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Indications, Safety and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE

The steerable sheath, model DIREX™ is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

CONTRAINDICATIONS

  • Known active systemic or local infection
  • Known inability to obtain vascular access
  • Patients with atrial thrombus or myxoma, or interatrial baffle or patch
  • Use of a steerable sheath is contraindicated in patients with obstructed or inadequate vasculature

PRECAUTIONS

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.

ADVERSE EVENTS

Potential adverse effects related to the use of the 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

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