Injection Gold Probe™ Hemostasis Catheter

Prescriptive Information

Indications

The Injection Gold Probe Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: peptic ulcers, dieulafoy lesions, Mallory-Weiss tears, bleeding polyp staulks, arteriovenous malformations (AVMs), and angiomata.

The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.

Contraindications

Contraindications for this device are those specific to injection therapy and bipolar electrohemostasis treatments. These contraindications include, but are not limited to: non-focal bleeding sites, esophageal/gastric varices, diffuse lesions and allergies to injection agents.

Warnings

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 a patient.

The Injection Gold Probe Catheter is supplied sterile by method of Ethylene Oxide. If the catheter package is open or damaged, do not use or resterilize the device.

Potential Adverse Events

Potential adverse events may include, but are not limited to: perforation, bleeding, post-injection ulceration with delayed bleeding, aspiration pneumonia, pleural effusion, other respiratory difficulties, hepatic failure, septicemia/infection, chest pain, esophageal ulcers, and esophageal strictures.

Please be aware that potential adverse events 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

A thorough understanding of the technical principles, clinical application, and risks associated with bipolar electrohemostasis and injection therapy is necessary before using this product.

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.