105F-BER-130

Indications, Safety, and WarningsCaution

Federal Law (USA) restricts this device to sale 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.

Indications for useThe 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.ContraindicationsThere are no known contraindicationsWarnings

Vasospasm is a potential complication and may lead to entrapment of the device. Medical management of procedural vasospasm should be in line with standard medical practice.

When the Selective Catheter is introduced to the vascular system, it should be manipulated while under high-quailty fluoroscopic observation to minimize risk of procedural complications such as devices entering unintended anatomy or radial artery anomalies such as radial loops. Do not advance or retract the Selective Catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding.

Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in 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.

Excessive manipulation of the device can increase the risk of patient complications.

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 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.

Do not deliver through anatomical anomalies such as radial loops.

This device should be used only when femoral artery access is not feasible.

The risks and benefits of radial access compared to transfemoral access 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.

Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.

After radial access is achieved, torquing or moving the device against resistance may result in damage to the vessel or device separation, which may lead to potential complications, additional surgical procedures to remove device fragments, aborted or prolonged procedures.

Precautions

Use the device only prior to the “Use-by date” listed on the package label.

Prior to beginning radial artery access, perform a patency assessment such as an Allen or Barbeau test to ensure adequate collateral circulation of the hand.

Radial artery measurement with ultrasound is recommended to ensure compatibility for radial access and correct device sizing selection.

The selected device outer diameter should be smaller than the inner diameter of the radial artery to minimize the risk of complications.

Perform a screening examination of the radial artery, such as an ultrasound assessment, to ensure that radial artery access is appropriate for the patient.

The radial artery lumen diameter must be larger than the outer diameter of the Rist Catheter.

If using a guide catheter and/or an introducer sheath with the Rist Catheter, ensure the radial artery lumen diameter is larger than the outer diameter of the guide catheter and the introducer sheath.

The Rist™ Radial Access Selective Catheter is designed to be used under high-quality fluoroscopic observation.

Do not advance the guide catheter over the Rist™ Radial Access Selective Catheter while forming the shape Doing so may cause Rist™ Radial Access Selective Catheter to kink.

Vasospasm may occur from accessing the radial artery, thus reducing vessel lumen diameter below that which was anticipated or measured prior to the procedure.

Vasospasm may occure while the device is within the artery. Manipulations of the device or device system increase the risk of vasospasm.

Resistance or entrapment during a procedure may be indicative of vasospasm. Vasodilators or other appropriate therapies such as anti-coagulation, should be administered in accordance with standard medical practice and guidelines.

The Rist™ Radial Access Selective Catheter should not be used as a dilator for sheathless insertion of a guide catheter.

Maintain a constant infusion of appropriate flush solution.

All agents to be infused must be used according to the manufacturer’s Instructions for Use.

The maximum permissible pressure for the Rist™ Radial Access Selective Catheter is 600 psi (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 flow rates for catheter use in diagnostic procedures Flowrates were determined using a 50/50 mixture of Saline/Omnipaque 300 at 23 C using the 130 cm working length catheter.

Table 2: 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

If flow through the catheter becomes restricted, remove and replace the device. Do not attempt to clear the catheter lumen by flushing it.

Flush the entire device with heparinized saline prior to placement to avoid accidental introduction of air into the system.

For other devices and fluids not supplied within this package but used in conjunction with this product, please refer to their respective Instructions for Use.

Potential ComplicationsPotential complications of the device and the endovascular procedure include or are synonymous with, but may not be limited to:

Access site complications including sterile inflammation, granulomas, hemorrhage, hematoma, infection, nerve damage, pathological hand cold intolerance, pain and tenderness, radial artery occlusion, pseudoaneurysm, arteriovenous fistula, tissue necrosis, vasospasm, vessel dissection, compartment syndrome, amputation, vessel avulsion, hand dysfunction, radial artery perforation

Allergic reaction including anaphylaxis from contrast media and contrast media related risks (e.g.kidney damage), hypersensitivity, foreign body reaction or adverse complication of anesthesia including aspiration

Cardiac complications including arrhythmia, myocardial infarction

Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts and delayed neoplasia

Device complications including fracture, kink, friction, material left in patient

Hematologic complications including coagulopathy, hemolysis, hemorrhage, intracranial hemorrhage

Neurological defict/dysfuntions including stroke/cerebral infarction

Systemic complications including hypotension, hypertension, fever, organ failure, shock, toxicity, edema (localized or generalized)

Therapeutic response decreased

Vascular complications including abscess, embolism (including air embolism and distal embolization to previously uninvolved territory), thromboembolism, thrombus/thrombsis, occlusion, stenosis, ischemia, fistula, perforation, rupture, vasoconstriction, extravasation

Vision symptoms including impaired vision and vision loss

Knot

Death

*Consult Instructions for Use for other therapy devices and fluids for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device or viewed at www.medtronic.com/manualsUS-NNP-2400090 (v2.0)

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