DIREX™

Indications, Safety and Warnings

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

EP-1315904-AA

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