Indications, Safety, and Warnings TourGuide Steerable Sheath

Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.

Caution: Federal Law restricts this device to sale by or on the order of a physician (U.S.). Please refer to the Instructions for Use for a complete listing of the indications, contraindications, precautions and warnings, where applicable.

Indications for use

The 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 events

Possible 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 heart beat
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

Precaution

Transvenous device compatibility: Use the steerable sheath only with compatible transvenous devices. Use the appropriate size sheath for the size of the transvenous device being utilized. 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.

Warning

If 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.

FTSOP113326-34 Rev. 1A