PeritX™ Peritoneal Catheter System

Indications for Use: 

The PeritX™ Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.

The use of the PeritX™ Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.

The Lockable Drainage Line (Figure 2) is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

Contraindications: 

Use of the PeritX™ Peritoneal Catheter System is contraindicated in the following situations:

1. When the peritoneal cavity is multi-loculated, and the drainage of a single loculation would not be expected to provide relief of dyspnea or other symptoms.

2. When there is a coagulopathy

3. When the peritoneal cavity is infected.

4. When the patient is known or suspected to be allergic to materials contained in the device.

The valved peel-away introducer and catheter insertion stylet are not designed for use in the arterial system or as a hemostatic device.

Warnings: 

Do not put anything except the access tip of the Lockable Drainage Line, Catheter Access Kit, or PleurX™ Vacuum Bottles into the catheter valve since any other device could damage the valve. A damaged valve may allow air into the body or let fluid leak out through the valve when not draining.

A diagnostic paracentesis should be performed if the patient shows signs or symptoms of possible spontaneous bacterial peritonitis (SBP) such as fever or abdominal pain. If SBP is present, the patient should be treated per institutional guidelines, including systemic antibiotics and repeat diagnostic paracentesis at the end of the antibiotic regimen. For a patient with resolved SBP, the patient should be treated per institutional guidelines, including prophylactic antibiotics to help in the prevention of refractory or recurrent SBP. In the case of refractory or recurrent infections, the catheter should be removed and reinserted at the discretion of the clinician after the SBP has resolved.

Do not place the PeritX™ Peritoneal Catheter into the pleural space as it could lead to misidentification of the catheter and/or mistreatment of the patient.

Cautions

For single use only. Re-use may result in a nonfunctional product or contribute to cross contamination.

Sterile technique should be used when placing and draining the catheter.

Care must be taken not to bend or kink the sheath.

Damage to the sheath may prevent passage of the catheter.

The fenestrations must be entirely within the peritoneal space to avoid leakage into the tunnel tract. Take patient size, tunnel length, and the catheter length into account when placing the catheter.

The valved peel-away introducer is designed to reduce fluid loss and the risk of air intake, but is not a hemostasis valve. It is not intended to create a two-way seal, nor for arterial use. It will substantially reduce the race of fluid flow, but some fluid loss through the valved peel-away introducer may occur.

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions, and information for use.

BD-131803