TG0855517

TourGuide™ steerable sheath shown vertically

Indications, Safety, and WarningsNote: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details.Indications for useThe steerable sheath, model TourGuide™ is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal, or other peripheral placements. Do not use this device for neural placements.Contraindications

Known active or systemic local infection

Known inability to obtain vascular access

Patients with atrial thrombosis or myxoma, or interatrial baffle or patch

Use of a steerable sheath is contraindicated in patients with obstructive or inadequate vasculature

Potential adverse eventsPossible adverse events associated with the use of TourGuide™ steerable sheath include, but are not limited to:

Air embolism

Allergic reaction to contrast media

Aortic puncture

Arrhythmias

Arteriovenous fistula formation

Atrial septal defect

Bleeding plexus injury

Catheter entrapment

Cardiac tamponade

Coronary artery spasm and/or damage

Dislodgement

Dissection

Endocarditis

Heart block

Hematoma formation

Hemorrhage

Hemothorax

Infection

Intimal tear

Irregular heartbeat

Local nerve damage

Mediastinal widening

Myocardial infarction

Pacemaker/defibrillator lead displacement

Perforation

Pericardial/pleural effusion

Pneumothorax

Pseudoaneurysm formation

Pulmonary edema

Stroke

Subclavian artery puncture

Thromboembolic events

Thrombophlebitis

Valve damage

Vascular occlusion

Vasovagal reaction

Vessel damage/vessel trauma

Vessel spasm

PrecautionsTransvenous device compatibility: Use the steerable sheath only with compatible transvenous devices. Use the appropriate size sheath for the size of the transvenous device being used. Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.ShapeWarningsIf the patient has left bundle branch block, back up pacing should be readily available during insertion of the steerable sheath assembly. Use of the steerable sheath assembly may cause heart block.Caution: Federal Law (United States) restricts this device to sale by or on the order of a physician. Refer to the instructions for use for a complete listing of the indications, contraindications, precautions, and warnings where applicable.FTSOP113326-34 Rev. 1A

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