Product image of the FlexCath Advance™ steerable sheath

4FC12

FlexCath Advance™ Steerable Sheath

The FlexCath Advance™ steerable sheath is used to position an ablation catheter during atrial fibrillation procedures.

Indications, Safety, and WarningsThe FlexCath Advance™ steerable sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.ContraindicationsThe FlexCath Advance™ steerable sheath is contraindicated for placement in the left atrium or ventricle if:

The patient has an intra-atrial septal patch or has had other surgical intervention in or adjacent to the intra-atrial septum.

The patient has had a previous embolic event from the left side of the heart within two months of the procedure.

The patient has known or suspected atrial myxoma.

The sheath should not be used to perform the transseptal puncture.Warnings/precautionsThis is a single-use sheath to be used in a single patient. Do not resterilize this sheath for purpose of reuse. Use this sheath with compatible Medtronic diagnostic and ablations catheters that are 10.5 Fr or smaller. Do not use the sheath if it is kinked or damaged. The sheath and dilator have not been tested for compatibility with transseptal needles. Administer appropriate levels of peri-procedural anticoagulation therapy, during and post-procedure anticoagulation therapy according to patient conditions and institutional standards. Introducing any catheter or sheath into the circulatory system entails the risk of air embolism, which can occlude vessels and lead to tissue infarction with serious consequences. To minimize the risk of air embolism, observe and remove any air prior to introducing the sheath and during the procedure. Remove the guide wire and dilator from the sheath or insert the catheter into the sheath before slowly aspirating and flushing the sheath. Minimize catheter exchanges and always advance and withdraw catheters slowly. Follow advancement or withdrawal of catheters with appropriate aspiration and flushing according to institutional standards or consensus statements. Connect to a continuous drip to minimize back-bleeding. Do not pass the sheath through a prosthetic heart valve (mechanical or tissue). The sheath may become trapped in the valve, damaging the valve and causing valvular insufficiency or premature failure of the prosthetic valve. Cardiac catheterization procedures should be performed only in a fully equipped facility. This sheath should be used only by, or under the supervision of, physicians trained in cardiac catheterization procedures. Use extreme care when manipulating the sheath. Do not use excessive force to advance or withdraw the sheath, especially if resistance is encountered.Potential adverse events or potential complicationsPotential adverse events associated with cannulation of the peripheral vasculature and intracardiac placement of the sheath and dilator may include the following conditions:Access site complications (hematoma, infection, thrombosis, ecchymosis, AV fistula, bleeding from puncture site, hemorrhage); air embolism; arrhythmia (atrial fibrillation, atrial flutter, tachycardia); cardiac arrest; chest discomfort, pain, or pressure; coronary artery spasm, dissection, thrombosis; death; endocarditis; heart block, requiring permanent pacemaker; hemothorax; myocardial infarction; perforation of venous cardiac or surrounding tissue; pericardial effusion, tamponade; pericarditis; pleural effusion; pneumothorax; pseudoaneurysm; pulmonary edema; pulmonary embolism; atroke; thrombus; transient ischemic attack (TIA); vasovagal reaction.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 (United States) restricts this device to sale by or on the order of a physician.MAJ_83945

4FC12

FlexCath Advance™ Steerable Sheath

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4FC12 FlexCath Advance™ Steerable Sheath

Not what you're looking for?

United States

Customer Care Team

4FC12

FlexCath Advance™ Steerable Sheath