Hemospray® Endoscopic Hemostat Animation

This step-by-step animation provides an overview of how to deploy Hemospray to treat nonvariceal gastrointestinal bleeds. For more information on this device please visit https://hemospray.cookmedical.com

Hemospray® Endoscopic Hemostat

INSTRUCTIONS FOR USE (IFU)
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MORE INFO
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INTENDED USE
This device is used for hemostasis of nonvariceal gastrointestinal bleeding.
NOTE: HEMOSPRAY INTENDED USE IS NOT THE SAME FOR ALL REGIONS.

NOTES
Do not use this device for any purpose other than stated intended use.
Store in a dry location, away from temperature extremes.
Use of this device is restricted to a trained healthcare professional.

DEVICE DESCRIPTION
Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the site of the bleed. Each device contains approximately 20g of powder.

CONTRAINDICATIONS
Those specific to primary endoscopic procedure to be performed in gaining access to desired target site. Also contraindicated in patients who have gastrointestinal fistulas, are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment.

WARNINGS
Keep catheter tip at least 1 cm away from bleeding site to minimize risk of embolization.

Hemospray has not been approved for use in pediatric populations, no safety or effectiveness data exists and would be considered off-label usage, to do so is at the professional risk of the surgeon/healthcare professional.

Patients with gastrointestinal bleeding that are on antithrombotic medication may be at an increased risk of rebleeding. Follow the relevant clinical guidelines for management of antithrombotic agents for endoscopic procedures.

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

If package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working conditions, do not use. Please notify Cook for return authorization.

PRECAUTIONS
For best results, Hemospray must be delivered to the source of bleeding.

Ensure gastrointestinal lumen is not distended because Hemospray adds volume in excess of insufflation volumes during procedure. Closely monitor bowel distension and balance insufflation and Hemospray volumes as necessary.

Use of more than (3) Hemospray devices per patient may result in impaction in colon and is not recommended.

Product contains 16 g CO2 cartridge. Contents under pressure. Do not puncture or heat above 120° F/ 49° C. Do not inhale or discharge towards face/body. Keep CO2 dispenser and cartridge out of reach of children.

Hemospray is inert and non-toxic.

As a granular material, unintentional exposure to the powder may cause potential irritation to the skin, eyes and lungs.

In the event of unintended exposure to the powder refer to the following First Aid measures:

Skin: Wash with soap and water until clean. Eyes: Flush with water until irritation ceases.

Inhalation: Move to area free from powder. If symptoms of irritation persist, contact physician. Inhalation may aggravate existing respiratory illness.

Refer to package label for minimum channel size required for this device.

All endoscopic hemostatic therapies, including Hemospray, have an associated risk of rebleeding, particularly in situations where the cause of bleeding is an unresolved underlying disease. After hemostasis has been achieved, monitor patients for rebleeding per the relevant Clinical Guidelines.

Although not seen in clinical practice, there remains a theoretical risk of aspiration of Hemospray powder resulting in respiratory complications. It is prudent to restrict the use of Hemospray to 5 cm below the UES.

PROCEDURAL PRECAUTIONS
Like other modalities, Hemospray may not be effective for all types of bleeds. Gastrointestinal bleeding may exacerbate existing comorbidities, increasing the potential for adverse events including patient mortality.