Chaperon™ Indications, Safety, and Warnings

Warnings and Precaution

WARNINGS

The device 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 device 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 device is intended for single use only. Do not resterilize and/or reuse the device. After use, dispose in accordance with hospital and/or local government policy. Inspect the device prior to use for any irregularities or damage and discard if observed. The device should be manipulated under fluoroscopic guidance. Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined. Do not use with Ethiodol or Lipiodol contrast media, or other such contrast media which includes the components of those agents.

PRECAUTIONS

Verify the device compatibility when using other ancillary devices commonly used in intravascular procedures. Physician must be familiar with percutaneous, intravascular technique and possible complications associated with these procedures. Exercise care in handling the device to reduce the chance of accidental damage. Do not expose the device to organic solvents such as alcohol or medications, which might damage the device. 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, thrombus formation, and death. Extreme care must be taken to avoid damage to the vasculature through which the device passes. The device may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage. Torqueing a kinked device excessively may result in separation of components from the device. Do not continue to use the device if it is severely kinked from any cause and withdraw the entire system (the device and guidewire, and sheath introducer if necessary). Exercise care when manipulating the device in tortuous vasculature to avoid damage to the device.