SOFIA™ Indications, Safety, and Warnings

Warnings and Precaution

Warnings:

• The SOFIA™ Catheter should only be used by physicians who have received appropriate training in interventional techniques.The SOFIA™ Catheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.

• Inspect the SOFIA™ Catheter prior to use. Do not use the device if any damages or irregularities are observed.

• Appropriate anti-coagulation and anti-platelet therapy should be administered per standard medical practice.

• The SOFIA™ Catheter 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 the SOFIA™ Catheter with Ethiodol or Lipiodol contrast media or other such contrast media which includes the components of those agents. Do not use organic solvents as the device may be damaged.

• Do not exceed 2070 kPa (300 psi) maximum recommended infusion pressure. Excess pressure may damage the device or injure the patient. Carefully monitor placement of the distal tip when using a power injector to infuse. Do not make more than 90 degree angle on the Shaping Mandrel. Steaming of the distal tip with more than 90 degree angle may result in damage to the device.

• Do not steam the same device more than once, which may result in damage to the device.

• Torquing the SOFIA™ Catheter excessively while kinked may damage the device resulting in separation of the device. Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked. The Introducer Sheath is not intended for use inside the patient body. Ensure that the Introducer Sheath is removed from the SOFIA™ Catheter once the distal shaft of the SOFIA™ Catheter is placed inside the patient body.

• Excessive aspiration with the distal tip of the SOFIA™ Catheter covered by the vessel wall may cause vessel injury. Carefully investigate location of the distal tip under fluoroscopy prior to aspiration.

• Do not attempt to clear the inner lumen of the SOFIA™ Catheter by infusion while keeping the device in the patient body.

• When flow from the lumen stops or becomes stagnant during aspiration, do not attempt to clear the inner lumen of the SOFIA™ Catheter by infusion while keeping the device in the patient body.

Precautions:

• Exercise care in handling the SOFIA™ Catheter to reduce the chance of accidental damage.

• Verify compatibility of the SOFIA™ Catheter when using other ancillary devices commonly used in intravascular procedures. The physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.

• Use caution when manipulating the SOFIA™ Catheter in tortuous vasculature to avoid damage. Avoid advancing or withdrawal against resistance until the cause of resistance is determined.

• Presence of calcifications, irregularities, or other devices may damage the SOFIA™ Catheter and potentially affect its insertion or removal.

• Maintain perfusion of heparinized saline for inner lumen of the SOFIA™ Catheter to prevent thrombus formation.

• If removed from the patient, the hydrophilic coating on the SOFIA™ Catheter should be hydrated with heparinized saline. Do not allow the coating to dry.