avanos MIC Mode D'emploi page 2

AVANOS* MIC Gastric-Jejunal Feeding Tube (GJ-Tube)
*
• e n
with ENFit
Connectors • Endoscopic / Radiologic Placement
®
Fig 1
E
Instructions for Use
Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Description
The AVANOS* MIC* Gastric-Jejunal (GJ) Feeding Tube (Fig. 1) provides for simultaneous gastric decompression/drainage
and delivery of enteral nutrition into the distal duodenum or proximal jejunum.
Indications for Use
The AVANOS* MIC* GJ Feeding Tube is indicated for use in patients who cannot absorb adequate nutrition through the
stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of
aspiration, or in those who have had previous esophagectomy or gastrectomy.
Contraindications
Contraindications for placement of a GJ feeding tube include, but are not
limited to:
• Colonic interposition
• Ascites
• Portal hypertension
• Peritonitis
• Uncorrected coagulopathy
• Uncertainty as to gastrostomy tract direction and length (abdominal wall thickness)
• Lack of adherence of the stomach to the abdominal wall (replacement only)
• Lack of established gastrostomy tract (replacement only)
• Evidence of infection around stoma site (replacement only)
• Presence of multiple stoma fistulous tracts (replacement only)
Warning
Do not reuse, reprocess, or resterilize this medical device. Reuse, reprocessing, or resterilization may 1)
adversely affect the known biocompatibility characteristics of the device, 2) compromise the structural integrity
of the device, 3) lead to the device not performing as intended, or 4) create a risk of contamination and cause
the transmission of infectious diseases resulting in patient injury, illness, or death.
Complications
The following complications may be associated with any GJ feeding tube:
• Nausea, vomiting, abdominal bloating or diarrhea
• Aspiration
• Peristomal pain
• Abscess, wound infection and skin breakdown
• Pressure necrosis
• Hypergranulation tissue
• Intraperitoneal leakage
• Buried bumper syndrome
• Peristomal leakage
• Balloon failure or tube dislodgement
• Tube clog
• Gastrointestinal bleeding and/or ulceration
• Gastric outlet obstruction
• Ileus or gastroparesis
• Bowel and gastric volvulus
Other complications such as abdominal organ injury may be associated with the procedure to place the feeding tube.
Placement
This AVANOS* GJ Feeding Tube may be placed in the following ways:
Percutaneously under fluoroscopic (radiologic) guidance
Percutaneously under endoscopic guidance
A replacement to an existing device using an established stoma tract
Warning. A gastropexy must be performed to affix the stomach to the anterior abdominal wall, the feeding
tube insertion site identified and stoma tract dilated prior to initial tube insertion to ensure patient safety and
comfort. The length of the tube should be sufficient to be placed 10–15 cm beyond the Ligament of Treitz.
Warning. Do not use the retention balloon of the feeding tube as a gastropexy device. The balloon may burst
and fail to attach the stomach to the anterior abdominal wall.
2
Jejunal
C
D
B
Jejunal
A
Tube Preparation
Warning. Verify package integrity. Do not use if package is damaged or sterile barrier compromised.
1. Select the appropriate size MIC* GJ Feeding Tube, remove from the package and inspect for damage.
2. Using the male Luer syringe contained in the kit, inflate the balloon (Fig. 1-E) with water through the Balloon Inflation
Port (Fig 1-A). Do not use air.
3. Remove the syringe and verify balloon integrity by gently squeezing the balloon to check for leaks. Visually inspect the
balloon to verify symmetry. Symmetry may be achieved by gently rolling the balloon between the fingers. Reinsert the
syringe and remove all the water from the balloon.
4. Check the external retention bolster (Fig. 1-D). The bolster should slide along the tube with moderate resistance.
5. Inspect the entire length of the tube for any irregularities.
6. Using an ENFit® syringe, flush both the gastric lumen (Fig. 1-C) and jejunal lumen (Fig. 1-B) of the tube with water to
confirm tube patency.
7. Lubricate the tip of the tube with a water soluble lubricant. Do not use mineral oil. Do not use petroleum jelly.
8. Generously lubricate the jejunal lumen with water-soluble lubricant. Do not use mineral oil. Do not use petroleum jelly.
