NHS03

A product image of the Nexpowder™* endoscopic hemostasis system

Indications, Safety, and WarningsIndicationsNexpowder™* is used for hemostasis of nonvariceal gastrointestinal bleeding.Note: Do not use this device for any purpose other than the stated intended use.Contraindications

Because Nexpowder™* includes lactose, this device is contraindicated in patients who have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and they would be at risk of having nausea, bloating, and diarrhea.

Because Nexpowder™* includes Brilliant Blue FCF, the device must not be used in patients with known hypersensitivity to Brilliant Blue FCF.

Nexpowder™ is contraindicated for patients with suspected bowel obstruction, gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.

Potential complicationsThose associated with gastrointestinal endoscopy include, but are not limited to: hemorrhage, perforation, aspiration, fever, infection, allergic reaction, cardiopulmonary events, abdominal pain or discomfort, post-polypectomy syndrome, pancreatitis (with ERCP), esophageal or gastric strictures, delayed complications, sedation-related complication and foreign body sensation in the digestive tract. Nexpowder™* may occlude ducts and orifices which communicate with the main bowel lumen causing infection or obstruction. Use caution when using Nexpowder™* in the vicinity of these orifices.Warnings

Precautions in the instructions for use must be followed to minimize the risk of catheter clogging and device malfunction.
    - Turn on the power of spray body before inserting the catheter through a working channel.
    - Do not aspirate while catheter is in the accessory channel.
    - Do not place the catheter directly in contact with any fluids.
    - Catheter tip should be approximately 1 to 2 cm away from the bleeding site.

Nexpowder™ has not been approved for use in pregnant women, nursing mothers and pediatric population and there is no safety or efficacy data in these groups.

Patients that are on antithrombotic medication may be at an increased risk of re-bleeding. Take individual patient needs and relevant clinical guidelines into account when managing antithrombotic agents for endoscopic procedures. Consider consulting the physician responsible for the antithrombotic if needed.

This medical device is designed for single use only. Attempts to resterilize and/or reuse may lead to device failure and/or transmission of disease.

Use of Nexpowder™* in the presence of bowel obstruction, ileus, and/or an anastomosis may pose a risk of injury due to over-distention.

Nexpowder™* may occlude ducts and orifices which communicate with the main bowel lumen. Use caution when using Nexpowder™* in the vicinity of these orifices including diverticula.

Although not seen in clinical practice, there is a risk of aspiration of Nexpowder™*, resulting in respiratory complications. It is prudent to restrict the use of Nexpowder™* to 5 cm below the upper esophageal sphincter (UES).

Although not seen in clinical practice, powder impaction in colon may cause bowel obstruction or ischemic injury.

TM* Third party brands are trademarks of their respective owners.

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