Contents; Materials Of Animal Origin; Intended Use; Indications For Use - Boston Scientific AMS 800 Mode D'emploi

Contents

The following is a list of the AMS 800 AUS components and accessories.
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(1) Occlusive Cuff
(1) Control Pump
(1) Pressure Regulating Balloon
(1) AMS 800 Artificial Urinary Sphincter Accessory Kit:
(3) Straight Quick Connect Window Connectors
(2) Right Angle Quick Connect Window Connectors
(1) Y Quick Connect Window Connector
(3) Straight Suture-Tie Connectors
(2) Right Angle Suture-Tie Connectors
(1) Y Suture-Tie Connector
(8) Collets
(1) Collet Holder
(1) Cuff Sizer
(2) 22 gauge Blunt Tip Needles
(2) 15 gauge Blunt Tip Needles
(2) 30 cm lengths of tubing

Materials of Animal Origin

The following components of the AMS 800 Artificial Urinary Sphincter contain materials
of animal origin:
• InhibiZone treated components may contain a non-viable derivative of porcine
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origin or a bovine milk derivative.
• The Quick Connect Window Connectors and the collets contain a non-viable tallow
derivative.

INTENDED USE

The AMS 800 AUS inflated cuff applies circumferential pressure on the urethra to
increase urethral resistance to urinary flow.

INDICATIONS FOR USE

The AMS 800 AUS is used to treat urinary incontinence due to reduced urethral/bladder
outlet resistance (intrinsic sphincter deficiency) in males and females.

CONTRAINDICATIONS

• This device is contraindicated in patients whom the physician determines to be
poor candidates for surgical procedures and/or anesthesia due to physical or
mental conditions.
• This device is contraindicated in patients with urinary incontinence due to or
complicated by an irreversibly obstructed lower urinary tract.
• This device is contraindicated in patients with irresolvable detrusor hyperreflexia or
bladder instability.
• The implantation of the InhibiZone version of this device is contraindicated in
patients with known allergy or sensitivity to rifampin or to minocycline HCl or other
tetracyclines.
• The implantation of products with InhibiZone is contraindicated in patients with
systemic lupus erythematosus because minocycline HCl has been reported to
aggravate this condition.

WARNINGS

Surgery-Related
• Erosion may be caused by infection, pressure on the tissue, improper cuff sizing,
improper balloon selection, tissue damage, and component malposition. Failure
to evaluate and promptly treat erosion may result in substantial worsening of the
condition, leading to infection and/or loss of tissue.
• The implanter should check that there is an adequate amount of bulbospongiosus
muscle to surround and support a bulbous urethral cuff implant. Thinner
spongiosum typically occurs toward the distal end of the bulbous urethra, and
implantation of the cuff where the spongiosum is thin increases the chance of
erosion and other complications. This warning is especially important for double
cuff implants, where the second cuff is placed distal to the first implanted cuff.
Patient-Related
• Patients with urinary tract infections, diabetes, spinal cord injuries, open sores,
or skin infections in the region of the surgery have an increased risk of infection
associated with a prosthesis. Appropriate measures should be taken to reduce the
likelihood of infection. Infection that fails to respond to antibiotic therapy may result
in removal of the prosthesis. Infection followed by explantation of the device may
result in scarring which may make subsequent reimplantation more difficult.
• Poor bladder compliance or a small, fibrotic bladder may require some measure of
intervention including, in some cases, augmentation cystoplasty before implanting
the prosthesis.
• Patients with urge incontinence, overflow incontinence, detrusor hyperreflexia, or
bladder instability should have these conditions treated and controlled (or resolved)
prior to implantation of the device.
• This device contains solid silicone elastomers. The risks and benefits of implanting
this device in patients with documented sensitivity to silicone should be carefully
considered.
• Previous patient history of an adverse reaction to any radiopaque solution
precludes their use as a filling medium for the prosthesis. Instead, sterile normal
saline should be used to fill the device.
Post-Procedural
• Do not pass a catheter or any other instrument through the urethra without first
deflating the cuff and deactivating the device, to prevent potential damage to the
urethra or the AMS 800 AUS.
• Adequate manual dexterity, strength, motivation, and mental acuity are required
for proper use of the device. Surgical complications, or physical or psychological
complications (such as any progressively degenerative disease), if they occur,
may affect the use of the system. Continued improper use may lead to revision or
removal of the prosthesis. Removal of the device without timely reimplantation
of a new device may complicate subsequent reimplantation. The timing of
reimplantation should be determined by the treating physician based on the
patient's medical condition and history.
• Any mechanical malfunction that does not permit the transfer of fluid from the
cuff to the balloon may result in outflow obstruction. Mechanical events should be
evaluated carefully by the treating physician, and the patient should consider risks
and benefits of treatment options, including removal or revision surgery.
• If a hypersensitivity reaction develops to a device treated with InhibiZone, the cuff
and pump should be removed and the patient treated appropriately.
• Female patients with persistent incontinence should be evaluated to rule
out vesicovaginal fistula, which may have resulted from an unrecognized
iatrogenic injury.

PRECAUTIONS

Surgery-Related
• Improper cuff sizing, improper balloon selection, or other causes may result in
tissue erosion, migration of components, or continued incontinence.
• Component migration can occur if the cuff is sized improperly, if the pump or
balloon is not positioned correctly, or if the tubing lengths are incorrect. Migration
can result in pain, complications, device malfunction, and surgical revision.
• Unsuccessful outcomes have been reported due to improper surgical technique,
such as anatomical misplacement of components, improper sizing and/or filling
of components, as well as tubing kinks. Product wear, component disconnection,
or other mechanical problems may lead to malfunctioning of the components and
leakage of fluid.
• Tubing kinks may result if the connecting tubing is cut to an improper length during
the implant procedure.
Device-Related
• Quick Connect Window Connectors should not be used in revision procedures
involving previously implanted component tubing. Suture-Tie Connectors should
be used in revision procedures. The Quick Connect system may be used in revision
surgeries when all previously implanted components are removed and replaced
with new components.
• The stainless steel tubing plugs in the Deactivation Package contain nickel, which
may cause an allergic reaction in individuals with nickel sensitivity.
• If the deactivation valve is closed when the cuff is inflated, fluid cannot transfer
from the cuff to the balloon and sustained outflow obstruction may occur.
In the event of large pressures within the bladder, automatic pressure relief that
normally occurs with the device would be prevented. Cycling the device can relieve
the outflow obstruction.
Cycling the device may be difficult if deactivation occurs when the pump bulb
is deflated. If unable to cycle the device, squeezing the sides adjacent to the
deactivation button will allow fluid to fill the pump bulb and then the pump can be
cycled normally.
Release of the deactivation valve may require greater pressure than that used to
cycle the device.
• System pressure changes may occur over time if the balloon is filled with
radiopaque solution of incorrect concentration. Follow the instructions in the Filling
Solutions section to prepare the radiopaque solution in the correct concentration.
5
Black (K) ∆E ≤5.0