Post-Procedure Information; Troubleshooting - Boston Scientific AMS 800 Mode D'emploi

Note:
• It is important to leave a slight indentation in the pump bulb to ensure there is
enough fluid in the pump to activate the device later.
• You will always feel the deactivation button, even when the device is
deactivated.
• The pump bulb will remain partially filled until activated. When the device is
deactivated, the cuff will not be inflated (urethra not closed) and your patient will
be incontinent. No fluid will move into the cuff or pump when it is deactivated.

POST-PROCEDURE INFORMATION

Some surgeons use a prophylactic antibiotic prior to surgery and intravenous antibiotics
immediately postoperatively. Most choose to send their implanted patients home with a
five to ten day course of antibiotics. The following paragraphs provide additional details
on postoperative care.
Immediately Postoperative
After the surgery, deactivate the cuff and introduce a catheter into the urethra prior to
closing. The length of time the catheter is left in place is at the discretion of the physician.
After 24 hours, the nursing staff may place ice packs in the region of the pump to reduce
postoperative edema. The patient should be advised about using absorbent pads or
condom catheters until the device is activated four to six weeks after the surgery. The
patient should be advised to avoid undue compression of the cuff area.
After Release from Hospital
The patient is usually discharged within one to four days after surgery.
The patient must return to the physician's office to activate the device prior to use of the
AMS 800 AUS. The device is normally activated four to six weeks postoperatively. To
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determine that the patient is ready to use the device, check the incision site to be sure
that it has healed properly.
At that time, instruct the patient that it is possible to begin using the prosthesis to urinate.
The patient may experience some mild discomfort the first few times the prosthesis is
being used.
Note: During voiding, patients with a slow or weak stream may find that voiding has not
been completed before the cuff automatically closes and restores continence. In this
case, the patient should be advised to deflate the cuff a second time to finish voiding.
Activating the device may be difficult if deactivation occurred when the pump bulb
was deflated. If unable to cycle the prosthesis, squeezing the sides of the control pump
adjacent to the deactivation button will allow fluid to fill the pump bulb and then the
pump can be cycled normally. Refer to the Activate (Reactivate) Cuff: Normal Method
section.
There should be no redness, swelling, or drainage. Any of these things may indicate that
an infection is present and the infection should be treated appropriately. Ask the patient
about tenderness and/or discomfort when cycling the device.
The physician may want to observe the patient for up to an hour in the office to determine
if sufficient continence is achieved with the device activated.
Provide patient education about the operation. Patients should carry a permanent patient
ID card to inform others of the device in case of emergency and to prevent catheterization
without device deactivation (which could damage the urethra or the device).
Activate (Reactivate) Cuff: Normal Method
To activate (reactivate) the device, complete the following instructions. See the
Troubleshooting section for optional methods.
Push the deactivation button a few times to loosen the poppet inside the valve block.
Then give the pump bulb a quick, forceful squeeze (Figure 48).
Figure 48. Activate (reactivate) the cuff:
Normal method
Black (K) ∆E ≤5.0
Figure 49. Cuff and pump refilled
Note:
• This will move the deactivation poppet back to activated position. After the device is
activated, the pump will fill first and then cuff will refill (Figure 49). It will take a few
minutes for the device to refill and for the cuff to close off the urethra or bladder
neck. When the system is activated, the pump may become less firm.
• If it is difficult to activate the device, there may not be enough fluid remaining in
the pump to push the deactivation button to its activated position. Use an optional
method described in the Troubleshooting section if this happens.
Evaluating Long-Term Function and Placement
After the postoperative healing period, the surgeon should continue to have contact
with the patient at least on an annual basis to evaluate the function of the device.
During the annual evaluation, the surgeon should ask the patient about how the device
is functioning and if he or she has noticed any changes in the function.
If the patient is having mechanical difficulty with the device, or there is infection or
erosion present, revision or removal surgery may be necessary. In the event of a revision
surgery, follow the same preparation and implantation techniques outlined herein.
Suture-Tie Connectors must be used to connect any original tubing to new tubing.
CAUTION: In a revision case, when radiopaque solution was used for the primary case,
and one or more primary components are preserved, use the same radiopaque solution
at the same density. Device performance may deteriorate if different types or densities
of filling solutions are mixed and the isotonicity may be lost or particles may form.
Deactivation Package
The Deactivation Package is useful during revision surgical procedures. The following
example describes explanting only the cuff and preserving the other components.
When the cuff needs to be explanted due to erosion, first clamp the tubing (clear KRT)
with shod hemostats at both sides of the connector. Then, cut the tubing (clear KRT) and
explant the cuff. Unless infected, the pressure regulating balloon and control pump may
be left in the body, with the tubing plugs inserted into the tubing ends while the tissue
around the urethra heals after the cuff is explanted.
By inserting a tubing plug into the end of the control pump tubing (clear KRT), the surgeon
can protect the filling solution from contamination by blood or other materials during
deactivation.
1. Flush the inside of the tubing end with a 22 gauge blunt needle attached to a
syringe, then insert a tubing plug from the Deactivation Package.
2. Suture-tie the tubing plug with 3-0 non-absorbable suture. When tying, use one
double-throw, overhand surgical knot followed by at least two single throw knots to
attach the connector to the tubing. The suture should clamp the tubing, but not so
tight that it cuts the tubing.
3. The tubing plug connected to the control pump tubing is placed in the same
superficial location as the original connectors, and the incision is closed.
4. After healing takes place, when the new cuff is inserted, clamp the tubing beneath
the tubing plug with a shod hemostat. Remove the plug. Make sure the ends of the
tubing have been cut squarely. Using a 22 gauge needle attached to a 10 ml syringe,
flush the end of the tubing with system fluid. Reconnect to the component using a
Suture-Tie Connector. No additional filling or priming is necessary as all the original
fluid is maintained within the system.

TROUBLESHOOTING

Attaching a Second Cuff to the System
Clinical literature reports that some patients with severe stress incontinence may
continue to report some degree of incontinence even after the placement of an
artificial urinary sphincter. In such cases, two cuffs may be implanted around the
bulbous urethra in males. The second cuff is connected to the device system using
a Y Connector included in the AMS 800 Accessory Kit. If the patient is experiencing
incontinence secondary to urethral atrophy at the site of the first cuff, the first cuff may
also require replacement with a smaller cuff or cuff may need to be repositioned. Usable
cuff combinations are shown in Table 10.
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