Indications, Safety, and Warnings InTRAkit Access Kit

Important Information

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warning and precautions.


Indications for Use

The introducer sheath is used to facilitate placing a catheter through the skin and into a vein or artery, including, but not limited to, the radial artery. The micropuncture needle or IV catheter is used to gain access to a vein or artery, including, but not limited to, the radial artery, for placement of the mini-guidewire. The mini-guidewire is used for placement of the sheath into a vein or artery, including, but not limited to, the radial artery.


Contraindications

None known.


Warnings

Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient.

  • For single-patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a new risk of contamination of the device, which could result in patient injury, illness, or death. Cleaning, disinfection, and resterilization may compromise essential material and design characteristics of the device and lead to device failure.
  • Avoid use of alcohol, antiseptic solutions, and other solvents as they may adversely affect the surface of the introducer sheath.
  • Administer anticoagulation therapy to reduce potential thrombosis. If the patient is not anticoagulated, thrombus formation may occur.
  • Do not use excessive force when manipulating the introducer sheath, as this could cause product or vessel damage.
  • Do not inject drugs that include oil components such as lipid emulsions, castor oil, interfacial active agents, or solubilization agents such as alcohol, through the stopcock as these solvents may adversely affect the product.
  • When a catheter or vessel dilator is present inside the introducer sheath, do not flush the stopcock.

Precautions

  • Prior to a radial access procedure, verify that there is adequate collateral flow to the hand through the ulnar artery. Consider an alternate access site if there is insufficient flow.
  • This kit is intended for use by trained personnel.
  • Use kit immediately after opening package.
  • Use kit prior to the use-by date.
  • Store in a cool, dark, dry place.
  • Prior to use, confirm that introducer sheath size is appropriate for the access vessel and system to be used with this kit.
  • Do not use a metal cannula or micropuncture needle with a plastic-jacketed guidewire.
  • Do not attempt to reinsert a partially or completely withdrawn needle into the plastic IV cannula.
  • Do not aspirate from the stopcock with the guidewire in place through the hemostasis valve.
  • Do not use a power injector for contrast media injection through the stopcock.
  • Do not reshape the mini-guidewire. Do not turn the stopcock more than 180 degrees.
  • Use the mini-guidewire only to advance the introducer-sheath–vessel-dilator assembly.
  • Do not use sharp-edged tools or forceps on the introducer sheath or sideport tubing.
  • The entire procedure must be performed aseptically.
  • Do not use open or damaged packages.
  • After use, this product may be a potential biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Adverse Events

Adverse events that may occur or require intervention include, but are not limited to, the following:

  • Air embolism or thrombus formation
  • Arterial spasm
  • Hematoma
  • Infection
  • Intimal tear
  • Vessel perforation

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner.

See package inserts for the full product information.

Please contact your local Medtronic sales representative for more information.