Device Preparation; How Supplied; Handling And Storage - COOK Medical Enluit Thrive Instrucciones De Uso

COMPLICATIONS/ADVERSE EVENTS
Complications and adverse events associated with placement and use of a balloon
gastrostomy tube include, but are not limited to:
• Aspiration, reflux, sepsis, ascites, bleeding, peritonitis and perforation
• Granulation tissue, pressure necrosis and ulcers
• Irritation and infection such as redness, edema or purulent drainage
• Severe gastroesophageal reflux or diffuse inflammatory, infectious, or neoplastic
disease involving the walls of the abdomen or anterior stomach
• Gastrointestinal obstruction and proximal small bowel fistulae
• Tube clogging, kinking, malposition, migration, leakage and unintended tube
dislodgement.

HOW SUPPLIED

Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is provided sterile with
one (1) Instructions for Use for each device.

HANDLING AND STORAGE

Store in a cool, dry, and secure environment to prevent damage.

DEVICE PREPARATION

Warning:An inappropriately sized tube may cause leakage of gastric contents,
necrosis, granulation tissue, sepsis, associated sequelae and/or buried bumper
syndrome.
1. Select the appropriately sized Entuit™ Thrive Balloon Retention Gastrostomy
Feeding Tube based on the diameter of patient's stoma.
2. Inspect package integrity before use. Do not use device if package is damaged or if
the sterile barrier has been compromised.
3. Remove device from package and inspect contents for damage. Do not use
contents if damaged.
4. Inflate the Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube balloon to
recommended fill volume (printed on the device) with sterile or distilled water using a
sterile syringe.
Caution:Only use sterile or distilled water for balloon inflation. Do not use air,
saline, feeding formula, medication, or radiopaque contrast for balloon inflation.
5. Verify balloon integrity by visually inspecting inflated balloon for symmetry and by
gently squeezing the balloon to determine if the balloon is leaking. Do not use
device if any suspected characteristics that may affect the performance of the
balloon are noted.
6. Deflate balloon by reinserting syringe and removing all water from balloon. Do not
attempt to use device if balloon cannot be deflated.
7. If necessary, lubricate the tip of the device with a water soluble lubricant for ease of
insertion. Sterile gauze pads may be used for ease of tip lubrication.
Note:Do not use petroleum jelly or mineral oil for tip lubrication.
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