Medtronic 106F-071-95 Instructions for Use
Rist™
071 Radial Access Guide Catheter
fr
Cathéter-guide à accès radial071
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Instructions for Use
Rist™071 Radial Access Guide Catheter
CAUTION
• Federal (USA) Law restricts this device to sale, distribution, and use by or on the order of a physician.
• This device should be used only by physicians with a thorough understanding of angiography and
percutaneous interventional procedures.
DESCRIPTION
The Rist™071 Radial Access Guide Catheter is a single lumen, exible, variable stiness guide catheter. It
has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The Rist™071 Radial
Access Guide Catheter shaft has a 25cm lubricious coating at the distal end to reduce friction during use.
Each package includes one Rist™071 Radial Access Guide Catheter and one Dilator. Dimensions of the
Rist™071 Radial Access Guide Catheter are included on the individual device label.
DEVICE COMPATIBILITY
The inner lumen of the Rist™071 Radial Access Guide Catheter is compatible with 5.5F (0.070inch or
1.78mm Outer Diameter) or smaller catheters. The Rist™071 Radial Access Guide Catheter is compatible
with radial short sheaths with an Inner Diameter of 6F (0.087inch or 2.21mm) or greater.
INTENDED PURPOSE / INDICATIONS FOR USE
The Rist™071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into
the peripheral, coronary, and neuro vasculature.
CONTRAINDICATIONS
The Rist™071 Radial Access Guide Catheter is contraindicated for use with liquid embolic agents, such as
n-butyl cyanoacrylate, ethylene vinyl alcohol, and dimethyl sulfoxide (DMSO) based materials.
PREPARATION FOR USE
1. Select the appropriately sized device based on procedure type and patient anatomy.
2. Grasp the hub and gently remove the Rist™071 Radial Access Guide Catheter Guide from its protective
tubing.
3. Inspect the product for kinks or other damage. If any damage is observed, replace with a new device.
4. Flush the inner lumen and outer surface with saline and connect a Hemostasis valve to the hub of the
Rist™071 Radial Access Guide Catheter.
IF USING DILATOR:
• Flush and wet the dilator with saline.
• Insert the dilator completely into the Rist™071 Radial Access Guide Catheter.
DIRECTIONS FOR USE
1. Gain primary radial artery access using standard technique.
IF NOT USING A SHORT SHEATH:
• Advance the Rist™071 Radial Access Guide Catheter /dilator assembly over the guide wire
(0.038inches or smaller) and advance products into vasculature. Remove the dilator.
IF USING A SHORT SHEATH:
• Advance the Rist™071 Radial Access Guide Catheter over the guide wire into the short sheath. It is
recommended to use a shaped catheter/dilator with the Rist™071 Radial Access Guide Catheter to
aid insertion into a short sheath.
• Insert appropriately sized catheters as needed and advance products to the intended vascular site
under uoroscopic guidance.
2. When use of the Rist™071 Radial Access Guide Catheter is complete, remove the product using
standard technique.
3. After use, the device may be a potential biohazard. Handle and dispose of product in accordance with
facility protocol and applicable local, state, and federal laws and regulations.
• When the Guide Catheter is introduced to the vascular system, it should be manipulated while
under high- quality uoroscopic observation. Do not advance or retract the Guide Catheter if
resistance is met during manipulation; determine the cause of the resistance before proceeding.
• Torquing or moving the device against resistance may result in damage to the vessel or device.
• This device is coated with a hydrophilic coating at the distal end of the device for a length of 25cm.
Please refer to the Preparation for Use for further information on how to prepare and use this device
to ensure it performs as intended. Failure to abide by the warnings in this Instructions for Use may
result in damage to the device coating, which may necessitate intervention or result in serious
adverse events.
PRECAUTIONS
• Use the device prior to the “Use By” date specied on the package.
• Maintain a constant infusion of appropriate ush solution.
• If ow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove
and replace the device.
• Examine the device to verify functionality and to ensure that its size and shape are suitable for the
specic procedure for which it is to be used.
• This device should be used only by physicians with a thorough understanding of angiography and
percutaneous interventional procedures.
• Prior to beginning radial artery access, conduct screening, such as an Allen test, to ensure that radial
access is appropriate for the patient.
• For other devices and uids not supplied within this package but used in conjunction with this product,
please refer to their respective Instructions for Use.
• Operators should take all necessary precautions to limit X-ray radiation doses to patients and
themselves by using sucient shielding, reducing uoroscopy times, and modifying X-ray technical
factors whenever possible.
• Avoid wiping the device with dry gauze as this may damage the device coating.
• Avoid excessive wiping of the coated device.
• Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may
cause unpredictable changes in the coating which could aect the device safety and performance.
• Use an appropriate hemostasis valve during the procedure.
POTENTIAL COMPLICATIONS
Potential complications of the device and the endovascular procedure include or are synonymous with, but
may not be limited to:
• Access site complications, including sterile
inammation or granulomas
• Air Embolism
• Allergic Reaction, including anaphylaxis from
contrast media and contrast media related risks
(e.g., kidney damage)
• Death
• Embolism
• False Aneurysm Formation
• Fistula
• Hemorrhage
• Hypersensitivity
• Hypotension
• Infection
• Inammation
• Intracranial hemorrhage
• Ischemia
• Material Left in Patient
• Neurological decit/ dysfunction
• Occlusion
• Organ failure
• Pain And Tenderness
• Pathological Hand Cold Intolerance
• Radial Artery Occlusion
• Stenosis
• Stroke/ Cerebral infarction
• Therapeutic response decreased
• Thromboembolism
• Thrombus/ Thrombosis
• Vessel Collapse
• Vessel Dissection
• Vessel Perforation or Rupture
• Vessel Spasm/ Vasoconstriction
• Vision symptoms
• Hand Dysfunction
• Complications of radiation exposure such as
alopecia, burns ranging in severity from skin
reddening to ulcers, cataracts, and delayed
neoplasia
• Tissue necrosis
WARNINGS
• Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do
not use the device if breaches in the sterile barrier system integrity are evident.
• Carefully inspect the device packaging prior to use. Do not use if package appears open or damaged
or if any of its components is missing. If damage is found, call your Medtronic representative.
• This device is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization
may also create a risk of contamination of the device and/or cause patient infection or crossinfection, 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.
HOW SUPPLIED
This device is supplied STERILE using ethylene oxide. This device is non-pyrogenic.
STORAGE AND DISPOSAL
• This device should be stored in a dry place, away from sunlight.
• Dispose of device in accordance with hospital, administrative, and/or local government policy.
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