Suggested Site Preparation
1. Use standard Radiologic or Endoscopic techniques to visualize and prepare for GJ tube placement.
2. Verify that no abnormalities are present that could pose a contraindication to placement of the tube and place the patient
in the supine position.
3. Select a gastrostomy site that is free of major vessels, viscera, and scar tissue. The site is usually one third the distance
from the umbilicus to the left costal margin at the midclavicular line.
4. Prep and drape the selected insertion site per facility protocol.
Gastropexy Placement
Warning: It is recommended to perform a three point gastropexy in a triangle configuration to ensure
attachment of the gastric wall to the anterior abdominal wall.
1. Place a skin mark at the tube insertion site. Define the gastropexy pattern by placing three skin marks equidistant from
the tube insertion site and in a triangle configuration.
Caution. Allow adequate distance between the insertion site and gastropexy placement to prevent interference of
the T-Fastener and inflated balloon.
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia to the skin and peritoneum.
3. Place the first T-Fastener and confirm intragastric position. Repeat the procedure until all three T-Fasteners are inserted
at the corners of the triangle.
4. Secure the stomach to the anterior abdominal wall and complete the procedure.
Create the Stoma Tract under Fluoroscopic (Radiologic) Visualization
1. Create the stoma tract with the stomach still insufflated and in apposition to the abdominal wall. Identify the puncture
site at the center of the gastropexy pattern. With fluoroscopic guidance, confirm that the site overlies the distal body of
the stomach below the costal margin and above the transverse colon.
Warning. Avoid the epigastric artery that courses at the junction of the medial two-thirds and lateral
one-third of the rectus muscle.
Warning. Take care not to advance the puncture needle too deeply in order to avoid puncturing the
posterior gastric wall, pancreas, left kidney, aorta or spleen.
2. Anesthetize the puncture site with local injection of 1% lidocaine down to the peritoneal surface.
3. Insert a .038" compatible introducer needle at the center of the gastropexy pattern into the gastric lumen directed
toward the pylorus.
Note. For GJ tube placement, the best angle of insertion is a 45 degree angle to the surface of the skin.
4. Use fluoroscopic visualization to verify correct needle placement. Additionally, to aid in verification, a water filled syringe
may be attached to the needle hub and air aspirated from the gastric lumen.
Note. Contrast may be injected upon return of air to visualize gastric folds and confirm position.
5. Advance a guidewire, up to .038", through the needle and coil in the fundus of the stomach. Confirm position.
6. Remove the introducer needle, leaving the guidewire in place, and dispose of according to facility protocol.
7. Advance a .038" compatible flexible catheter over the guidewire and using fluoroscopic guidance, manipulate the
guidewire into the antrum of the stomach.
8. Advance the guidewire and flexible catheter until the catheter tip is at the pylorus.
9. Negotiate through the pylorus and advance the guidewire and catheter into the duodenum and 10–15 cm beyond the
Ligament of Treitz.
10. Remove the catheter, leaving the guidewire in place, and dispose of according to facility protocol.
Create the Stoma Tract under Endoscopic Visualization
1. Create the stoma tract with the stomach still insufflated and in apposition to the abdominal wall. Identify the puncture
site at the center of the gastropexy pattern. With endoscopic guidance, confirm that the site overlies the distal body of
the stomach below the costal margin and above the transverse colon.
Warning. Avoid the epigastric artery that courses at the junction of the medial two-thirds and lateral
one-third of the rectus muscle.
Warning. Take care not to advance the puncture needle too deeply in order to avoid puncturing the
posterior gastric wall, pancreas, left kidney, aorta or spleen.
2. Anesthetize the puncture site with local injection of 1% lidocaine down to the peritoneal surface.
3. Insert a .038" compatible introducer needle at the center of the gastropexy pattern into the gastric lumen directed
toward the pylorus.
Note. For GJ tube placement, the best angle of insertion is a 45 degree angle to the surface of the skin.
4. Use endoscopic visualization to verify correct needle placement.
5. Advance a guidewire, up to .038", through the needle and into the stomach. Confirm position.
6. Use endoscopic visualization to grasp the guidewire with atraumatic forceps.
7. Remove the introducer needle, leaving the guidewire in place, and dispose of according to facility protocol.