Merit Medical Asap Instrucciones De Uso página 2

I N S T R u C T I O N S f O R u S E
INTENdEd uSE
The Merit ASAP Aspiration Catheter is intended for the removal of fresh, soft emboli and
thrombi from vessels of the arterial system.
CAuTIONS
RX Only: Caution: Federal Law (USA) restricts this device to sale by or on the order
of a physician.
Read instructions prior to use
Store in a cool, dry place
Inspect contents prior to use
Do not expose to organic solvents such as alcohol.
Product is intended for single use only.
Do not reuse or re-sterilize; do not autoclave.
Do not use if package is opened or damaged.
The ASAP Aspiration Catheter should be used by physicians with adequate training in the use
of the device.
Kit components should not be substituted.
Contents of unopened, undamaged package are sterile and non-pyrogenic.
Crossing a freshly deployed drug eluting stent could damage the delicate drug coating.
wARNINGS
Do not use a bent, kinked or damaged catheter as this may lead to vessel injury and/or an
inability to advance or withdraw the catheter.
Do not advance the guide wire if resistance is met.
Do not place more than 60mls of fluid in the MicroStop fluid collection basin.
The ASAP Aspiration catheter must be used with a guide catheter with a minimum internal
diameter of 0.070"/1.78mm.
Do NOT flush the system while the catheter is still inside the patient vasculature.
POTENTIAl COMPlICATIONS
Potential complications include, but are not limited to:
Local or systemic infection; local hematomas; intimal disruption; arterial dissection; perfora-
tion and vessel rupture; arterial thrombosis; distal embolization of blood clots and plaque;
arterial spasm; arteriovenous fistula formation; catheter fracture with tip separation and
distal embolization; acute myocardial infarction; emergent surgery; death; abrupt closure of
total occlusion of treated graft or vessel; distal embolization of debris resulting in pulmonary
compromise and/or limb ischemia; death, myocardial infarction; coronary or bypass graft
thrombosis or occlusion, myocardial ischemia; stroke/CVA; emergent or non-emergent
fibrillation; hemorrhage; hypotension; pseudo aneurysm at access site.
Risks normally associated with percutaneous diagnostic and/or interventional procedures.
CONTRAINdICATIONS
Do not use in vessels less than 2.0mm in diameter.
The venous system
The removal of fibrous, adherent or calcified material (i.e. chronic clot, atherosclerotic plaque)
Not for use in the cerebral vasculature.
AddITIONAl EquIPMENT REquIREd buT NOT SuPPlIEd
Guiding catheter with an internal diameter
Guide wire with diameter of ≤0.014"/0.36mm
Rotating hemostasis valve
Sterile, heparinized normal saline for system flushing
PROduCT dESCRIPTION
The ASAP Aspiration Catheter Kit contains a dual lumen rapid exchange catheter, compatible
with 0.014"/0.36mm guide wires with related accessories. The catheter has a maximum outer
diameter of 0.068"/1.73mm and a working length of 140cm. The catheter is placed through a
6F guide catheter with a minimum inner diameter of 0.070"/1.78mm. The catheter has a radi-
opaque marker band located approximately 2mm proximal to the distal tip. The catheter has
three (3) non-radiopaque positioning marks located approximately 90cm, 100cm, and 110cm
proximal of the distal tip. Catheter has a distal hydrophilic coated section of 20cm.
The kit consists of the following components. These components may be packaged together
or separately.
(1) ASAP Aspiration Catheter
(2) 70 micron pore filter baskets
(1) Extension tubing set (8 ½"/21.5cm total length) with one-way stopcock
(1) RXP™ flush syringe (4ml)
Aspiration Catheter
of at least 0.070"/1.78mm
(2) 30ml VacLok® syringes
(1) MicroStop fluid collection basin
hydrophilic coating 20cm
English INSTRuCTIONS fOR uSE
The following instructions provide technical direction but do not obviate the necessity of for-
mal training in the use of extraction or aspiration catheters. The techniques and procedures
described do not represent all medically acceptable protocols, nor are they intended as a
substitute for the physician's experience and judgment in treating any specific patient.
