Required Materials - COOK Medical Biodesign Instrucciones De Uso

STORAGE
This device should be stored in a clean, dry location at room temperature.
STERILIZATION
This device has been sterilized with ethylene oxide and should not
be resterilized.
INSTRUCTIONS FOR USE

REQUIRED MATERIALS

• A sterile dish (kidney dish or other bowl)
• Rehydration fluid: at least 200ml of room temperature sterile saline or
sterile lactated Ringer's solution
• Suitable resorbable suture, such as: 2-0 or 0 polydioxanone (PDO or PDS)
or coated polyglycolic acid suture (coated PGA)
• A short 5Fr catheter
• Hydrogen peroxide or saline for flushing
• 10cc Syringe for flushing
• Cook Fistula Brush for tract debridement
NOTE: Handle device using aseptic technique. Minimize contact with
latex gloves.
PREPARATION
1. Select the proper Fistula Plug size according to PROCEDURAL STEP 6.
2. Remove the packaging containing the Fistula Plug from the box.
3. Remove the inner pouch containing the Fistula Plug from the outer
package using aseptic technique. Place the inner pouch into the
sterile field.
4. Using sterile gloved hands carefully open the inner pouch and remove
the tray containing the Fistula Plug. Place the tray into the sterile field.
5. Open the tray and place the Fistula Plug into a sterile dish using aseptic
technique. Add enough rehydration fluid to the sterile dish to submerge
the Fistula Plug. Allow the Fistula Plug to rehydrate in the sterile dish until
the desired handling characteristics are achieved, but do not allow the
plug to rehydrate any longer than one minute.
NOTE: Rehydrating the plug for more than one minute may lead to
decreased tensile load, which may affect device placement.
6. Carefully remove the hydrated Fistula Plug from the sterile dish
using forceps.
7. Attach a suitable resorbable suture (approximately 30cm in length)
around the narrow end of the Fistula Plug to use as a tether for pulling
the plug into the fistula tract.
NOTE: Bowel preparation and/or rectal enemas are up to the surgeon's
discretion. A single dose of systemic antibiotics is recommended before
the procedure.
2, 3
PROCEDURAL
1. Perform under local, regional, or general anesthesia.
2. If a seton is not already in place, identify the rectal (primary) fistula
opening by inserting a sterile probe into the secondary opening and
navigating it through the fistula tract. Alternatively, inject an appropriate
sterile fluid (hydrogen peroxide or saline) into the secondary opening of
the fistula tract to identify the site of emergence at the primary opening.
NOTE: Failure to locate the rectal opening may lead to persistence of the
fistula. If the rectal opening cannot be reliably identified, an alternative
method of treatment should be considered.
3. If a seton is in place, cut the seton and attach the Cook Fistula Brush to
the seton at the rectal (primary) opening.
4. Pull the Cook Fistula Brush into the fistula tract using a suitable suture
and gently clean/debride the fistula tract to remove non-vascularized
tissue being careful not to enlarge the tract.
NOTE: Bleeding should be noted on the bristles of the Cook Fistula
Brush and at both the primary and secondary openings after
adequate debridement.
5. Flush the tract as thoroughly as possible with hydrogen peroxide or
sterile saline using the10cc syringe and 5Fr catheter.
6. Use a sterile probe or other appropriate measuring instrument to
approximate the diameter of the fistula tract at the primary opening.
Select the proper size of Fistula Plug according to the table below.
Primary Opening Diameter
7. Prepare appropriately sized plug according to instructions in the
preparation section.
(mm)
>1 to 2
>2 to 4
>4 to 7
4
Fistula Plug size
(cm)
0.2 (2mm)
0.4 (4mm)
0.7 (7mm)