COOK Medical Biodesign Instrucciones De Uso página 3

BIODESIGN® FISTULA PLUG
INTENDED USE
The Biodesign® Fistula Plug is for implantation to reinforce soft tissue for
repair of recto-vaginal or anorectal fistulas.
The device is supplied sterile and is intended for one time use.
Rx ONLY
This symbol means the following:
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
This symbol means the following: Magnetic Resonance Safe
This product is intended for use by trained medical professionals.
CONTRAINDICATIONS
• This device is derived from a porcine source and should not be used for
patients sensitive to porcine materials.
• Not for vascular use.
PRECAUTIONS
• This device is designed for single use only. Attempts to reprocess,
resterilize, and/or reuse may lead to device failure and/or transmission
of disease.
• Do not resterilize. Discard all open and unused portions.
• Device is sterile if the package is dry, unopened and undamaged. Do not
use if the package seal is broken.
• Discard device if mishandling has caused possible damage or
contamination or if the device is past its expiration date.
• Do not implant the device in a grossly infected or abscessed fistula tract.
• In fistula cases involving evidence of acute inflammation, purulence,
or excessive drainage, a draining seton should be used to allow the
tract to mature and stabilize for six to eight weeks before placing
the plug.
• Ensure that the device is rehydrated prior to placement, cutting,
or suturing.
• Placement of the plug in tracts less than 1cm in length can result in
incomplete incorporation and/or expulsion of the device.
GENERAL
• Users should be familiar with surgical technique for recto-vaginal or
anorectal fistula repair.
• Users should exercise good surgical practice for the management of clean-
contaminated, contaminated or infected fields.
• The potential for infection of the graft material following implantation may
be reduced by cleaning of the fistula tract.
• The Fistula Plug should always be introduced through the rectal (primary)
fistula opening.
• The Fistula Plug should be drawn into the fistula tract completely, until the
button is set against the rectal wall.
• The external/vaginal (secondary) fistula opening should remain open to
allow drainage to occur.
• IMPORTANT: It is recommended that users counsel patients on abstaining
from strenuous physical activity for at least 2 weeks following anorectal
fistula repair, or 6 weeks following recto-vaginal fistula repair. Refer to the
section on Post-Operative Care.
POTENTIAL COMPLICATIONS
Complications that can occur with the Fistula Plug include, but are not
limited to:
• Inflammation
• Migration
• Extrusion
• Infection
• Fistula recurrence
• Incontinence to stool or flatus*
*Note: Reported incontinence rates are very low and are typically temporary
due to the fact that sphincter muscles are not divided. Decreased/
minimal risk of incontinence is generally recognized as a benefit of using
fistula plugs. Fistula plugs have lower reported incontinence rates when
compared to other fistula repair procedures like advancement flaps.
If any of the following conditions occur and cannot be resolved, device
removal should be considered:
• Infection
• Acute or chronic inflammation (Initial application of surgical graft materials
may be associated with transient, mild, localized inflammation)
• Allergic reaction
• Induration
• Erosion
• Seroma formation
• Abscess
• Delayed or failed incorporation of the device
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ENGLISH
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