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AccuStick™ Introducer System

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 AccuStick™ II Introducer System with radiopaque marker facilitates introduction and placement of a guidewire.

CONTRAINDICATIONS

None known.

PRECAUTIONS

None known.

WARNINGS

None known.

ADVERSE EVENTS

Potential risks exist for serious complications to include:

  • Perforation of a vessel or viscus
  • Laceration of a vessel or viscus
  • Bleeding
  • Wire or catheter embolism
  • Extravasation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Inflammation, necrosis or scarring
  • Risks normally associated with percutaneous interventional procedures
  • Pain in region
  • Skin infection
  • Edema

These and other complications are well documented in medical literature. Use of the AccuStick II Introducer System with radiopaque marker should be reserved by persons knowledgeable of the risks involved and qualified in the procedures.

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