WEDGE™ Indications, Safety, and Warnings

Warnings:

The Wedge™ 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 Wedge™ 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 Wedge™ Microcatheter is intended for single use only. Do not resterilize and/or reuse the device. After use, dispose device in accordance with hospital and/or local government policy.
Inspect the Wedge™ Microcatheter prior to use for any irregularities or damage and discard if any inconsistencies are observed.
The Wedge™ 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 300 psi to avoid potential rupture of the Wedge™ Microcatheter.
The shaping mandrel is not intended for use inside the body. Ensure shaping mandrel is removed from Wedge™ Microcatheter prior to introduction into the RHV or other accessories.

Precautions:

Verify Wedge™ 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 Wedge™ Microcatheter has a lubricious surface and should be hydrated prior to use.
Exercise care in handling the Wedge™ Microcatheter to reduce the chance of accidental damage.
Verify that the diameter of any guidewire or accessory device that is used is compatible with the inner diameter of the Wedge™ 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 Wedge™ Microcatheter.
Take precaution when manipulating the Wedge™ Microcatheter in tortuous vasculature to avoid damage to the Wedge™ Microcatheter. Avoid advancing or withdrawal against resistance until the cause of resistance is determined.