The MīAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.
This device is not intended for use except as indicated above.
If the introducer needle is removed from the cannula before placement into the aorta, use caution when reinserting the introducer to prevent cutting or gouging the inner surface of the cannula or tip. Do not reinsert the introducer needle into the cannula once removed after placement into the aorta.
Utilization of this cannula in conjunction with aortic cross clamping for perfusion of the coronary arteries may not result in adequate perfusion of the heart if the aortic valve is incompetent or the coronary arteries have extensive disease and/or occlusions or are anomalous.
Note: Proper surgical procedures and techniques are the responsibility of the medical professional. The described procedure is furnished for information purposes only. Surgeons must evaluate the appropriateness of the procedure based on their own medical training and experience, the type of surgical procedure, and the type of delivery and suction systems utilized.
When infusing cardioplegia solution, use the lowest possible pressures consistent with surgical techniques to minimize hemolysis or damage to the vessels.
When removing the cannula, withdraw it from the aorta before tightening the purse string suture to prevent catching the suture in the side holes or slots of the cannula tip.
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Applicable where phthalates are identified on product label: Due to the presence of phthalates in the product, the clinician must weigh the medical benefits of product use against the drawbacks of phthalate exposure for male children and pregnant or nursing women.
This device, as do all extracorporeal blood system devices, has possible side effects which include, but are not limited to, embolic events and dislocation, infections, blood loss, and thrombus formation. Vessel damage and complications at the puncture site may occur if the Instructions for Use are not followed.
Caution: Additional care and caution may be necessary due to the unique adaptations required for minimally invasive techniques. Care should be taken when inserting the needle to prevent perforation of the back wall of the aorta.
Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures.
Federal law (United States) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions, and warnings, please refer to the instructions for use.
US-CV-2500089 v1.0
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