HEADWAY™ Indications, Safety, and Warnings

Warnings and Precaution

Headway™

Warnings:

The Microcatheter should only be used by physicians who are familiar with angiographic and interventional procedures. It is important to follow the instructions for use prior to using this product.The Microcatheter is provided sterile and non-pyrogenic unless the unit package is opened or damaged. Do not use if the packaging is breached or damaged.The Microcatheter is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.After use, dispose device in accordance with hospital and/or local government policy.Inspect the Microcatheter prior to use for any irregularities or damage and discard if any inconsistencies are observed.The Microcatheter should be advanced or manipulated under fluoroscopic guidance. Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined. Infusion pressure should not exceed 700 psi to avoid potential rupture of the Microcatheter.Shaping mandrel is not intended for use inside the body. Ensure shaping mandrel is removed from Microcatheter prior to introduction into the RHV or other accessories

Precautions:

Verify Microcatheter compatibility when using other ancillary devices commonly used in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure. The Microcatheter has a lubricious surface and should be hydrated prior to use.Exercise care in handling the Microcatheter to reduce the chance of accidental damage. With the exception of dimethyl sulfoxide (DMSO), use of organic solvents may damage the Microcatheter and/or coating on the surface.Verify that the diameter of any guidewire or accessory device that is used is compatible with the inner diameter of the Microcatheter prior to use.Potential complications include, but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.To reduce the risk of damage or separation of the device, avoid repeated bending at the same point of the Microcatheter.Take precaution when manipulating the Microcatheter in tortuous vasculature to avoid damage to the Microcatheter. Avoid advancing or withdrawal against resistance until the cause of resistance is determined

Headway DUO

Warnings:

The Microcatheter should only be used by physicians who are familiar with angiographic and interventional procedures. It is important to follow the instructions for use prior to using this product.The Microcatheter is provided sterile and non-pyrogenic unless the unit package is opened or damaged. Do not use if the packaging is breached or damaged.The Microcatheter is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.After use, dispose device in accordance with hospital and/or local government policy.Inspect the Microcatheter prior to use for any irregularities or damage and discard if any inconsistencies are observed.The Microcatheter should be advanced or manipulated under fluoroscopic guidance. Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined. Infusion pressure should not exceed 700 psi to avoid potential rupture of the Microcatheter.Shaping mandrel is not intended for use inside the body. Ensure shaping mandrel is removed from Microcatheter prior to introduction into the RHV or other accessories

Precautions:

Verify Microcatheter compatibility when using other ancillary devices commonly used in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure. The Microcatheter has a lubricious surface and should be hydrated prior to use.Exercise care in handling the Microcatheter to reduce the chance of accidental damage. With the exception of dimethyl sulfoxide (DMSO), use of organic solvents may damage the Microcatheter and/or coating on the surface.Verify that the diameter of any guidewire or accessory device that is used is compatible with the inner diameter of the Microcatheter prior to use.Potential complications include, but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.To reduce the risk of damage or separation of the device, avoid repeated bending at the same point of the Microcatheter.Take precaution when manipulating the Microcatheter in tortuous vasculature to avoid damage to the Microcatheter. Avoid advancing or withdrawal against resistance until the cause of resistance is determined