Indications For Use - Merit Maestro Instrucciones De Uso

MICROCATHETER
I n s t r u c t I o n s f o r u s e
descrIptIon:
The Merit Maestro Microcatheter is available in three French size configurations. The first configuration
incorporates a change in its outside diameter along its length from a 2.8F (0.93mm) proximal region to a 2.4F (0.80mm)
flexible distal region of 20cm in length. This configuration employs a nominal proximal inner diameter of 0.025" with a
nominal tip inner diameter of 0.020".
The second configuration maintains a 2.8F (0.93mm) diameter throughout its length, but also incorporates a 20cm
flexible distal region. The I.D. of this configuration has a nominal 0.025" inner diameter in the proximal region and a distal
region inner diameter of 0.024".
The third configuration maintains a 2.9F (0.96mm) diameter throughout its length, but also incorporates a 20cm
flexible distal region. The I.D. of this configuration has a nominal 0.027" inner diameter in the proximal and distal
regions.
The Microcatheter lumen is able to accommodate steerable guide wires. A lubricious, hydrophilic coating is
applied to the distal 80cm outer surface of all catheter configurations. The Microcatheter has a
radio-opaque marker at the distal tip, located approximately 1.3mm proximal of the distal limit of the tip, to
facilitate fluoroscopic visualization. The proximal end of the Microcatheter incorporates a standard Luer adapter to
facilitate the attachment of accessories.

IndIcatIons for use:

