Rocket Medical KCH Instrucciones De Uso página 3

The pressure build-up could damage your baby's lungs and/or kidneys. This could lead to physical deformity or to your baby's
death.
If you are thinking about having this procedure performed, you should discuss it with your doctor as soon as possible. Your doctor
will be able to explain this procedure to you in more detail.
Before you make this decision, you must understand that using the Rocket® KCH™™ Catheter cannot correct the original defect. It
cannot correct the blockage in your baby's urinary tract, this will need to be treated after your baby born.
The Rocket® KCH™ Catheter will only allow urine to drain from the baby's bladder so that your baby's lungs and kidneys can
continue to grow without pressure during pregnancy.
What are the risks associated with using the Rocket® KCH™™ Catheter?
As with all surgical procedures there are some risks. These are those involved with the placement of the Rocket® KCH™™
Catheter:

Chorioamnionitis is an inflammation of the fetal membrane and can result after any procedure, including placing a fetal bladder
stent, in which a doctor places an instrument into your uterus during pregnancy. This condition may cause you to lose the fluid
around your baby or may cause infection in your baby and possibly cause your baby to be stillborn.

Urinary ascites is the leakage of urine into your baby's abdomen. This can occur as result of fetal stent placement although it
usually resolves itself once the bladder has began to drain through the catheter.

Placing the fetal bladder stent could cause you to go into pre-term labour. This can happen after any surgery which goes into
the uterus during pregnancy.

There might be some minor bleeding from your uterus or the placenta and minor injury to your uterus caused by the passing of
the insertion needle, Any light bleeding will usually stop after a short time.

Amniotic Band Syndrome is a rare abnormality where the babies extremities, such a fingers, toes or limbs, become trapped in
part of the amniotic sac. Its cause is still unknown but some doctors believe that puncturing the amniotic sac as occurs when
placing the KCH™™ Catheter may lead to this condition.

Maternal sepsis is an infection in the mother which can happen as a result of placing any instrument into your uterus whilst you
are pregnant. Your doctor will normally give you antibiotics before and after the procedure to help reduce this risk.

Amniotic fluid may leak from the space between your baby and the wall of your uterus. This can happen any time after your
doctor places an instrument into the uterus while you are pregnant. The needle could perforate your baby's intestine and may
cause other damage if the doctor doesn't place it accurately. The whole procedure is carried out under ultrasound to minimize
this risk.

Once the stent is implanted, there is the risk that it may become obstructed or dislodged, resulting in the need for repeated
stent placements.

Placing a fetal bladder drain could cause you to deliver your baby much earlier than planned. This could also happen if there is
an inflammation of the fetal membrane.

Clinical studies have not fully established the benefit of placing a fetal bladder stent compared to more conservative
treatments. Your doctor will advise you of the benefits and risks in your particular situation.
If you have any other questions or concerns, please ask your doctor.
WARNING: Following insertion of the KCH™ Catheter REPORT IMMEDIATELY any pain, bleeding or fluid loss to your doctor.
These abnormal conditions should be closely monitored
CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician with appropriate training

0088 ZDOCK045 050917
and experience.
This device is not manufactured
with natural rubber latex
Manufactured in the UK by:
ROCKET MEDICAL PLC Sedling Road, Washington, England, NE38 9BZ
www.rocketmedical.com
Rev 12 Copyright© 2003-2017 ROCKET MEDICAL PLC
All Rights Reserved. (GB)