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Indications, Safety, and WarningsIndicationsThe FlexCath Cross Transseptal Solution is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.ContraindicationsMyocardial infarction within the last two weeks; patients with: an active infection, atrial thrombus, known or suspected atrial myxoma; patients that have experienced: a recent cerebrovascular accident (CVA) or unstable angina; patients who do not tolerate anticoagulation therapy; or patients with an interatrial septal patchWarnings and PrecautionsRead the instructions for use before using this device to mitigate the risks and potential complications associated with use of the device. This is a single-use device only and is not intended for use in children, or in pregnant or nursing patients. Only physicians fully trained in cardiac transseptal catheterization procedures should use this device and patient’s hemodynamic/physiologic parameters should be monitored.Potential Adverse Events or Potential ComplicationsPotential adverse include, but are not limited to: Access site complications (hematoma, infection, thrombosis, ecchymosis, AV fistula, pseudoaneurysm, bleeding from puncture site, hemorrhage); Air embolism; Arrhythmias; Artery or venous dissection; Artery spasm and/or damage; Cardiac tamponade; Cerebral infarct; Chest pain / discomfort; Dissection; Femoral vein injury; Heart block; Hemothorax; Infection/sepsis; Myocardial infarction; Obstruction or perforation or damage to vascular system; Pacemaker/defibrillator lead displacement; Pericardial effusion or tamponade; Pulmonary edema; Tear in the vascular intima; Thromboembolism; Transient ischemic attack (TIA); Vascular bleeding; Vasovagal reaction; Radiation exposure events.Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.Caution: Federal law (USA) restricts the devices to sale by or on the order of a physician.US-ACI-2500014 v1.0

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