PERIVAC™

INDICATIONS:

The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.

CONTRAINDICATIONS:

There are no known contraindications for pericardial aspiration, although recurrent effusion or unresolved cardiac tamponade may warrant surgical intervention.

COMPLICATIONS/RISKS:

Complications and/or risks of pericardiocentesis procedures can include catheter occlusion, infection, cardiac tamponade from puncture, atrial and ventricular arrhythmias, laceration of coronary vessel or chamber wall, air injection into cardiac chambers, pneumothorax, hemothorax, and hypotension (perhaps reflexogenic). Perforation of the stomach, colon, right atrium and/or ventricle is also possible.

WARNINGS:

Rx ONLY Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

• This device is intended for single use only.
• Store in a cool dry place.
• A guide wire should never be advanced or withdrawn against resistance. The cause of the resistance should be determined before continuing.

PRECAUTION:

Pericardiocentesis should only be performed by clinicians well-versed in the technique and aware of its risks and benefits.