INDICATIONS, SAFETY, AND WARNINGS TourGuide Steerable Sheath

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

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions. Failure to properly follow the instructions for use, warnings, and precautions may lead to serious consequences or injury to the patient.


If the indications for use of the device are discussed, the following statement must appear:

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.

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