EndoVive® Safety PEG

Prescriptive Information

Indications

The Safety PEG is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.

Contraindications

• Patients on anticoagulant drugs with abnormal clotting parameters
• Obstruction of the esophagus which may prevent the introduction or removal of the feeding tube
• Inability to identify transabdominal illumination or needle/cannula placement
• Patients that have undergone prior surgery that could adversely impact the PEG placement
• 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 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. Precautions may be found in the complete instructions for use.

Potential Adverse Effects

Potential adverse effects can 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.