
The described procedure is furnished for informational purposes only. Note: Proper surgical procedures and techniques are necessarily the responsibility of the medical professional.Check for any possible obstructions in the shunt's internal lumen before placing the shunt in the artery.The shunt is not an implantable device and may only be used temporarily as described in the “Indications” above.Modifying the x-ray angle or distance may aid in detection. In some cases, shunts may not be detectable by x-ray due to the variances in anatomical densities and x-ray techniques.Attempt to force the shunt’s tips past any vessel obstructions.Damage the intima of the coronary artery during product use.Damage or scratch the shunt prior to insertion into the coronary artery.These shunts are not intended for use except as indicated above.These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.Applicable where phthalates are identified on the 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.Reuse, reprocessing, or re-sterilization 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. Do not reuse, reprocess, or re-sterilize this product. This device was designed for single patient use only.Release compressed CO2/medical air in a controlled fashion, by pointing the tip of device away from the wound or surgical site before turning the device on.The shunt, tether, and tag should remain intact.Use only PVC tubing to connect the airline to the device.Each surgeon must, of course, evaluate the appropriateness of the procedure based on their own medical training and experience, and the type of surgical procedure. The described procedure is furnished for information purposes only.

