SOFIA™ 88 Indications, Safety, and Warnings

Warnings and Precaution

Warnings:

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

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

• Inspect the SOFIA 88 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 88 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.

• Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.

• Do not use the SOFIA 88 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 the SOFIA 88 Catheter for delivery of liquid embolic agents, including those containing dimethyl sulfoxide (DMSO) or n-butyl cyanoacrylate (n-BCA).

• Do not use automated high-pressure contrast injection equipment with the SOFIA 88 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 88 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 88 Catheter once the distal shaft of the SOFIA 88 Catheter is placed inside the patient body.

• Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions:

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

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

• Maintain perfusion of heparinized saline for inner lumen of the SOFIA 88 Catheter to prevent thrombus formation. If removed from the patient, the hydrophilic coating on the SOFIA 88 Catheter should be hydrated with heparinized saline.

• Do not allow the coating to dry as this may impact the coating safety and performance.

• Avoid pre-soaking devices for long durations when the device is not in use as this may impact the coating safety and performance.

• Avoid wiping the device with dry gauze as this may damage the device coating. Avoid excessive wiping of the coated device.