Merit Medical EmboCath Plus Infusion Microcatheter IFU - Manual (Page 4)

DESCRIPTION
The EmboCath ® Plus Infusion Microcatheter is a tapered 3.0-
2.9F single lumen catheter designed to facilitate the
access of distal vasculature over a guidewire. The catheter
has a semi-rigid proximal shaft and becomes progressively
more flexible toward the distal end. The shaft is reinforced,
which provides improved torque transmission. The inner
lumen is lined with a lubricious material to facilitate the
movement of guidewires or other devices. The outer
diameter of the catheter is coated with a hydrophilic surface
to enhance the ability to navigate tortuous anatomy. The
distal tip of the catheter has a single radiopaque marker to
facilitate fluoroscopic visualization. The hub at the proximal
end incorporates a standard luer adapter to facilitate the
attachment of accessories. The catheter lumen is 0.028
inches and guidewires measuring up to 0.025 inches
(0.635 mm) in diameter are recommended.
INDICATIONS FOR USE
The EmboCath Plus Infusion Microcatheter is intended
for: infusion of various diagnostic, embolic and therapeutic
agents into the body’s vascular systems (peripheral);
guidewire exchange/support; and superselective
angiography of the peripheral vasculature. Diagnostic,
embolic, or therapeutic agents are to be used according
to specifications outlined by the manufacturer.
Note: Not intended for pediatric or neonatal use.
WARNING
• Contents supplied sterile.
• Do not use if pouch is opened or damaged. Verify that
the package integrity has been maintained to ensure
the sterility of the device.
• Do not use in case of any surface irregularities,
bends, or kinks. Any damage of the micro-catheter
may change its characteristics likely to affect its
performance
• Use the device prior to the “Use Before” date noted on
the package.
• For single patient use only.
Do not reuse, reprocess, or resterilize. Reusing ,
reprocessing or resterilizing may compromise the
structural integrity of the device and or lead to device
failure, which in turn may result in patient injury,
illness, or death. Reusing, reprocessing or resterilizing
may also create a risk of contamination of the device
and or cause patient infection or cross infection
including, but not limited to, the transmission of
infectious disease(s) from one patient to another.
Contamination of the device may lead to injury,
illness or death of the patient.
• Discard the product after use.
• This device should be used only by physicians
thoroughly trained in percutaneous, intravascular
techniques and procedures in relevant areas of the
anatomy.
• Do not attempt to move the catheter without observing
the catheter tip. Always maintain visualization of the
catheter under fluoroscopy.
• Do not advance or withdraw against resistance. If
resistance is met, discontinue movement, determine
the reason for resistance, and take appropriate action
before continuing. Movement of the catheter or
guidewire against resistance may result in separation
of the catheter or guidewire tip, damage to the
catheter, or vessel perforation.
• Infusion dynamic pressure with this catheter
should not exceed 800 psi (54.4 atm/bar). The
static pressure with this catheter should not
exceed 300 psi (20 atm/bar). Pressure in excess
of these maximum pressures may result in catheter
rupture or device failure, possibly resulting in patient
or user injury. If the flow of material through the
catheter becomes restricted, do not attempt to clear
the catheter lumen by infusion. Identify and resolve
the cause of the blockage or replace the catheter with
a new catheter before resuming infusion.
• Excessive tightening of a hemostatic valve onto the
catheter shaft may result in damage to the catheter.
• The hydrophilic coating has an extremely lubricious
surface only when properly hydrated.
PRECAUTIONS
• Do not expose Microcatheters to extreme
temperatures or solvents.
• Prior to use, carefully examine the Microcatheter and
packaging to verify proper function and integrity.
COMPLICATIONS
Procedures requiring percutaneous catheter introduction
should not be attempted by physicians unfamiliar with the
possible complications listed below. Possible complications
may include, but are not limited to, the following:
• Puncture site hematoma
• Infection
• Ischemia
•
Perforation of vessel or arterial wall
• Vasospasm
• Emboli
Flow Rate Table
EmboCath Plus Infusion Microcatheter Flow Rate
(cc/second)
Dead 100% 100%
Length Space Saline Ionic Non-Ionic
(cm) Volume Contrast Contrast
(cc)
300 100 0.5 3.8 1.1 1.6
psi 135 0.6 3.3 0.9 1.3
800 100 0.5 9.3 2.9 3.7
psi 135 0.6 7.0 2.3 3.0
Flow rate values are approximate
PREPARATION FOR USE
• Open carefully the pouch
• Flush the hoop with sterile heparinized saline to
activate the hydrophilic coating of the catheter.
The luer fitting attached to the hoop will facilitate the
flushing of the hoop.
• Flush the inner lumen of the catheter with
heparinized saline by attaching a saline-filled syringe
to the catheter hub.
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