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Fathom™ Steerable Guidewires

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

FATHOM -14 Steerable Guidewire

INTENDED USE/INDICATIONS FOR USE

The FATHOM -14 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

CONTRAINDICATIONS

None known.

WARNINGS

The FATHOM Steerable Guidewire is not intended for use in the coronary vasculature or the neuro vasculature.

ADVERSE EVENTS

Complications attributed to endovascular procedures are the following:

  • Vessel trauma
  • Vessel damage
  • Embolism (catheter/device, air bubble, plaque, thrombus, air embolism, thromboembolism)
  • Pseudoaneurysm
  • Seizure/stroke
  • Vessel dissection
  • Hematoma at the puncture site
  • Nerve injury
  • Infection
  • Perforation of the vessel
  • Vessel spasm
  • Hemorrhage
  • Vascular thrombosis
  • Vessel occlusion
  • Death
  • Bleeding
  • Failed treatment
  • Inability to position guidewire
  • Damage to the catheter

Fathom-16 Steerable Guidewire

INTENDED USE/INDICATIONS FOR USE

The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

CONTRAINDICATIONS

None known.

WARNINGS

The FATHOM Steerable Guidewire is not intended for use in the coronary vasculature or the neuro vasculature.

ADVERSE EVENTS

Complications attributed to endovascular procedures are the following:

  • Vessel trauma
  • Vessel damage
  • Embolism (catheter/device, air bubble, plaque, thrombus, air embolism, thromboembolism)
  • Pseudoaneurysm
  • Seizure/stroke
  • Vessel dissection
  • Hematoma at the puncture site
  • Nerve injury
  • Infection
  • Perforation of the vessel
  • Vessel spasm
  • Hemorrhage
  • Vascular thrombosis
  • Vessel occlusion
  • Death
  • Bleeding
  • Failed treatment
  • Inability to position guidewire
  • Damage to the catheter

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