Medtronic 105F-BER-120 Instructions for Use
Rist™
Radial Access Selective Catheter
Table Of Contents
Rist™ Radial Access Selective Catheter
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Instructions for Use
CAUTION
Federal Law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The Rist™ Radial Access Selective Catheter is a exible, single lumen catheter compatible with 0.035-in and
0.038-in guidewires. The braided, tapered shaft of the catheter is visible under uoroscopy and has a luer
connector in its proximal end for the attachment of accessories and the infusion of uids. The Rist™ Radial
Access Selective Catheter is oered in dierent lengths and distal segment shapes. The Rist™ Radial Access
Selective Catheter has no hydrophilic coating. The Rist™ Radial Access Selective Catheter can be used to aid
in the delivery of guide catheters and long sheaths with inner diameter of 0.070-in or larger.
INTENDED PURPOSE/INDICATIONS FOR USE
The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the
peripheral, coronary and neuro vasculature. It can be used to facilitate introduction of diagnostic agents in
the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or
peripheral arteries.
CONTRAINDICATIONS
There are no known contraindications.
PREPARATION AND USE
1. For diagnostic and interventional procedures, select the Rist™ Radial Access Selective Catheter tip shape
and length appropriate to the anatomy.
2. Open the packaging pouch and remove the Rist™ Radial Access Selective Catheter from its packaging
card.
3. Inspect the entire device to verify that it is undamaged.
4. Flush the Rist™ Radial Access Selective Catheter with heparinized saline solution.
5. Connect a rotating hemostasis valve (RHV) to the hub of the Rist™ Radial Access Selective Catheter.
Connect heparinized saline ush to the Rist™ Radial Access Selective Catheter.
6. Insert a 0.035-in or 0.038-in guidewire of appropriate length into the Rist™ Radial Access Selective
Catheter until it is just proximal to the tip.
7. Prepare guide catheter or long sheath to be delivered according to its Instructions for Use.
8. Insert the Rist™ Radial Access Selective Catheter/Guidewire Assembly into the guide catheter/long
sheath and advance the assembly until the distal tip protrudes from the distal tip of the guide catheter/
long sheath.
9. Gain primary radial artery access using standard technique.
10. Advance the Rist™ Radial Access Selective Catheter and guide catheter/long sheath system through the
introducer sheath, if using a short sheath.
11. If not using a short sheath, insert guide catheter/long sheath with a dilator. Remove dilator, then
introduce Rist™ Radial Access Selective Catheter.
12. Advance the Rist™ Radial Access Selective Catheter and guide catheter/long sheath simultaneously over
the compatible guidewire until the Rist™ Radial Access Selective Catheter reaches the aortic arch under
uoroscopic guidance.
13. Retract the guidewire and use standard technique to form the Rist™ Radial Access Selective Catheter to
select/reach the desired vasculature.
14. If using the Rist™ Radial Access Selective Catheter in diagnostic procedures (with diagnostic agents in
the neurovasculature), consult Table 1. Diagnostic Catheter Pressure at Common Flow Rates. The device
is not intended for introduction of diagnostic agents in coronary or peripheral vasculature.
15. After gaining access to the desired vessel location with the Rist™ Radial Access Selective Catheter,
advance the guide catheter/long sheath over the Rist™ Radial Access Selective Catheter to the desired
vessel location.
16. Remove the Rist™ Radial Access Selective Catheter and guidewire while maintaining the guide catheter
or long sheath in position.
17. 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.
POTENTIAL COMPLICATIONS
• Air Embolism
• Allergic Reaction
• 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
• Radial Artery Occlusion
• Stenosis
• Stroke/ Cerebral infarction
• Therapeutic response decreased
• Thromboembolism
• Thrombus/ Thrombosis
• Vessel Collapse
• Vessel Dissection
• Vision symptoms
• Vessel Perforation or Rupture
• Vessel Spasm/ Vasoconstriction
WARNINGS
• Contents supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged.
• 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 Neurovascular
representative.
• 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 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.
• The safety and eectiveness of this device for radial neurovasculature access in direct comparison to a
transfemoral approach has not been demonstrated. The risks and benets for radial access against a
transfemoral approach should be carefully weighed and considered for each patient.
• Appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with
standard medical practice.
• Sucient shielding, reduced uoroscopy times, and modied X-ray technical factors should be used
when possible to limit patient and physician exposure to X-ray radiation doses.
PRECAUTIONS
1. The Rist™ Radial Access Selective Catheter must only be used by physicians trained in intravascular
intervention
2. This product is supplied sterile using an ethylene oxide (EO) process.
3. Use the device only prior to the “Use By” date listed on the package label.
4. The Rist™ Radial Access Selective Catheter is designed to be used under high-quality uoroscopic
observation.
5. When the catheter is introduced to the vascular system, it should be manipulated while under highquality uoroscopic observation. Do not advance or retract the catheter if resistance is met during
manipulation; determine the cause of the resistance before proceeding.
6. Do not advance the guide catheter or long sheath over the Rist™ Radial Access Selective Catheter while
forming the shape. Doing so may cause Rist™ Radial Access Selective Catheter to kink.
7. Do not apply excessive torque or rotation to the system.
8. The Rist™ Radial Access Selective Catheter should not be used as a dilator for sheathless insertion of a
long sheath.
9. Maintain a constant infusion of appropriate ush solution.
10. All agents to be infused must be used according to the manufacturer’s instructions for use.
11. The maximum permissible pressure for the Rist™ Radial Access Selective Catheter is 600psi (4136 kPa).
Do not exceed the maximum permissible injection pressure as it may damage the device or injure the
patient. See table below for pressures and ow rates for catheter use in diagnostic procedures. Flowrates
were determined using a 50/50 mixture of Saline/Omnipaque 300 at 23°C using the 130cm working
length catheter.
Table 1. Diagnostic Catheter Pressure at Common Flow Rates
Flowrate (mL/s) 4 6 8 10
Pressure (PSI) 100 203 341 501
Pressure (kPa) 689 1400 2351 3454
12. If ow through the catheter becomes restricted, remove and replace the device. Do not attempt to clear
the catheter lumen by ushing it.
13. Flush the entire device with heparinized saline prior to placement to avoid accidental introduction of air
into the system.
14. Prior to beginning radial artery access, perform an assessment of the collateral circulation of the hand to
ensure that radial access is appropriate for the patient.
HANDLING AND STORAGE
This device should be stored in a dry place, away from sunlight.
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