Marksman Micro Catheter INDICATIONS, SAFETY, AND WARNINGS

INDICATIONS FOR USE

The Marksman™ micro catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculature.

COMPATIBILITY

DEVICE DESCRIPTION SIZE

Guiding Catheter

≥ 5 Fr

Guidewire

≤ 0.021" (0.053 mm)

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to, the following:

  • Distal emboli (air, foreign material, tissue, or thrombus)
  • Hematoma
  • Hemorrhage
  • Infection
  • Ischemia
  • Pain at insertion site
  • Neurological deficit that could lead to stroke and death
  • Vessel spasm, dissection, perforation or injury

WARNINGS

  • THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. Discard after one procedure. Structural integrity and/or function may be impaired after reuse or cleaning.
  • The catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
  • Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.
  • Static pressure for this catheter should not exceed 400 psi.
  • This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.