Halyard MIC, Instructions For Use Manual

3

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* Gastrostomy 

(Fig 1)

 / Bolus Feeding Tube 

(Fig 2)

 allow for 

delivery of enteral nutrition and medication directly into the stomach and/or 

gastric decompression. 

Indications for Use

The HALYARD* MIC* Gastrostomy / Bolus Feeding Tube are indicated for use in 

patients who require long term feeding, are unable to tolerate oral feeding, who 

are at low risk for aspiration, require gastric decompression and / or medication 

delivery directly into the stomach.

Contraindications

Contraindications for placement of a gastrostomy 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 low-profile gastrostomy 

feeding tube:
•  Skin Breakdown
•  Infection
•  Hypergranulation Tissue
•  Stomach or Duodenal Ulcers
•  Intraperitoneal Leakage
•  Pressure Necrosis

Note:

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

compromised.

Placement

The HALYARD* MIC* Gastrostomy / Bolus feeding tubes may be placed surgically, 

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.  

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.

Warning:

The insertion site for infants and children should be high 

on the greater curvature to prevent occlusion of the pylorus when the 

balloon is inflated.

Tube Preparation

1.  Select the appropriate gastrostomy feeding tube, remove from the package 

and inspect for damage.

2.  Using a Luer slip syringe, inflate the balloon with sterile or distilled water 

through the balloon port 

(Fig 1C & 2C)

.

  •   Inflate the balloon with 3-5 ml of sterile or distilled water for low volume 

tubes identified by LV following the REF code number. 

  •   Inflate the balloon with 7-10 ml sterile or distilled water for Standard 

tubes.

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.  Lubricate the tip of the tube with a water soluble lubricant.  Do not use 

mineral oil.  Do not use 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 

appose 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 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.

Note:

For gastrostomy tube placement, the best angle of insertion is a true 

right angle to the surface of the skin.  The needle should be directed toward the 

pylorus if conversion to PEGJ tube is anticipated.

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 J tip guidewire, up to .038”, through the needle and into stomach.  

Confirm position.

6.  Remove the introducer needle, keeping the J tip guidewire in place and 

dispose of according to facility protocol. 

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.  

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.  Select the appropriate gastrostomy feeding tube and prepare according to 

the instructions in the Tube Preparation section above.

2.  Advance the distal end of the tube over the guidewire, through the stoma 

tract and into the stomach.

3.  Verify that the tube is in the stomach, remove the guidewire or peel-away 

sheath if utilized and inflate the balloon.

4.  Using the Luer slip syringe, inflate the balloon.
  •   Inflate the LV balloon with 3-5 ml of sterile or distilled water.  
  •   Inflate the standard balloon with 7-10 ml of sterile or distilled water.
 

Caution:  

Do not exceed 7 ml total balloon volume inside the LV balloon.  

Do not use air.  Do not inject contrast into the balloon.

Caution:  

Do not exceed 15 ml total balloon volume in the Standard 

balloon.  Do not use air.  Do not inject contrast into the balloon.

5.  Gently pull the tube up and away from the abdomen until the balloon 

contacts the inner stomach wall.  

6.  Clean the residual fluid or lubricant from the tube and stoma.
7.  Gently slide the SECUR-LOK* ring to approximately 1-2 mm (approximately 

1/8 inch) above the skin. 

Verify Tube Position and Patency

1.  Attach a catheter tip syringe with 10 ml water to the feeding port.  Aspirate 

gastric contents.  When air or gastric contents are observed, flush the tube.

2.  Check for moisture around the stoma.  If there are signs of gastric leakage, 

check the tube position and SECUR-LOK* ring placement.  Add fluid as 

needed in 1–2 ml increments.  Do not exceed balloon capacity as indicated 

previously.

3.  Begin feeding only after confirmation of proper patency, placement and 

according to physician instructions.

Suggested Endoscopic Placement Procedure

1.  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.

2.  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.

3.  Depress the intended insertion site with a finger.  The endoscopist should 

clearly see the resulting depression on the anterior surface of the gastric 

wall.

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

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.

MIC

*

 Gastrostomy Feeding Tube and 

Bolus Gastrostomy Feeding Tube

 e