SOFIA™ EX Indications, Safety, and Warnings

Warnings and Precaution

EMEA Region:

Warnings:

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

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

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

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

• The SOFIA™ EX Catheter must be used 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™ EX 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. Torqueing the SOFIA™ EX 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™ EX Catheter once the distal shaft of the SOFIA™ EX Catheter is placed inside the patient body.

Precautions:

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

• Verify compatibility of the SOFIA™ EX 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™ EX Catheter in tortuous vasculature to avoid damage. Avoid advancing or withdrawal against resistance until the cause of resistance is determined.

• Torqueing the device against resistance may result in damage to the vessel or device.

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

• Maintain perfusion of heparinized saline for inner lumen of the SOFIA™ EX Catheter to prevent thrombus formation. If removed from the patient, the hydrophilic coating on the SOFIA™ EX 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.

• Excessive torqueing of the catheter may cause damage which could result in kinking and possible separation along the catheter shaft. Should the system become severely kinked, withdraw the entire system if this occurs (SOFIA™ EX catheter, guidewire and catheter sheath introducer).

• 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. The risk of X-ray radiation exposure complications may increase as procedure time and number of procedures increase.

North America Region:

Warnings:

• The SOFIAEX Intracranial Support Catheter should only be used by physicians who have received appropriate training in interventional techniques.

• The safety and effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits for radial access against a transfemoral approach should be carefully weighed and considered for each patient.

• The SOFIAEX Intracranial Support Catheter is provided sterile and non-pyrogenic unless the unit package is opened or damaged. Visually inspect all the sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use if breaches in sterile barrier system integrity are evident, such as pouch is damaged, open.

• The SOFIA EX Intracranial Support Catheter is intended for single use only. Do not resterilize and/or reuse the device. After use, dispose device in accordance with hospital and/or government policy.

• Inspect the SOFIAEX Intracranial Support Catheter prior to use. Do not use the device if any damage or irregularities are observed.

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

• The SOFIAEX Intracranial Support Catheter must be used 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 SOFIAEX Intracranial Support 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 EX Intracranial Support Catheter for delivery of liquid embolic agents, including those containing dimethyl sulfoxide (DMSO) or n-butyl cyanoacrylate (n-BCA).

• 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 power injector to infuse via femoral artery access.

• Do not use automated high-pressure contrast injection equipment with the SOFIA EX Intracranial Support Catheter when using radial artery access as it may damage the device or injure the patient.

• Do not torque the catheter.

• Should the system become severely kinked, withdraw the entire system (SOFIA EX Intracranial Support Catheter, Compatible Microcatheter, Guidewire, and Catheter Sheath Introducer and/or Guide Catheter/Long Sheath as applicable).

• The Introducer Sheath is not intended for use inside the patient body. Ensure that the Introducer Sheath is removed from the SOFIAEX Intracranial Support Catheter once the distal shaft of the SOFIAEX Intracranial Support 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 SOFIAEX Intracranial Support Catheter to reduce the chance of accidental damage.

• Verify compatibility of the SOFIAEX Intracranial Support 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.

• If using radial artery access, perform a screening examination of the radial artery per institutional practices to ensure that radial access is appropriate for the patient.

• Do not shape the SOFIAEX Intracranial Support Catheter using steam (heat may damage this product).

• Use caution when manipulating the SOFIAEX Intracranial Support 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 SOFIAEX Intracranial Support Catheter and potentially affect its insertion or removal.

• Maintain perfusion of heparinized saline for inner lumen of the SOFIAEX Intracranial Support Catheter to prevent thrombus formation.

• If removed from the patient, the hydrophilic coating on the SOFIAEX Intracranial Support 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.