EndoVive® Standard PEG

Prescriptive Information

Indications

The initial placement PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

Contraindications

• Patients on anticoagulant drugs
• Obstruction of the esophagus which may prevent the introduction or removal of the feeding tube
• Inability to achieve transabdominal illumination or needle/cannula placement
• Multiple surgical procedures near the gastrostomy site
• High medical risk patients.

Warnings

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

For single patient 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.

After use, dispose of product and packaging in accordance with hospital administrative and/or local government policy.

Precaution

The initial placement PEG kit should not be used on children under 15 kilos/33 pounds.

Potential Adverse Effects

Potential adverse effects may be found in the complete instructions for use.

Please be aware that 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.