Allium Bulbar Urethral Stent User manual

Allium Bulbar Urethral Stent (BUS) System
Bulbärer Harnröhren-Stent (BUS) System von Allium- DE
Allium système de Stent Urétral Bulbaire BUS-FR
Sistema Stent da Uretra Bulbare (BUS) Allium-IT
El Sistema de Stent Uretral Bulbar (BUS) de Allium-SP
- Instructions for Use –
Bedienungsanweisungen –DE
Mode d'emploi-FR
Istruzioni per l’Uso-IT
Instrucciones de Uso-SP
Manufactured by
Allium Ltd.
DE
FR
IT
SP

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Allium Bulbar Urethral Stent (BUS) System-EN
Device description:
The Allium Bulbar Urethral Stent (BUS) is a temporary implant intended for
trans-urethral insertion into the male bulbar urethra diagnosed with a stricture in
order to open the occluded passage and allow spontaneous urination. The BUS is
made of a super-elastic coil covered with a co-polymer. Once inserted into the
bulbar urethra by a delivery system, the stent is released to allow its self-
expansion. The stent is intended to remain in place up to 3 years.
Table 1 –BUS Dimensions
Nominal BUS stent
diameter (Fr)
Nominal BUS stent
lengths (mm)
Profile of delivery
system (Fr)
Working Length of
delivery system (cm)
(45)
50/60/70/80
22
20
The BUS set consists of:
1. Bulbar Urethra Stent (Figure1)
2. An Endoscopic Delivery tool (Figure 2).
3. Meatal Shield (Figure 3).
Figure 1 –Bulbar Urethra Stent (BUS)
Figure 2 - Endoscopic Delivery Tool
Irrigation Fluid
Inlet Port
Safety
Lock
Button
Trigger
22 Fr Insertion Tube
Optical
Element
Channel
Crimped Stent
Teflon
Sheath Pull
Button
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Figure 3 - Components of the Meatal shield
a - Assembled Meatal Shield
b - Dilator Sheath
c - Dilator shaft \ mandrel
The Meatal Shield minimizes
trauma to the distal urethra and
meatus during insertion of the
delivery system. The Meatal
shield (a) is composed of a
Dilator Sheath (b) and a Dilator
shaft (c).
Indications for Use:
Management of Bladder Outlet Obstructions (BOO) caused by bulbar urethral
strictures.
Contraindications:
The BUS is contra-indicated in the following cases:
1. Are younger than 18.
2. Have an acute infection of the prostate or urethra.
3. Febrile patients
4. Active urinary tract infection
5. Immuno-compromised patients, who have a prosthetic heart valve or
other implanted device
6. Patients who cannot tolerate any form of antibiotic treatment
7. Irreversible atonic/acontractile bladder
8. Anticoagulation therapy and/or bleeding disorders
9. Urethro-cutaneous/urethro rectal fistula
10. Present urinary calculi or Cystolithiasis
11. “Constriction rings” and/or vacuum erection devices
12. Use injectable medications to obtain erection
13. Patients with penile implants and/or implanted artificial urinary sphincters
14. A history of any illness, medications or surgery that may affect the efficacy
of the stent
Informing Patients, Potential Adverse Events and Complications:
The following adverse events might occur due to the implanted stent or the
implantation and extraction procedures:
1. Following the procedure some patient may endure post-voiding urinary
dribbling and post-ejaculatory seminal dribbling.
2. Some patients can develop reactive urinary frequency or urgency
3. Reactive tissue proliferation at one or both ends of the stent. In most
cases, this tissue disappears spontaneously after stent removal.
4. Hematuria
5. Pain/discomfort
6. Bleeding
7. Urinary tract infection
8. Stent migration. If this occurs, the stent should be removed and replaced
with a new one
9. Stent encrustation. If this occurs, a lithotripsy should be performed or the
stent should be removed
10. Stent misplacement
11. Mechanical damage to the urinary tract
b
c
a
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Precautions:
1. Do not use after the “use by” date.
2. The packaging should be inspected for damage.
3. The delivery system should be inspected for damage prior to use.
4. Prior to delivery, the physician should ensure that the stent is covered by
the over-tube.
5. The BUS system should be used only by physicians trained in
interventional or endoscopic techniques.
6. Prior to its use, the technical information supplied with the device should
be carefully reviewed.
Warnings:
1. The BUS is intended for Single Use Only-DO NOT RE-STERILIZE.
Reuse, reprocessing, re-sterilization or repackaging may
compromise the structural integrity and/or essential material and design
characteristics and may lead to device failure, which may result in injury to
the patient. It may also create a risk of contamination of the device which
may lead to injury, illness or death of the patient or end user.
2. The product should be carefully inspected prior to use to verify that the
sterile package has not been damaged. The device should not be used if
the package is open or damaged, or if the device has been contaminated
prior to insertion.
3. Remounting the stent onto the delivery system should not be attempted.
4. Positioning of the main body of the stent across the external sphincter may
render the patient incontinent.
5. The stent is not intended as a permanent option to treat urethral
obstructions.
6. Bladder catheterization with an implanted stent is not recommended.
Introduction and passage of a catheter through the stented urethra into the
bladder may dislodge the stent and/or damage the polymeric cover.
7. The use of transurethral instrumentation while the stent is in place is not
recommended because longitudinal compression of the stent by
instrumentation could dislodge the stent.
8. The stent should be inserted and positioned only according to the
Instructions for Use (IFU) that are detailed at this document.
9. Under-vision insertion should not be attempted in patients in whom
bleeding may impede the visualization process.
10. After use, the BUS may be a potential biohazard. Handle and dispose of
it, in accordance with any local and federal laws regarding medical waste.
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