Rocket Medical Rocket KCH Fetal Bladder Drain Instrucciones página 4

Rocket KCH™ Fetal Bladder Drain
INSTRUCTIONS for USE
Scope: These instructions cover R57405 KCH™ Fetal Bladder Drain and derivatives
Humanitarian Device: Authorised by Federal law for use in the treatment of Fetal obstructive uropathy. The effectiveness of this device has not
been demonstrated.
Device Description: The device is a double pigtail stent with an outer tube diameter of 2.1mm and inner tube diameter of 1.5mm. The coils are
wound to 18mm diameters, 30mm between the coils. The proximal pigtail being a double coil orientated perpendicular to the stent to allow the
pigtail to lie flat against the Fetal abdomen. The distal pigtail is a one and a half coil orientated horizontally to the stent in order to hold the pigtail
inside the Fetal bladder. Both coils have 3 side ports, with distal coil tip being supported by a stainless steel tube for enhanced drainage and
ultrasound visualisation.
Indications for Use: The KCH™ Fetal Bladder Drainage Catheter is intended for use in fetal bladder decompression following diagnosis of fetal
post-vesicular obstructive uropathy in fetuses of 18-32 weeks gestation. The device is for use by or under the direct supervision of trained
personnel and accordance with national guidelines such as: Interventional procedure guidance 202: Fetal vesico–amniotic shunt for lower
urinary tract outflow obstruction. NICE Dec. 2006.
CONTRAINDICATIONS: The Rocket KCH™ Fetal Bladder Drainage Catheter should not be used in the presence of the following conditions:
Severe congenital abnormalities that jeopardise neonatal survival, abnormal karyotype, renal cortical cysts or evidence of renal failure. The device
should not be used for pleural drainage; Rocket Medical has not conducted the necessary activities to demonstrate the safety and the performance
of the device in pleural drainage.
ADVERSE EFFECTS OF THE DEVICE ON HEALTH
Reported Adverse Effects and Side Effects: Currently there are no reported adverse effects on file for the KCH™ Fetal Bladder Drainage
Catheter. However, stent/shunt migration has been reported in >50% of cases of vesico–amniotic shunt placement in the literature. In one
retrospective study, Nineteen (46.3%) fetuses underwent shunt placement at a median gestational age of 19 (range: 16.3–31.1) weeks. Shunt
dislodgement occurred in 10 (52.6%) patients. A total of 35 procedures were performed; among which 16 (45.7%) were repeat procedures. The
only prenatal factor associated with shunt dislodgement was the type of the shunt; the Rocket KCH™ catheter was associated with statistically
lower migration rates:
Ref: Kurtz et.al. Factors associated with fetal shunt dislodgement in lower urinary tract obstruction. Prenat Diag 2016;36:720-725.
wall defect and subsequent omental herniation was reported in 11% of cases in one study and in several other publications
Risks associated with Fetal-Amniotic Shunting include: chorioamnionitis, urinary ascites, pre-term labour, haemorrhage, amniotic band
syndrome, maternal sepsis, membrane rupture, amniotic fluid leak, stent obstruction or migration requiring replacement, abdominal wall defect and
subsequent omental herniation. There is no evidence that these complications are device related but a feature of the overall technique which
requires significant levels of skill and careful evaluation of all the associated risks.
WARNING: Potential Adverse Events include the following complications: ascites, maternal sepsis, amniotic fluid leak and/or complete rupture of
the membranes, direct trauma to the fetus, such as fetal intestinal perforation, uterine injury or bleeding, placental bleeding, preterm labour. There is
a possible risk that these complications may require subsequent intervention leading to spontaneous abortion and in rare cases; loss of the uterus.
CLINICAL EXPERIENCE
Note: Clinical studies have not fully demonstrated the safety and effectiveness of fetal bladder stenting. However, some studies provide reasonable
assurance of the safety of the technique. In addition there is reported clinical experience with KCH™ catheter in over 20 years of use.
PRECAUTIONS
Patient / Diagnostic Evaluation: A complete medical history should be obtained to determine conditions that might influence the selection of the
procedure or to identify conditions that mediate contraindications to use of the device.
Physicians must evaluate each case on its individual merits and only use the device where there is significant risk of renal or pulmonary damage if
no intervention is made. The physician must have concluded that the risks to the fetus outweigh the potential risks of using the device. It is
recommended that the following investigations are conducted to determine if the fetus is suitable for treatment with the KCH™ Catheter.

Ultrasound investigation to demonstrate lower obstructive uropathy, indications are normally; bilateral hydronephorosis, utreostasis,
megacystitis or oligohydramniosis.

Fetal karyotyping for chromosomal analysis to diagnose or exclude concomitant chromosomal abnormalities that may influence
management decisions or treatment choices.

Serial vesicocentesis to evaluate the fetal function through fetal urinary biochemical parameters. The parameters and their respective
cut-off values are shown below:

Serial vesicocentesis to evaluate the fetal renal function through fetal urinary biochemical parameters. The parameters and their
respective cut-off values are Na + <100mg/dl, Ca++<8mg/dl, Osmolarity <200mOsm/1, B-2-globulin <4mg/1, Protein <20mg/1
b. Patient Counselling:
It is recommended that patients should be closely counselled by the physicians to inform them of the options and the risk and benefits of using the
KCH™ Catheter.
It is recommended that the following items are discussed in details and the patients concerns fully explored:

Puncture of the uterus and uterine membranes; carries with it the risk of leakage of amniotic fluid and the potential complete rupture of
the membranes.

Implantation of the KCH™ Catheter is an invasive procedure and carries with it the risk of infection and the development of
chorioamnionitis. This could result in spontaneous abortion or the need for surgical termination. I rare cases intervention could lead to the
loss of the uterus.

As with many internal procedures during pregnancy there is a risk of premature labour.
Placement of the KCH™ Catheter may reduce the risk of renal damage, however it does not completely remove the risk that the baby may have
co-existing renal or pulmonary impairment on delivery and there may be the need to subsequently perform a renal transplant sometime in the
future. Fetal bladder drainage catheters can become dislodged or blocked and this may necessitate repeated procedures during the pregnancy to
allow replacement and/or removal.
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