EndoVive® Low Profile PEG

Prescriptive Information

Indications

Intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

Contraindications

• Children under 10 Kilos/22 pounds
• The 24Fr is not indicated in children under 15 Kilos/33 pounds
• Individuals with abnormally high intra-abdominal pressures
• Obstruction of the esophagus, which may prevent the introduction or removal of the feeding tube
• Inability to identify transabdominal illumination or needle placement
• Multiple surgical procedures near the gastrostomy site
• Patients on anticoagulant drugs
• High medical risk patients

Warnings

Contents supplied STERILE using an (ethylene oxide (EO)/Radiation) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.

For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Potential Adverse Effects

The following potential adverse effects may occur with the use of direct feeding devices:

• Fever
• Gastric distention
• Infection
• Blockage
• Tissue necrosis

Please be aware that the potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions

Cautions can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.