The Microcatheter is intended for general intravascular use, including peripheral and coronary
vasculature. Once the subselective region has been accessed, the Microcatheter can be used for the controlled and
selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
The catheter should not be used in the cerebral vessels.
contraIndIcatIons:
None known
warnInGs:
1. Due to contractual agreements, this Microcatheter is not for neurovascular use at or above the common
carotid artery or at or above the vertebral artery.
2. This device is intended to be used only by physicians trained in percutaneous intravascular techniques
and procedures.
3. Contents supplied sterile using an ethylene oxide (EtO) process. Do not use if sterile barrier is damaged.
4. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization 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. Reuse, reprocessing or resterilization 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. After use,
dispose of product and packaging in accordance with hospital, administrative, and/or local government policy.
5. The infusion dynamic pressure with this Microcatheter should not exceed 800psi (
pressure in excess of this maximum may result in Microcatheter rupture, possibly resulting in patient injury.
If flow through the Microcatheter becomes restricted, do not attempt to clear the Microcatheter lumen by
infusion. The static pressure with this Microcatheter should not exceed 2068 kPa/300psi. Static pressure in
excess of this maximum may result in Microcatheter rupture, possibly resulting in patient injury. Identify and
resolve the cause of the blockage or replace the Microcatheter with a new Microcatheter before resuming
infusion.
6. Make sure that the guiding catheter does not slip out of the vessel. If the guiding catheter should leave the
vessel when the Microcatheter and/or the guide wire is moved, this may result in the damage of the
Microcatheter system.
7. Microcatheter advancement beyond the end of the guide wire may result in vessel trauma.
8. Do not use a power injector to infuse agents other than contrast media, as the Microcatheter may become
blocked. The safety setting of injection pressure must not exceed the maximum injection pressure of 800psi
( ). Exceeding injection pressure beyond the maximum injection pressure may cause Microcatheter
5515 kPA
rupture. (See Instructions For Using a Power Injector)
precautIons:
1. R only: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
X
2. Ensure embolic material compatibility with Microcatheter prior to use.
3. Always monitor infusion rates when using the Microcatheter
4. When injecting contrast for angiography, ensure that the Microcatheter is not kinked or occluded.
5. The Microcatheter has a lubricious hydrophilic coating on the outside of the catheter. It must be kept
hydrated prior to removal from its carrier and during the actual procedure in order to be lubricious. This can
be accomplished by attaching the Y-connector to a continuous saline drip.
6. Prior to a procedure, all equipment to be used for the procedure should be carefully examined to verify proper
function and integrity.
7. Inspect the Microcatheter prior to use for any bends or kinks. Any Microcatheter damage may decrease the
desired performance characteristics.
8. Exercise care in handling of the Microcatheter during a procedure to reduce the possibility of accidental
breakage, bending or kinking.
9. When the Microcatheter is in the body, it should be manipulated only under fluoroscopy. Do not attempt to
move the Microcatheter without observing the resultant tip response.
10.Exchange Microcatheters frequently during lengthy procedures that require extensive manipulation or
multiple guide wire exchanges.
11.Never advance or withdraw an intravascular device against resistance until the cause of the resistance is
determined by fluoroscopy. Movement of the Microcatheter or guide wire against resistance may result in
separation of the Microcatheter or guide wire tip, damage to the Microcatheter, or vessel perforation.
12.Because the Microcatheter may be advanced into narrow subselective vasculature, repeatedly assure that
the Microcatheter has not been advanced so far as to interfere with its removal.
13.Excessive tightening of a hemostatic valve onto the Microcatheter shaft may result in damage to the catheter.
14.Read and follow the manufacturer's IFU for diagnostic, embolic, or therapeutic agents to be used with this
Microcatheter.
15.Do not use opened or damaged packages. Use prior to the "use before" date.
Store at controlled room temperature.
potentIal coMplIcatIons:
Possible complications include, but are not limited to:
English
table 1: coMpatabIlIty InforMatIon
InstructIons for use: note:
sheath introducer.
1. Place the appropriate guiding catheter using standard technique. A rotating hemostasis valve may be
connected to the guiding catheter luer adapter to continuously flush the guiding catheter with saline.
2. Remove the spiral holder housing the Microcatheter from its sealed packaging.
3. Attach a syringe filled with heparinized saline solution or sterile water to the luer lock fitting of the
Microcatheter holder.
4. Inject enough solution to wet the Microcatheter surface entirely. This will activate the hydrophilic coating on
the Microcatheter surface. Note: The surface of the Microcatheter may become dry after removal from the
holder. Additional wetting with heparanized saline or sterile water will renew the hydrophilic effect.
5. Upon removal of the Microcatheter from the spiral holder, inspect Microcatheter to verify there is no damage
prior to insertion.
6. Attach a second hemostasis valve with side-arm adapter to the Microcatheter, purge any air and flush with
heparinized saline or sterile water.
7. Carefully insert guide wire into the Microcatheter and completely close the valve around the guide wire.
8. Introduce the Microcatheter and guide wire assembly into the guiding catheter via the hemostasis valve (if
). Infusion
5515 kPA
used). If rotating hemostatic valve is used, tighten the valve around the Microcatheter to prevent backflow,
but allowing some movement through the valve by the Microcatheter.
9. Using fluoroscopy, introduce the Microcatheter and guide wire assembly into the vascular system, making
sure the guide wire is always ahead of the Microcatheter. Advance the guide wire and Microcatheter to a
selected vascular site by alternatively advancing the guide wire and then tracking the Microcatheter over the
guide wire. Note: To facilitate Microcatheter handling, the proximal portion of the Microcatheter is uncoated
to ensure a non-slip grip.
10. Final positioning is accomplished by short advances of the guide wire and Microcatheter until the desired
position is achieved and then confirmed by fluoroscopic visualization.
11. Monitor Microcatheter placement and position during use.
12. To infuse, completely remove the guide wire from the Microcatheter. Connect a syringe with infusate to the
Microcatheter manifold luer, and infuse as required.
InstructIon for usInG a power Injector wIth the MIcrocatheter:
A power injector can be used to infuse a contrast media through the Microcatheter. Observe the warnings and cautions
given below. The flow rate depends upon such factors as the viscosity of the contrast media, which varies with the type
and temperature of the media, the model and setting of the power injector, and how the
injector is connected to the Microcatheter. The observed flow rate values indicated below are for reference only.
flow rate tables
Merit
Maestro
Catheter
Size
Shaft/Tip
2.8/2.4F
2.8/2.8F
2.9/2.9F
REFERENCE DATA
1. Injector used: MEDRAD MARK V
3. Injection pressure monitor/ limit setting: 5515 kPa (800psi)
5. Linear rise seconds: 0.3 sec.
Access site complications
Vessel perforation
Vessel Spasm
Hemorrhage
Pain and tenderness
Embolism
Allergic reaction
Nominal
Microcatheter Microcatheter
O.D. I.D.
2.8F / 2.4F 0.020" (0.52mm)
2.8F / 2.8F 0.024" (0.62mm)
2.9F / 2.9F 0.027" (0.68mm)
e M b o l I c s
Particles
2.8F / 2.4F ≤ 700 um Emboli
2.8F / 2.8F ≤ 700 um Emboli
2.9F / 2.9F ≤ 900 um Emboli
It is recommended that the Microcatheter be used with a guiding catheter and a
Usable Iodine Viscosity
Length Contrast Content (cP) at Flow Rate
(cm) Media (Mg/ml) 37°C
110 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
130 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
150 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
110 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
130 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
150 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
110 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
130 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
150 ISOVUE- 300 4.7
(Iopamidol) 370 9.4
Vascular thrombosis
Thrombis
Ischemia
Infection
Vessel Dissection
Distal embolization
Death
Maximum Recommended
Guide wire O.D. guiding catheter
0.018" (0.46mm) 0.040" (1.02mm) to
0.041" (1.04mm)
0.021" (0.53mm) 0.040" (1.02mm) to
0.041" (1.04mm)
0.021" (0.53mm) 0.042" (1.07mm) to
0.043" (1.09mm)
Spherical Coils
≤ 700 um Microspheres 0.46mm / 0.018"
≤ 700 um Microspheres 0.46mm / 0.018"
__________
≤ 900 um Microspheres
MEDRAD Flow Actual Contrast
Setting Conditions Delivery ml/sec
With Linear With Safety
Rise @ 0.3sec Pressure Setting of:
Volume 5515 kPA
(ml/sec) (ml) (800 psi)
6.0 10 5.55
3.0 10 2.54
6.0 10 5.14
3.0 10 2.21
6.0 10 4.60
3.0 10 2.00
6.0 10 5.57
3.0 10 2.63
6.0 10 5.07
3.0 10 2.37
6.0 10 4.70
3.0 10 2.18
7.0 10 6.82
4.0 10 3.44
7.0 10 6.26
4.0 10 3.40
7.0 10 5.59
4.0 10 3.20
2. Contrast Media temperature: 37°C
4. Flow scale: ml/sec
Dead
Space
(Priming)
Volume
(ml)
0.63
0.70
0.76
0.63
0.70
0.77
0.69
0.77
0.85