Export™
Aspiration Catheter
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician.
Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications.
Explanation of symbols on package labeling
Manufacturing Site
For US Audiences Only
Minimum Guide Catheter Inner Diameter
Maximum Guidewire Diameter
1
Export™
Aspiration Catheter
1. Description
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED
THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS. The Export™ aspiration
catheter is a single operator design, dual lumen catheter, compatible with 0.36 mm (0.014 in) guidewires, and minimum 6F guiding
catheter (1.78 mm [0.070 in] minimum ID) or 7F guiding catheter (2.03 mm [0.080 in] minimum ID) and the GuardWire™ temporary
occlusion and aspiration system. It has a distal radiopaque tip marker, proximal luer-lock port, and preloaded stylet (as applicable).
The proximal luer-lock port is for connection of the aspiration line (supplied) and aspiration syringe (supplied). Also, an
appropriately sized syringe filled with an infusate may be attached to the aspiration line for the infusion of fluids.
2. Indications and Intended Use
The Export™ Aspiration Catheter is indicated for:
■
Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
■
To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
3. Contraindications
None known
4. Warnings
■
If the Export™ aspiration catheter is to be used with an 0.36 mm (0.014 in) guidewire, consult the guidewire instructions for
use (IFU) prior to use.
■
If the Export™ aspiration catheter is to be used with a minimum 6F guiding catheter (1.78 mm [0.070 in] minimum ID) or 7F
guiding catheter (2.03 mm [0.080 in] minimum ID), consult the guide catheter IFU prior to use.
■
If the Export™ aspiration catheter is to be used with the GuardWire™ temporary occlusion and aspiration system, consult the
GuardWire™ temporary occlusion and aspiration system IFU prior to use.
■
For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient
injury, illness or death. Cleaning, disinfection and resterilization may compromise the essential material and design
characteristics of the device leading to device failure.
■
Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product
from a damaged package.
■
The Export™ aspiration catheter should be handled carefully. Prior to use inspect the Export™ aspiration catheter carefully
for bends, kinks, or other damage. Do not use a damaged Export™ aspiration catheter.
■
Do not attempt to advance or retract the Export™ aspiration catheter against resistance until the cause of resistance has been
determined by fluoroscopy or other means. Maintain visualization of the length of the wire while using the Export™ aspiration
catheter specifically in the region distal to the guide catheter and proximal to the Export™ aspiration catheter marker band.
Should a loop or excessive slack in the wire be visualized, do not attempt to retract the Export™ aspiration catheter into the
guide catheter until the loop or excessive slack is eliminated. Retracting the Export™ aspiration catheter without straightening
the wire may potentially tear the wire lumen which could cause dislodgement of the marker band into the vasculature.
■
Due to the presence of DEHP in the extension tubing of this device, it is not recommended for use in minors and pregnant or
nursing women.
■
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice
and applicable local, state, and federal laws and regulations.
5. Precautions
■
The Export™ aspiration catheter and accessories should be used in conjunction with fluoroscopic guidance and proper
anticoagulation agents.
■
Store catheters in a cool, dry place.
■
When using the Export™ aspiration catheter for fluid delivery, do not exceed the maximum flow rate specified for the device
(see Table 1).
■
This device is supplied sterile, and is designed and intended for single use only. DO NOT resterilize and/or reuse the device.
■
As in any elective coronary intervention, it is recommended that the patient have a mean systolic blood pressure greater than
or equal to 90 mm Hg in concomitant of IV pressors or intra-aortic balloon pump augmentation.
2 Instructions for Use English
6. Adverse Effects
As with most percutaneous interventions, potential adverse events include: death, myocardial infarction, coronary or bypass graft
thrombosis or occlusion, myocardial ischemia, stroke/CVA, emergent or nonemergent bypass graft surgery, emboli (air, tissue or
thrombotic), dissection, arterial perforation, arterial rupture, ventricular fibrillation, hemorrhage, hypotension, pseudoaneurysm at
access site, arteriovenous fistula, infection at access site, other bleeding complications at access site.
7. Materials Required for Use with the Export™ Infusion and Aspiration System
■
Minimum 6F or 7F arterial or venous introducer sheath and minimum 6F guiding catheter (1.78 mm [0.070 in] minimum ID)
or 7F guiding catheter (2.03 mm [0.080 in] minimum ID) in the appropriate configuration to cannulate the vessel (preferably
with side holes if ostial narrowing is present or the guide catheter is occlusive).
■
0.89 mm (0.035 in) wire may be used to support the aspiration lumen during introduction of the aspiration catheter into a
tortuous target vessel. If the Export™ catheter includes a preloaded stylet, remove the stylet prior to insertion of the 0.89 mm
(0.035 in) wire in the aspiration lumen.
■
Rotating Hemostatic Valve (RHV)
■
Heparinized normal saline.
8. Directions for Use
8.1. Preparation of the Export™ Aspiration Catheter
The Export™ aspiration catheter is supplied with an Aspiration Line, two locking Aspiration Syringes, preloaded stylet (as
applicable), and filter cup(s).
1. Remove the carrier tube containing the Export™ aspiration catheter and accessories from the package.
2. If the carrier tube has a flushing luer, attach the Aspiration Syringe filled with approximately 10 ml of heparinized saline to the
flushing luer of the carrier tube and completely flush to activate the hydrophilic coating.
3. Remove the Export™ aspiration catheter from the carrier tube. Fill the aspiration syringe with approximately 5 to 10 ml of
heparinized saline and attach the aspiration line and syringe to the Export™ aspiration catheter.
