SOFIA™ Flow 88 Indications, Safety, and Warnings

Warnings and Precaution

Warnings:

• The SOFIA Flow 88 Aspiration Catheter should only be used by physicians who have received appropriate training in interventional techniques.

• The SOFIA Flow 88 Aspiration Catheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.

• Inspect the SOFIA Flow 88 Aspiration 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 Flow 88 Aspiration 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 Flow 88 Aspiration 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 use automated high-pressure contrast injection equipment with the SOFIA Flow 88 Aspiration Catheter as it may damage the device.

• Do not exceed 2070 kPa (300 psi) maximum recommended infusion pressure. Excess pressure may damage the device or injure the patient.

• Torquing the SOFIA Flow 88 Aspiration Catheter excessively while kinked may damage the device, resulting in separation of the device. Withdraw the entire device (the device, Compatible Catheter, 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 Flow 88 Aspiration Catheter once the distal shaft of the SOFIA Flow 88 Aspiration Catheter is placed inside the patient body.

• Excessive aspiration with the distal tip of the SOFIA Flow 88 Aspiration 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 Flow 88 Aspiration 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 Flow 88 Aspiration Catheter by infusion while keeping the device in the patient body.

Precautions:

• Exercise care in handling the SOFIA Flow 88 Aspiration Catheter to reduce the chance of accidental damage.

• Verify compatibility of the SOFIA Flow 88 Aspiration 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 Flow 88 Aspiration 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 Flow 88 Aspiration Catheter and potentially affect its insertion or removal.

• Maintain perfusion of heparinized saline for inner lumen of the SOFIA Flow 88 Aspiration Catheter to prevent thrombus formation.

• If removed from the patient, the hydrophilic coating on the SOFIA Flow 88 Aspiration Catheter should be hydrated with heparinized saline. Do not allow the coating to dry.