Essential Product Information
The RADIALSOURCE™ Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
Radial access is contraindicated in patients with:
- Inadequate circulation to the extremity as evidenced by signs of artery occlusion or absence of radial pulse.
- Hemodialysis shunt, graft or arterio-venous fistula involving the upper extremity vasculature.
- Prior to radial access procedures, it is recommended to verify adequate collateral flow through the ulnar artery. If collateral blood supply to the hand is considered inadequate, an alternate access site should be considered.
- This product is designed and intended for single use. DO NOT REUSE, DO NOT RESTERILIZE.
- Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
- Cleaning, disinfection and sterilization may compromise essential material and design characteristics leading to device failure.
- Do not use Ethiodol* or Lipiodol contrast media, or other such contrast media which incorporates the components of these agents, as solvents used in these media may have a deleterious effect upon the CSI.
- Best practices call for meticulous flushing of indwelling sheath introducers to help reduce the incidence of thrombus formation.
- Do not reinsert the needle into the IV catheter at any time. The needle, sharp or blunted, could damage the IV catheter, resulting in an IV
- Use of alcohol, antiseptic solutions, or other solvents should be avoided, as they may adversely affect the surface of the CSI.
- Do not thread the polymer-coated guidewire down the metal cannula of the needle as it may damage the coating causing an embolus.
- Apply appropriate anticoagulant therapy to the patient.
- Remove components from tray in order of recommended procedure, otherwise damage may occur to introducer or vessel dilator.
- Manipulate the mini-guidewire slowly and carefully to avoid damage to the vessel wall, while monitoring tip position and movement under fluoroscopy
- Excessive sheath withdrawal force can cause product or vessel damage.
- Do not aspirate with a guidewire in place through the hemostasis valve. Aspiration with the guidewire through the valve may cause an air embolism which can result in significant morbidity or death.
- This kit is intended for use by trained personnel under fluoroscopy.
- Use kit immediately after opening package.
- Store in a cool, dark, dry place.
- Prior to use, confirm that sheath size is appropriate for the access vessel and system to be used with this kit.
- The entire procedure from skin stick to sheath removal must be performed aseptically.
- Do not use a power injector for contrast media injection through the side-port assembly, as the CSI gasket is not designed to withstand high pressure.
- Do not inject drugs including oil components such as lipid emulsions, castor oil, interfacial active agents, or solubilization agents such as alcohol through the sideport assembly, as these solvents may adversely affect the stopcock.
- Do not use open or damaged packages.
- Take care to not cut the side port tubing.
- Use prior to the “Use By” date.
- The RADIALSOURCE™ Catheter Sheath Introducer is not designed for blood pressure monitoring or repeated sampling of arterial blood.
- This kit is intended for vascular (including radial) access. No data have been collected to demonstrate the safety and effectiveness of this kit for use in transradial coronary artery procedures.
Possible complications include, but are not limited to:
- Air embolism
- Intimal tear
- Perforation of the vessel wall
- Thrombus formation
- Arterial spasm
- Periprocedural bleeding
- Injury to adjacent structures leading to pseudoaneurysm, AV fistula or radial nerve damage.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See package insert for full product information.
See package insert for full product information.
*Ethiodol is a trademark of Guerbet S.A.