4. Open the stopcock on the aspiration line and flush the entire length of the Export™ aspiration catheter using all of the
heparinized saline contained in the aspiration syringe. Close the stopcock.
5. Verify that the stopcock on the aspiration line is in the closed position. Retract the plunger of the aspiration syringe and pull
until it locks at the fully extended position. The Export™ aspiration catheter is now completely prepped.
6. Thoroughly flush the wire lumen with heparinized saline with 10-ml syringe and flush needle (not included).
7. When using the Export™ aspiration catheter for fluid delivery, perform steps 1 through 4, and then connect an infusion syringe
of preferred volume or intravenous line to the aspiration line stopcock. Do not use the locking aspiration syringe for fluid
infusion.
8.2. Use of the Export™ Aspiration Catheter During an Interventional Procedure
1. Perform aspiration using the Export™ aspiration catheter:
a. Load and advance the prepped Export™ aspiration catheter over the guidewire to the tip of the guiding catheter.
b. Under fluoroscopy advance the Export™ aspiration catheter and position the distal tip marker proximal to the desired site.
Stop advancement of the Export™ aspiration catheter if any resistance is encountered. Do NOT attempt to align the
radiopaque marker of the Export™ aspiration catheter with the GuardWire™ radiopaque marker.
c. Begin aspiration by opening the stopcock on the aspiration line. Blood will enter the aspiration syringe until the entire
vacuum is gone (or the aspiration syringe is filled).
Note: When stiffening stylet is used, disconnect the extension line from the stylet hub, remove the stylet from the catheter,
and connect the extension line to the catheter hub prior to beginning aspiration.
Note:
■
Should blood not begin filling the syringe within 5 seconds, check the guiding catheter tip placement. Unseat the
guiding catheter if necessary to resume flow.
■
If no blood is aspirated as a result of unseating the guiding catheter, turn the stopcock off and remove the Export™
aspiration catheter. Outside of the patient, either flush the aspiration lumen or use a new Export™ aspiration catheter.
DO NOT flush the system while the catheter is still inside the patient vasculature.
■
During performance testing, the Export™ aspiration catheter demonstrated the ability to evacuate fluid and debris at
a minimum rate of 0.5 ml/second.
Caution: Remove the stiffening stylet prior to aspiration.
d. After completing the aspiration process, turn the aspiration line stopcock to close off the aspiration syringe.
Instructions for Use English 3
2. Remove the Export™ aspiration catheter.
■
Slowly retract and remove the Export™ aspiration catheter. If necessary, loosen the Tuohy Borst adapter of the RHV to
allow easy withdrawal of the distal shaft.
Note: Remove the aspiration syringe and reflush the aspiration lumen and wire lumen of the Export™ aspiration catheter
with heparinized saline. If a stylet is included with the device, reinsert stiffening stylet before each reuse. Empty the
aspiration syringe, reattach to extension line, close the stopcock, and retract the plunger to the fully extended lock position.
3. Remove the catheters and follow standard hospital practice for management of the insertion site.
8.3. Optional Steps: Use of the Export™ Aspiration Catheter for Fluid Delivery
1. After removing diagnostic or interventional devices, load and advance the prepped Export™ aspiration catheter over the
GuardWire™ to the tip of the guiding catheter.
Note: The aspiration syringe is replaced by an appropriate sized syringe filled with the fluid to be delivered or intravenous
line.
2. Advance the Export™ aspiration catheter, and position the distal tip marker at the vessel site and begin fluid delivery.
Caution: When delivering fluid through the Export™ aspiration catheter, do not exceed infusion pressures of 6.8 atm (100 psi)
or the maximum recommended flow rate per the following chart:
Table 1. Export™ Aspiration Catheter Flow Rate
Maximum Recommended Export™ Aspiration Catheter Flow Rate
Saline 4.0 ml/sec
60% Ionic Contrast Media 1.8 ml/sec
76% Ionic Contrast Media 0.5 ml/sec
9. How Supplied
The Export™ aspiration catheter is supplied with an aspiration line, two locking aspiration syringes, preloaded stylet (as
applicable), and filter cup(s); it is supplied sterile and nonpyrogenic in a die-cut card in its own pouch. The Export™ aspiration
catheter including all of its components is intended for single use only.
10. DISCLAIMER OF WARRANTY
ALTHOUGH THE EXPORT™ ASPIRATION CATHETER, HEREAFTER REFERRED TO AS “PRODUCT”, HAS BEEN
MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC, INC., AND AFFILIATES
(COLLECTIVELY, “MEDTRONIC”) HAVE NO CONTROL OVER CONDITIONS UNDER WHICH THIS PRODUCT IS USED.
MEDTRONIC THEREFORE DISCLAIMS ALL WARRANTIES, BOTH EXPRESSED AND IMPLIED, WITH RESPECT TO THE
PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OR MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY
DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, FAILURE OR MALFUNCTION
OF THE PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY, CONTRACT, TORT OR
OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR WARRANTY
WITH RESPECT TO THE PRODUCT.
The exclusions and limitations set out above are not intended to and should not be construed so as to contravene mandatory
provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict with
applicable law by a court of competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall not
be affected.
4 Instructions for Use English
Manufacturer:
*M733402B001*
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel: 763-514-4000
800-328-2518
Manufacturing Site:
Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923
USA
Tel: 877-526-7890
763-526-7890
© 2013 Medtronic, Inc.
M733402B001 Rev. 1A
Loading...