Indications, safety, and warnings The Rist™ Radial Access Selective Catheter Rist™ 079 Radial Access Guide Catheter

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RIST™ RADIAL ACCESS SYSTEM 

The Rist™ Radial Access Selective Catheter
Rist™ 079 Radial Access Guide Catheter

INDICATIONS FOR USE

The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neurovasculature. It can be used to facilitate introduction of diagnostic agents in the neurovasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neurovasculature.

CAUTION

Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNINGS

For Rist™ 079 Radial Access Guide Catheter

  • Contents supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Medtronic Neurovascular representative.
  • Do not use if labeling is incomplete or illegible.
  • 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 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.
  • When the Guide Catheter is introduced to the vascular system, it should be manipulated while under high- quality fluoroscopic 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 and directions sections 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 labeling may result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

For Radial Access Selective Catheter

  • 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 effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits 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.
  • Sufficient shielding, reduced fluoroscopy times, and modified X-ray technical factors should be used when possible to limit patient and physician exposure to X-ray radiation doses.

PRECAUTION

For Rist™ 079 Radial Access Guide Catheter

  • The Rist™ 079 Radial Access Guide Catheter must only be used by physicians trained in intravascular intervention.
  • Use the device prior to the “Use By” date specified on the package.
  • Maintain a constant infusion of appropriate flush solution.
  • If flow 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 specific procedure for which it is to be used.
  • The Rist™ 079 Radial Access Guide Catheter should be used only by physicians trained in percutaneous procedures and/or interventional techniques.
  • 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.
  • Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when 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 affect the device safety and performance.
  • Use an appropriate hemostasis valve during the procedure.

For Rist™ Radial Access Selective Catheter

  • The Rist™ Radial Access Selective Catheter must only be used by physicians trained in intravascular intervention
  • This product is supplied sterile using an ethylene oxide (EO) process.
  • Use the device only prior to the “Use By” date listed on the package label.
  • The Rist™ Radial Access Selective Catheter is designed to be used under high-quality fluoroscopic observation.
  • When the catheter is introduced to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding.
  • 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.
  • Do not apply excessive torque or rotation to the system.
  • The Rist™ Radial Access Selective Catheter should not be used as a dilator for sheathless insertion of a long sheath.
  • 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 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 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 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
  • 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.
  • 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.

 

POTENTIAL COMPLICATIONS

  • Air Embolism
  • Allergic Reaction
  • Death
  • Embolism
  • False Aneurysm Formation
  • Fistula
  • Hemorrhage
  • Hypersensitivity
  • Hypotension
  • Infection
  • Inflammation
  • Intracranial hemorrhage
  • Ischemia
  • Material Left in Patient
  • Neurological deficit/ dysfunction
  • Occlusion
  • Organ failure
  • Pain And Tenderness
  • 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