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Coyote™ Balloon Dilatation Catheter

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.

Coyote OTW

INTENDED USE/ INDICATIONS FOR USE

The Coyote OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

CONTRAINDICATIONS

None Known.

WARNINGS

  • Any use for procedures other than those indicated in these instructions is not recommended.

PRECAUTIONS

  • The Coyote OTW PTA Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty.
  • The Coyote OTW PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these inflation sites.
  • The Coyote OTW PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.
  • Precautions to prevent or reduce clotting should be taken when any catheter is used:
  • Consider systemic anticoagulation.
  • Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.
  • Consult the manufacturers instructions for use when using distal embolic protection devices during angioplasty.

ADVERSE EVENTS

The complications that may result from a balloon dilatation procedure include, but are not limited to:

  • Allergic reaction (device, contrast medium and medications)
  • Arteriovenous fistula
  • Embolization (air, device, plaque, etc.)
  • Hematoma
  • Hemorrhage, including bleeding at puncture site
  • Pseudoaneurysm
  • Sepsis/infection
  • Thromboembolic episodes
  • Vessel injury, e.g. dissection, perforation, rupture
  • Vessel occlusion
  • Vessel spasm

Coyote Monorail

INTENDED USE/ INDICATIONS FOR USE

The Coyote MONORAIL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

CONTRAINDICATIONS

None Known.

WARNINGS

  • Any use for procedures other than those indicated in these instructions is not recommended.

PRECAUTIONS

  • The Coyote MONORAIL PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these inflation sites.
  • The Coyote MONORAIL PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.
  • Precautions to prevent or reduce clotting should be taken when any catheter is used:
  • Consider systemic anticoagulation.
  • Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.
  • Consult the manufacturers instructions for use when using distal embolic protection devices during angioplasty.

ADVERSE EVENTS

The complications that may result from a balloon dilatation procedure include, but are not limited to:

  • Allergic reaction (device, contrast medium and medications)
  • Arteriovenous fistula
  • Embolization (air, device, plaque, etc.)
  • Hematoma
  • Hemorrhage, including bleeding at puncture site
  • Pseudoaneurysm
  • Sepsis/infection
  • Thromboembolic episodes
  • Vessel injury, e.g. dissection, perforation, rupture
  • Vessel occlusion
  • Vessel spasm

Coyote ES OTW

INTENDED USE/INDICATIONS FOR USE

The Coyote ES OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.00 mm-4.00 mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

CONTRAINDICATIONS

None Known.

GENERAL PRECAUTIONS

The Coyote ES OTW PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these lesions.

The Coyote ES OTW PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.

Precautions to prevent or reduce clotting should be taken when any catheter is used:

  • Consider systemic heparinization.
  • Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.

ADVERSE EVENTS

The complications that may result from a balloon dilatation procedure include, but are not limited to:

  • Abrupt closure
  • Allergic reaction (device, contrast medium and medications)
  • Amputation
  • Aneurysm
  • Angina
  • Arrhythmias, including ventricular fibrillation
  • Arteriovenous fistula
  • Coma
  • Death
  • Deep vein thrombosis
  • Embolization air, device, plaque, etc.
  • Hematoma
  • Hemorrhage, including bleeding at puncture site
  • Hypotension/Hypertension
  • Infection, local or systemic
  • Ischemia, including tissue ischemia, steal syndrome and necrosis
  • Myocardial ischemia or infarction
  • Need for additional intervention or surgery
  • Neuropathies or nerve injury
  • Organ failure (single, multiple)
  • Pulmonary embolus
  • Pain
  • Pseudoaneurysm
  • Renal failure
  • Restenosis
  • Shock
  • Stroke
  • Vessel injury, e.g. dissection, perforation, other claudication
  • Vessel occlusion
  • Vessel spasm
  • Vessel thrombosis

Coyote ES Monorail

INTENDED USE/INDICATIONS FOR USE

The Coyote ES Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.00 mm-4.00 mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

CONTRAINDICATIONS

None Known.

WARNINGS

The Coyote ES Monorail PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these lesions.

The Coyote ES Monorail PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.

Precautions to prevent or reduce clotting should be taken when any catheter is used:

  • Consider systemic heparinization.
  • Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.

ADVERSE EVENTS

The complications that may result from a balloon dilatation procedure include, but are not limited to:

  • Abrupt closure
  • Allergic reaction (device, contrast medium and medications)
  • Amputation
  • Aneurysm
  • Angina
  • Arrhythmias, including ventricular fibrillation
  • Arteriovenous fistula
  • Coma
  • Death
  • Deep vein thrombosis
  • Embolization air, device, plaque, etc.
  • Hematoma
  • Hemorrhage, including bleeding at puncture site
  • Hypotension/Hypertension
  • Infection, local or systemic
  • Ischemia, including tissue ischemia, steal syndrome and necrosis
  • Myocardial ischemia or infarction
  • Need for additional intervention or surgery
  • Neuropathies or nerve injury
  • Organ failure (single, multiple)
  • Pulmonary embolus
  • Pain
  • Pseudoaneurysm
  • Renal failure
  • Restenosis
  • Shock
  • Stroke
  • Vessel injury, e.g. dissection, perforation, other claudication
  • Vessel occlusion
  • Vessel spasm
  • Vessel thrombosis
  • Weakness
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