12FCC20

Indications, Safety, and WarningsIntended useThe FlexCath Contour™ steerable sheath facilitates introducing various cardiovascular catheters into the heart.Indications for useThe FlexCath Contour™ steerable sheath is indicated for percutaneous catheter, or transseptal needle introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates device positioning.ContraindicationsThe FlexCath Contour™ 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

Compatible catheter sizes:

FlexCath Contour™ steerable device (10 Fr)
The sheath can be used with Medtronic diagnostic and ablation catheter sizes from 7 Fr (2.3 mm) up to 9.5 Fr (3.2 mm).

FlexCath Contour™ steerable device (12 Fr)
The sheath can be used with Medtronic diagnostic and ablation catheter sizes from 7 Fr (2.3 mm) up to 10.5 Fr (3.5 mm).

Warnings/precautions

This is a single-use sheath to be used in a single patient. Do not resterilize this sheath for purpose of reuse.

The dilator is compatible with transseptal needles that are at least 89 cm in length and less than 21 gauge outer diameter.

Do not use the sheath if it is kinked or damaged.

Only physicians trained in left-sided catheterization should use this sheath during transseptal puncture.

Administer appropriate levels of peri-procedural anticoagulation therapy for patients undergoing left-sided, right-sided, and transseptal cardiac procedures.

Administer anticoagulation therapy during and post-procedure 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.

Do not advance the dilator or sheath through the interatrial septum without first confirming left atrial access to prevent advancing these components into an undesired location.

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.

Only physicians trained in left-sided catheterization should use this sheath during transseptal puncture.

Potential adverse events or potential complications

Potential 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 (such as atrial fibrillation, atrial flutter, heart block requiring permanent pacemaker, ventricular tachycardia)

Cardiac arrest

Chest discomfort, pain, or pressure

Coronary artery spasm

Damage to heart tissue or vasculature

Death

Endocarditis

Entrapment of the sheath within the patient

Hemothorax

Latrogenic atrial septal defect (iASD)

Infection (such as pericarditis, sepsis, urinary)

Myocardial infarction

Perforation of venous, cardiac or surrounding tissue

Pericardial effusion, tamponade

Pericarditis

Pleural effusion

Pneumothorax

Pseudoaneurysm

Pulmonary edema

Pulmonary embolism

PV stenosis

Stroke

Thrombus

Transient ischemic attack (TIA)

Valve damage

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 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

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