ERIC™ Indications, Safety, and Warnings

Warnings and Precaution

WARNINGS

• The ERIC Retrieval Device should only be used by physicians who have received appropriate training in interventional techniques.

• The ERIC Retrieval Device is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.

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

• Administer IV thrombolytic therapy as soon as possible for all patients who are indicated to receive the drug. Do not cause delays in this therapy. Refer to the IV thrombolytic therapy manufacturer labeling for indications, contraindications, warnings, precautions, potential complications, and instructions for use.

• Verify the size of the vessel under fluoroscopy. Ensure that the ERIC Retrieval Device is appropriate for the size of the vessel. Do not oversize device.

• Do not advance or withdraw the ERIC Retrieval Device when excessive resistance is observed. Assess the source of resistance using fluoroscopic means. If needed, resheath the ERIC Retrieval Device into the Microcatheter and remove the entire system under aspiration. If resistance is encountered during resheathing, stop resheathing and remove the entire system under aspiration.

• Position the distal tip marker of Microcatheter just proximal to the retrieval spheres after deployment of the ERIC Retrieval Device and maintain the distal tip marker in the same position during withdrawal to reduce risk of device fracture.

• Do not perform more than three (3) retrieval attempts in the same vessel using the ERIC Retrieval Device.

• Do not apply excessive force to the distal tip of the ERIC Retrieval Device when cleaning the device for additional retrieval attempts.

• Do not torque the ERIC Retrieval Device.

• Ensure during cleaning of the ERIC Retrieval Device that all foreign components (e.g., clot, fibers) are fully removed before reinsertion.

PRECAUTIONS

• Initiate mechanical neurothrombectomy as soon as possible.

• Exercise care in handling the ERIC Retrieval Device to reduce the chance of accidental damage.

• Use of other organic solvents may damage the ERIC Retrieval Device.

• Carefully inspect the sterile package and the ERIC Retrieval Device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.

• Verify that the inner lumen of the Microcatheter is compatible with the ERIC Retrieval Device prior to use.

• Verify ERIC Retrieval Device compatibility when using other ancillary devices commonly used in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.

• Use caution when manipulating the ERIC Retrieval Device in tortuous vasculature to avoid damage to the vasculature or the device. Avoid advancing or withdrawal against resistance until the cause of resistance is determined.

• Presence of calcifications, irregularities, or other devices may damage the ERIC Retrieval Device and potentially affect its insertion or removal.

• Maintain saline perfusion between the ERIC Retrieval Device and Microcatheter and Guiding Catheter and Microcatheter to prevent thrombus formation.

• Exposure to angiographic and fluoroscopic X-radiation presents potential risks of alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia that increase in probability as procedure time and number of procedures increase.

• Exercise necessary precautions to limit X-radiation doses to patients and operators by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.