtronic REACT-71 Instructions for Use
Catheter
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Cathéter
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Catéter
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Cateter
M994065ADOC2 Rev. A (04/2019)
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Instructions for Use
React™ Catheter
DEVICE DESCRIPTION
The catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a
hydrophilic coating that spans the distal 40 cm to reduce friction during use. The catheter shaft is visible
under fluoroscopy. The catheter dimensions are included on the individual device label. The catheter is
introduced through a guide catheter or sheath and into the intracranial vasculature and guided over a
neurovascular guidewire and/or microcatheter. The proximal end of the catheter has a luer fitting to allow
attachment of accessories and infusion of liquids through the system. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
INDICATIONS FOR USE
The React™ 68 Catheter and React™ 71 Catheter are indicated for the introduction of interventional devices
into the peripheral and neuro vasculature.
CONTRAINDICATIONS
There are no known contraindications.
COMPATIBILITY
Refer to product label for device dimensions. Refer to labeling provided with other medical technologies to
determine compatibility.
WARNINGS
- The catheter should only be used by physicians who have received appropriate training in
interventional techniques.
- Do not reuse. The device is intended for single use only. Discard the catheter after one procedure.
Structural integrity and/or function may be impaired through reuse or cleaning. Catheters are
extremely difficult to clean after exposure to biological materials and may cause adverse patient
reactions if reused.
- The catheter has not been tested for use with automated high-pressure contrast injection equipment,
do not use this equipment with the device because it may damage the device.
RECOMMENDED PREPARATION AND USE
1. Flush package hoop with saline before removing catheter.
2. Gently remove the catheter and packaging hoop from the pouch by grasping the packaging hoop and
slowly pulling the catheter and hoop out of the pouch.
3. Remove the catheter from the packaging hoop.
4. Inspect the catheter for kinks or other damage. If any damage is observed, replace with new device.
5. Connect a rotating hemostasis valve (RHV) to the hub of the catheter and flush the inner lumen with
heparinized saline.
6. Introduce the catheter into the vasculature through the sheath, and over a guide wire using a
percutaneous entry technique of choice. A split sheath is provided in the packaging to provide support
and facilitate the introduction of the tip of the catheter into the sheath.
NOTE: The maximum diameter recommended for a guide wire is 0.038” (0.97 mm). When using the
React™ 71 Catheter, the minimum inner diameter recommended for a sheath is 0.087” (2.21 mm).
7. Under fluoroscopic guidance, advance the system over the guide wire until the desired position is
attained.
8. Remove the guide wire prior to the introduction of other intravascular devices.
STORAGE
Store in a cool, dry and dark place. See the product label for the device “Use-by date.” Do not use the device
beyond its labeled “Use-by date”.
LIMITED WARRANTY
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.
PRECAUTIONS
• Do not use open, kinked, or damaged devices.
• Do not autoclave.
• Use the catheter in conjunction with fluoroscopic visualization.
• Inspect the catheter before use to verify that its size and condition are suitable for the specific
procedure.
• Do not advance or withdraw the catheter against resistance without careful assessment of the cause
using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torqueing the
device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of appropriate flush solution.
• If flow through the catheter becomes restricted, do not attempt to clear the lumen by infusion.
Remove and replace the device.
• Extreme care must be taken to avoid damage to the vasculature through which the catheter passes.
The catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
• Torqueing the catheter may cause damage which could result in kinking and possible separation along
the catheter shaft. Should the catheter become severely kinked, withdraw the catheter.
• An appropriate anticoagulation therapy should be applied per institutional guidelines.
• 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
Possible complications include, but are not limited to, the following:
• acute occlusion
• allergic reaction and anaphylaxis from contrast
media
• complication at puncture site
• complication of radiation exposure (e.g.,
alopecia, burns ranging in severity from skin
reddening to ulcers, cataracts, and delayed
neoplasia)
• embolism
• false aneurysm formation
• infection
• inflammation
• intracranial hemorrhage
• ischemia
• neurological deficits including stroke
• vessel spasm, thrombosis, dissection or
perforation
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