Complications reported with this or other
surgical procedures for the treatment of
incontinence include:
• urinary retention due to the patient´s
inability to empty the cuff correctly
• Fluid loss due to disruption of a connection
or a pinhole leak
• Cuff and/or pump erosion (characterized
by pain, hematuria, dysuria and recurrent
incontinence)
• Abnormal detrusor function
• urethral atrophy
• Bladder-neck or urethral closure
• infection
• mechanical failure
• explantation
• pain/discomfort
• device malfunction
• delayed wound healing
• migration
• recurrent incontinence
• Bladder spasm
• difficult activation
• tissue erosion
• swelling
• Fistula formation
• Hematoma
• Hydrocele
• tissue erosion/infection
• patient dissatisfaction
• positional incontinence
• Wound infection
• urinary retention
• difficult deactivation
Clinical literature reports that a small
percentage of patients may continue to
experience incontinence after an Artificial
urinary sphincter placement.
cOmpOnents
PAcKAgiNg
the Replacement kits are supplied sterile
and packaged in double plastic pouches to
facilitate visualization of the device. each kit
is delivered in a labeled cardboard box for
additional protection.
INDIvIDUAL COMPONENTS
thE cuFF rEPlAcEMENt Kit
CONTAINS:
• 1 replacement Cuff 3.7cm (rC-37), 4.0cm
(rC-40), 4.5cm (rC-45), or 5.0 cm (rC-50)
• 2 connectors (stC-12)
• 1 blunt injection needle (Bn-15G)
• 2 non-coring injection needles (nCn-25G)
• 1 syringe 6 ml (sYr-06)
• 1 syringe 10 ml (sYr-10)
thE BAllooN rEPlAcEMENt Kit
CONTAINS:
• 1 replacement Balloon (rB-01)
• 2 connectors (stC-12)
• 2 blunt injection needles (Bn-15G)
• 2 non-coring injection needles (nCn-25G)
• 1 syringe 6 ml (sYr-06)
• 1 syringe 10 ml (sYr-10)
thE PuMP rEPlAcEMENt Kit
CONTAINS:
• 1 replacement pump (rp-03)
• 3 connectors (stC-12)
• 2 blunt injection needles (Bn-15G)
• 2 non-coring injection needles (nCn-25G)
• 1 syringe 6 ml (sYr-06)
• 1 syringe 10 ml (sYr-10)
• 1 protection tube (pt-01)
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