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Platinum Plus™ Guidewire .014" & .018"

Indications, Safety and Warnings

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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.

Platinum Plus Guidewire

INTENDED USE/INDICATIONS FOR USE

The Platinum Plus Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

CONTRAINDICATIONS

• Not intended for use in coronary arteries. • Not intended for use in the neurovasculature.

WARNINGS

• This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. • Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.

ADVERSE EVENTS

Potential adverse events which may result from the use of the device include but are not limited to:

• Air Embolism/Thromboembolism

• Allergic Reaction

• Amputation

• Arteriovenous (AV) Fistula

• Death

• Embolism

• Hematoma

• Hemorrhage

• Hemoglobinuria

• Infection or Sepsis/Infection

• Myocardial Ischemia and/or Infarction

• Pseudoaneurysm

• Stroke (CVA)/Transient Ischemic Attacks (TIA)

• Thrombus

• Vessel Occlusion

• Vessel Perforation, Dissection, Trauma, or Damage

• Vessel Spasm

• Wire Entrapment/Entanglement

• Foreign Body/Wire Fracture

Platinum Plus Guidewire with Glidex Hydrophilic Coating

INTENDED USE/INDICATIONS FOR USE

The Platinum Plus guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

CONTRAINDICATIONS

• Not intended for use in coronary arteries.

• Not intended for use in the neurovasculature.

WARNINGS

• This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.

• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.

• If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.

ADVERSE EVENTS

Potential adverse events which may result from the use of the device include but are not limited to:

• Air Embolism/Thromboembolism

• Allergic Reaction

• Amputation

• Arteriovenous (AV) Fistula

• Death

• Embolism

• Hematoma

• Hemorrhage

• Hemoglobinuria

• Infection or Sepsis/Infection

• Myocardial Ischemia and/or Infarction

• Pseudoaneurysm

• Stroke (CVA)/Transient Ischemic Attacks (TIA)

• Thrombus

• Vessel Occlusion

• Vessel Perforation, Dissection, Trauma, or Damage

• Vessel Spasm

• Wire Entrapment/Entanglement

• Foreign Body/Wire Fracture

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