Contraindications - Halyard MIC Gebrauchsanweisung

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Figure 1

Diameter

Sterilized by

STERILE R

Gamma Irradiation

Product is NOT made with DEHP

Do not resterilize

Caution

Instructions for Use

Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Description

The HALYARD* MIC* Gastric-Jejunal 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 HALYARD* MIC* Gastric-Jejunal 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 Gastric-Jejunal Feeding Tube include, but are not limited to

ascites, colonic interposition, portal hypertension, peritonitis and morbid obesity.

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 Gastric-Jejunal Feeding Tube:

• Skin Breakdown

• Hypergranulation Tissue

• Intraperitoneal Leakage

Note: Verify package integrity. Do not use if package is damaged or sterile barrier compromised.

Placement

The HALYARD* MIC* Gastric-Jejunal Feeding Tube may be placed percutaneously under

fluoroscopic or endoscopic guidance or as a replacement to an existing device using an

established stoma tract.

Caution: 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.

Caution: 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.

Tube Preparation

1. Select the appropriate size MIC* Gastric-Jejunal Feeding Tube, remove from the package and

inspect for damage.

2. Using the 6 ml Luer slip syringe contained in the kit, inflate the balloon (Fig 1-D) with 5 ml

sterile or distilled water through the balloon port (Fig 1-E).

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. Using a 6 ml Luer slip syringe, flush water through both the gastric (Fig 1-A) and jejunal

ports (Fig 1-B) to verify patency.

5. Lubricate the distal end of the tube with water-soluble lubricant. Do Not Use Mineral Oil Or

Petroleum Jelly.

6. Generously lubricate the jejunal lumen with water-soluble lubricant. Do Not Use Mineral Oil

Or Petroleum Jelly.

Suggested Radiologic Placement Procedure

1. Place the patient in the supine position.

2. Prep and sedate the patient according to clinical protocol.

3. Insure that the left lobe of the liver is not over the fundus or the body of the stomach.

4. Identify the medial edge of the liver by CT scan or ultrasound.

5. Glucagon 0.5 to 1.0 mg IV may be administered to diminish gastric peristalsis.

Caution: Consult Glucagon instructions for use for rate of IV injection and

recommendations for use with insulin dependent patients.

6. Insufflate the stomach with air using a nasogastric catheter, usually 500 to 1,000 ml or until

adequate distention is achieved. It is often necessary to continue air insufflation during the

procedure, especially at the time of needle puncture and tract dilation, to keep the stomach

distended so as to oppose the gastric wall against the anterior abdominal wall.

7. Choose a catheter insertion site in the left sub-costal region, preferably over the lateral

aspect or lateral to the rectus abdominis muscle (N.B. the superior epigastric artery courses

along the medial aspect of the rectus) and directly over the body of the stomach toward the

greater curvature. Using fluoroscopy, choose a location that allows as direct a vertical needle

path as possible. Obtain a cross table lateral view prior to placement of gastrostomy when

interposed colon or small bowel anterior to the stomach is suspected.

Note: PO/NG contrast may be administered the night prior or an enema administered prior to

placement to opacify the transverse colon.

8. Prep and drape according to facility protocol.

Gastropexy Placement

Caution: 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.

Warning: 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

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.

Caution: 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

Single Use Only

Length

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

Do not use if package is damaged

surface.

3. Insert a .038" compatible introducer needle at the center of the gastropexy pattern into the

Rx Only

gastric lumen directed toward the pylorus.

as a plasticizer

Note: 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

Consult instructions for use

verification, a water filled syringe may be attached to the needle hub and air aspirated from

the gastric lumen.

MIC* Gastric-Jejunal Feeding Tube - Endoscopic / Radiologic Placement

• Infection

• Stomach or Duodenal Ulcers

• Pressure Necrosis

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 and leave the guidewire in place.

Dilation

1. Use a #11 scalpel blade to create a small skin incision that extends alongside the guidewire,

downward through the subcutaneous tissue and fascia of the abdominal musculature. After

the incision is made, dispose of according to facility protocol.

2. Advance a dilator over the guidewire and dilate the stoma tract to the desired size.

3. Remove the dilator over the guidewire, leaving the guidewire in place.

Tube Placement

Note: A peel-away sheath may be used to facilitate advancement of the tube through the stoma

tract.

1. Advance the distal end of the tube over the guidewire, through the stoma tract and into the

stomach.

