Indications, Safety, and Warnings
Indications for use
The cannula is intended for use during cardiopulmonary bypass surgery up to six hours or less for the delivery of cardioplegia retrogradely through the coronary sinus.
Contraindications
This device is not intended for use except as indicated above.
Warnings
Extreme caution should be exercised while introducing the catheter into the coronary sinus. Do not force the cannula into the coronary sinus as this may cause vessel damage.
Do not use liquid to inflate the balloon on the 6-Fr models. Due to the incompressibility of liquids, overdistention of the coronary sinus may occur. Only air should be used to inflate the balloon. On the 6-Fr models do not exceed an inflation volume of 2 cc of air as distal balloon and/or coronary sinus damage may occur.
DO NOT OVERINFLATE THE BALLOON. Overinflation may cause coronary sinus injury. Typically, a volume of 1 cc to 2 cc (6-Fr model), 1 cc to 3 cc (10-Fr model), 3 cc to 5 cc (13-Fr and 15-Fr models), or 3 cc to 8 cc (elongated balloon models) of air is sufficient. The actual volume needed may vary as a function of cannula placement and coronary sinus anatomy. (Saline may be used, with all but the 6-Fr models , but may require slightly less volume to effect a seal due to its incompressible nature.) Adequacy of balloon inflation and position should be confirmed manually or visually prior to cardioplegia administration and as evidenced by a pressure wave through the pressure monitoring port.
The pressure within the coronary sinus should be monitored while administering the cardioplegia. DO NOT EXCEED 50 mmHg SINUS PRESSURE.
Precautions
Note: Proper surgical procedures and technique 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, and the type of surgical procedure being performed.
Do not exceed recommended balloon inflation volume or recommended sinus pressure within the coronary sinus.
Do not inflate the balloon until it has been properly placed within the coronary sinus.
Squeezing the blue sentinel balloon on the 6-Fr models will further inflate the distal balloon and increase its diameter. Caution should be used not to overextend an already inflated distal balloon by inadvertently compressing the blue sentinel balloon on the 6-Fr models.
Balloon should be completely evacuated before insertion.
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.
Adverse effects
This device, as do all extracorporeal blood system devices, has possible side effects which include, but are not limited to, infections, blood loss, thrombus formation, embolic events, and dislocation. Vessel damage and complications at the puncture site may occur if the Instructions for Use are not followed.
Important safety information
Extreme caution should be exercised while introducing the cannula into the coronary sinus. Do not force the cannula into the coronary sinus as this may cause vessel damage. Do not overinflate the balloon. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use.
Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.
US-CV-2500090 v1.0
