5843 | Medtronic

Product image of the Soft-Flow™ arterial cannula

Indications, Safety, and WarningsIndicationsSoft-Flow® Extended Aortic Cannula are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours.ContraindicationsThis device is not designed, sold, or intended for use except as indicated.Cautions and WarningsProper surgical procedures and techniques are the responsibility of the medical professional.These devices are designed for use in cardiovascular surgery by trained surgeons. Positionable suture ring must remain exterior to the heart and all vessels. Do not insert the suture ring into the heart or any vessels. Inaccurate placement or unintended migration of the cannula can lead to cerebral hypoperfusion, severe ischemic injury, and/or death.Sterile and non-pyrogenic unless package is opened or damaged. Only clamp on the clear tube as shown in the diagram. Do not clamp on the reinforced tubing areas or connector. Do not use if package is damaged. Adequate anticoagulation is required.PhthalatesThis device contains phthalates. Based on animal studies, significant exposure to phthalates may interfere with the normal development of the male reproductive tract. For children, pregnant and nursing women, alternative devices may be appropriate.Single UseFor single use only. Do not reuse. Do not re-sterilize. Do not reprocess. Reprocessing may compromise the sterility, biocompatibility, and functional integrity of the device.Adverse EffectsCardiopulmonary bypass surgery includes clinical risks of adverse effects such as hemolysis, gas embolism, thrombosis, inadequate perfusion, and device problems (leaks, component breaks, kinked tubing that reduces blood flow, foreign matter/particulates, and vessel injury due to surface irregularities or unintended location during device insertion/removal) which may cause injury or death.Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgery procedures.  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-2500131 v1.0

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