2. Rotate the HALYARD* MIC* Gastric-Jejunal Tube while advancing to facilitate passage of the

tube through the pylorus and into the jejunum.

3. Advance the tube until the tip of the tube is 10–15 cm beyond the Ligament of Treitz and

the balloon is in the stomach.

4. Using a Luer slip syringe, inflate the balloon with 7–10 ml of sterile or distilled water.

Caution: Do not exceed 20 ml total balloon volume. Do not use air. Do not inject

contrast into the balloon.

5. Gently pull the tube up and away from the abdomen until slight tension is felt and the

balloon contacts the inner stomach wall.

6. Gently slide the SECUR-LOK* external retention ring (Fig 1-C) down the tube toward the

abdomen until it rests 2–3 mm above the skin. Do not suture the ring to the skin.

7. Remove the guidewire.

Verify Tube Position

1. Verify proper tube placement radiographically to avoid potential complication (e.g. bowel

irritation or perforation) and ensure the tube is not looped within the stomach or small

bowel.

Note: The jejunal portion of the tube contains tungsten which is radiopaque and can be used

to radiographically confirm position. Do not inject contrast into the balloon.

2. Flush the lumen to verify patency.

3. Check for moisture around the stoma. If there are signs of gastric leakage, check the tube

position and external bolster placement. Add fluid as need in 1–2 ml increments.

Caution: Do not exceed 20 ml total balloon volume.

4. Check to assure that the external bolster is not placed too tightly against the skin and rests

2–3 mm above the abdomen.

5. Document the date, the type, the size and lot number of the tube, the fill volume of

the balloon, skin condition and patient tolerance to the procedure. Start feeding and

medication administration per physician orders and after confirmation of proper tube

placement and patency.

Radiologic Placement Through An Established Gastrostomy Tract

1. Select the appropriate size MIC* Gastric-Jejunal Feeding Tube and prepare according to the

Tube Preparation directions listed above.

2. Under fluoroscopic guidance, insert a floppy-tipped guidewire, up to .038", through the

indwelling gastrostomy tube.

3. Remove the gastrostomy tube over the guidewire.

4. Direct the guidewire through the stoma and coil in the stomach.

5. Advance a .038" guidewire compatible flexible catheter over the guidewire until the

catheter tip is at the pylorus.

6. Negotiate the pylorus and advance the guidewire into the duodenum. If the catheter is

difficult to advance through the pylorus, reduce the length of the catheter coiled in the

stomach. A rotational motion on the flexible catheter may allow easier passage over the

guidewire.

7. Advance the guidewire and catheter to a point 10–15 cm beyond the Ligament of Treitz.

8. Remove the catheter and leave the guidewire in place.

Tube Placement

1. Advance the distal end of the tube over the guidewire and into the stomach.

2. Rotate the HALYARD* MIC* Gastric-Jejunal Tube while advancing to facilitate passage of the

tube through the pylorus and into the jejunum.

3. Advance the tube until the tip of the tube is 10–15 cm beyond the Ligament of Treitz and

the balloon is in the stomach.

4. Using a slip tip syringe, inflate the balloon with 7–10 ml of sterile or distilled water.

Caution: Do not exceed 20 ml total balloon volume. Do not use air. Do not inject

contrast into the balloon.

5. Gently pull the tube up and away from the abdomen until slight tension is felt and the

balloon contacts the inner stomach wall.

6. Gently slide the SECUR-LOK* external retention ring down the tube toward the abdomen

until it rests 2–3 mm (approximately 1/8 inch or thickness of a dime) above the skin. Do not

suture the ring to the skin.

7. Remove the guidewire.

8. Verify proper tube placement according to Verify Tube Position section above.

Suggested Endoscopic Placement Procedure

1. Select the appropriate MIC* Gastric-Jejunal Feeding Tube and prepare according to the Tube

Preparation directions listed above.

2. Perform routine Esophagogastroduodenoscopy (EGD). Once the procedure is complete and

no abnormalities are identified that could pose a contraindication to placement of the tube,

place the patient in the supine position and insufflate the stomach with air.

3. Transilluminate through the anterior abdominal wall to 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. Depress the intended insertion site with a finger. The endoscopist should clearly see the

resulting depression on the anterior surface of the gastric wall.

5. Prep and drape the skin at the selected insertion site.