Preparation and Directions for Use:
1. Open the ASAP Aspiration Kit box. Using aseptic technique, open the pouch and transfer
the tray onto the sterile field.
2. Remove the catheter hoop containing the ASAP catheter and other kit components from
the tray. Attach a 10ml syringe, (or one of the 30ml VacLok syringes included in
kit), filled with heparinized saline to the flush port on catheter hoop; flush hoop
completely to activate hydrophilic coating on distal portion of catheter.
3. Inspect the catheter for any bends or kinks. Remove the wire stylet from the rapid
exchange lumen.
4. Use 4ml RXP syringe filled with heparinized saline to flush rapid exchange lumen.
5. Flush extension tubing set with heparinized saline prior to use. Using one of the VacLok
syringes, draw 5-10ml of heparinized saline into the syringe. Attach the extension tubing
set with stopcock to the catheter. Turn the stopcock to the "open" position and flush with
the heparinized saline solution to remove all air from the system.
6. Turn the stopcock to the "off/closed" position after the catheter system is properly flushed.
Verify that the stopcock on the extension tubing set is in the closed position and connect
the VacLok syringe to the tubing set. Check that all fittings are secure so that air is not
introduced into the extension line during aspiration/extraction.
7. VacLok syringe setup: To create and maintain vacuum, withdraw the VacLok syringe
plunger to the desired position and rotate the plunger clockwise to position one of the
locking fins behind the stop pin. Turn the plunger counterclockwise to release. (see fig. A)
8. Check that all fittings are secure so that air is not introduced into the extension
line or syringe during aspiration. At this time verify that the extension tubing
set with stopcock is on the catheter (stopcock in the "closed" position) with
VacLok syringe attached . The ASAP catheter is completely prepped and is
ready for use.
uSE Of THE ASAP CATHETER duRING AN INTERvENTIONAl PROCEduRE
Perform aspiration using the ASAP Catheter:
9. Load the prepped ASAP Catheter over the ≤0.014"/0.36mm guide wire
10. Confirm that the tubing set/VacLok have been connected to the catheter prior to
placement through guide catheter.
11. Advance the ASAP Catheter through the guide catheter, under fluoroscopy, and continue
to advance the catheter over the guidewire to the selected vascular site. The ASAP
catheter has three non-radiopaque positioning marks indicating 90cm, 100cm & 110cm
from the catheter tip. Position the distal tip marker proximal to the desired site. Stop
advancement of the ASAP Catheter if any resistance is encountered.
wARNING: Never advance or withdraw an intravascular device against resistance until the
cause of the resistance is determined by fluoroscopy. Movement of the catheter or guide wire
against resistance may result in damage to the catheter, or vessel perforation.
12. After fluoroscopically confirming catheter position, open the stopcock to begin aspiration.
Advance the catheter slowly distally away from the guiding catheter. Blood will enter the
VacLok Aspiration Syringe until the entire vacuum is gone (or the VacLok Aspiration
Syringe is filled).
a. If the syringe does not begin to fill with blood within 5 seconds, close stopcock and
remove ASAP catheter. Flush the catheter (extraction lumen) or use a new catheter.
Repeat steps 9-11 .
warning – Do not flush the system while the catheter is still inside the patient vasculature.
b. After completing the aspiration process, turn the stopcock to the "Off" position and
remove the catheter, or attach a second syringe and repeat aspiration.
c. Blood and thrombus aspirated into the syringe may be filtered for subsequent
laboratory analysis.
To use the basket, wet the mesh to allow fluid flow. Place filter basket in MicroStop fluid
collection basin. Carefully dispense extracted blood into filter basket (blood will go through
filter basket and collect in MicroStop) and filter the extracted blood through the filter basket.
Any fresh, soft emboli and/or thrombi (larger than 70 micron) that have been aspirated
should remain in the filter basket. If necessary, use the second filter basket included in the kit
to continue filtering blood.
13. Remove the ASAP Catheter: if necessary, loosen the rotating hemostasis valve to allow
easy withdrawal of the catheter.
Figure A
FREE SLIDING USE
LOCKS TO HOLD VACUUM