Renegade™ HI-FLO™

Microcatheter, Kits and Systems

Indications, Safety, and Warnings

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Prescriptive Information

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 “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Renegade STC 18 Microcatheter, Renegade Fiber Braided Microcatheter, and the Renegade HI-FLO Microcatheter are intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

CONTRAINDICATIONS

None Known.

WARNINGS

The Renegade STC 18 Microcatheter, Renegade Fiber Braided Microcatheter, and the Renegade HI-FLO Microcatheter are not intended for use in the coronary vasculature or the neurovasculature.

PRECAUTIONS

  • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.
  • Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in separation of the microcatheter or guidewire tip, damage to the microcatheter or guidewire tip, or vessel perforation.
  • Because the microcatheter may be advanced into narrow subselective 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:

  • Vessel trauma
  • Embolism
  • Hemorrhage/Hematoma
  • Vasospasm
  • Infection
  • Air embolism
  • Allergic reaction
 

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