TRUSELECT™ Microcatheter
Brief Summary

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE

The TRUSELECT Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

CONTRAINDICATIONS

None known.

WARNINGS

  • Never advance or withdraw an intravascular device against resistance until the cause of resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in damage or separation of the microcatheter or guidewire tip, or vessel perforation.
  • TRUSELECTTM Microcatheter is not intended for use in the coronary vasculature or neurovasculature.

PRECAUTIONS

  • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.
  • Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
  • Because the microcatheter may be advanced into narrow sub-selective vasculature, repeatedly assure that the microcatheter has not been advanced so far as to interfere with its removal.

ADVERSE EVENTS

The Adverse Events include, but are not limited to:

  • Allergic reaction (to drug, contrast, device or other)
  • Cerebrovascular accident (CVA), stroke, transient ischemic attack (TIA)
  • Death
  • Embolism (air, plaque, thrombus, device or other)
  • Hemorrhage/Hematoma
  • Infection/sepsis
  • Need for urgent intervention or surgery
  • Thrombus/thrombosis
  • Vasospasm
  • Vessel occlusion
  • Vessel trauma (perforation, injury, rupture, dissection, pseudoaneurysm)
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