COOK Medical Entuit Gastrostomy BR Mode D'emploi page 3

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
The 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 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. Slide external bolster up and down shaft several times to ensure bolster can be adjusted to properly
secure device when placed.
5. Inflate the 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. Inflate balloon slowly to prevent buildup of
excess pressure in inflation system.
6. Verify balloon integrity by visually inspecting inflated balloon for symmetry and by gently squeezing
the balloon to determine if the balloon is leaking. Balloon symmetry may be improved by gently
manipulating the inflated balloon up and down. Do not use device if any suspected characteristics that
may affect the performance of the balloon are noted.
DEVICE PREPARATION (continued)
7. Deflate balloon by reinserting syringe and removing all water from balloon. Do not attempt to use
device if balloon cannot be deflated.
8. 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.
DEVICE PLACEMENT
Caution: Prior to device placement, a Gastropexy must have been performed to affix the stomach wall to the
abdominal wall, an incision site must be identified for creation of stoma tract, then the stoma must be dilated
and finally measured, in order to ensure patient safety and comfort.
Caution: Confirm that the balloon of the feeding tube will not occlude the Pylorus when inflated, specifically,
when device will be inserted into infants or children.
Warning: Do not attempt to affix the stomach to the abdominal wall using the feeding tube. Excessive
tension, tissue necrosis and inadvertent tube removal may result in separation of the gastric and abdominal
wall.
1. For Device Replacement: Clean stoma site with mild soap and water. Allow area
to dry.
2. Select and prepare the appropriately sized feeding tube in accordance with the "DEVICE PREPARATION"
instructions in the section above.
3. Carefully insert device through the established stoma and into the stomach lumen.
Note: Maintain insertion angle perpendicular to the surface of the skin.
4. Verify that device is inside the stomach lumen using fluoroscopic procedures to determine position
of device using the radiopaque mark located on the tip of the device or by following the instructions
provided in the "VERIFICATION OF TUBE PLACEMENT" section listed below.
5. Inflate the 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.
Inflate balloon slowly to prevent buildup of excess pressure in inflation system.
6. Gently pull device toward abdomen until balloon is up against the inner stomach wall.
7. Slide the external bolster down to the skin.
8. Verify that there is no leakage of gastric contents around the stoma site and that there is not excessive
pressure between the balloon and external bolster.
Warning: Inflating balloon with less volume than the recommended volume may result in leakage of
gastric contents and/or device migration. Inflating balloon with more volume than the recommended
volume may decrease balloon performance.
9. Clean any remaining contents around the stoma site with mild soap and water.
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