Contents Of Package - Medtronic ATTAIN COMMAND 6250C Manuel Technique

M706639B_ch.fm 4/24/09 11:13 am
UC2005xxxxx EN US/OUS EE MR
4.875 x 7.125 inches (123.825 mm x 180.975 mm)
M706639B001D.book
English
1 Description
The Medtronic ATTAIN COMMAND™ Model 6250 left-heart delivery
system is designed to facilitate lead implantation in the left heart via the
coronary sinus.
The left-heart delivery system features 1 guide wire to facilitate venous
access, 1 valve to reduce blood loss during the implant procedure, 2
guide catheters for passing transvenous devices and leads, 1 guide-
catheter dilator to facilitate guide catheter passage, and 1 slitter for
removing guide catheters.
Dispose of all single-use accessories according to local environmental
requirements.

1.1 Contents of package

The left-heart delivery system contains catheters and accessories in a
tray.
The sterile tray contains the following components:
■ combination (2) of the following guide catheters:
6250-MB2, 45 cm 6250-MP, 50 cm
6250-45S, 45 cm 6250-50S, 50 cm
6250-EH, 50 cm 6250-MB2X, 50 cm
6250-MPX, 50 cm
1 guide wire, 120 cm, 0.035 in. diameter
■
■ 1 guide-catheter dilator
■ 1 valve
■ 1 slitter
product documentation
■
The sterile tray contents have been sterilized with ethylene oxide before
shipment.
2 Indications for use
The left-heart delivery system is intended for introducing transvenous
devices and leads into vessels of the left heart via the coronary sinus.
3 Contraindications
If the patient has obstructed or inadequate vasculature, for either venous
access or in the coronary sinus, the lead delivery system is
contraindicated.
4 Warnings and precautions
Use extreme care when passing the guide catheter through the vessels.
Do not push, pull, or rotate the catheter against resistance to minimize
risk of perforation and dissection. If resistance is met, discontinue
movement, determine the reason for resistance, and take appropriate
action.
Due to the relative stiffness of the catheter, damage to the walls of the
vessels may include perforations or dissections.
The flush port on the valve must be aspirated, thoroughly flushed, and
free of air prior to use. Air remaining in the valve could cause an air
embolism in the patient.
Back up pacing should be readily available during implant. Use of the
delivery system or leads may cause heart block. For further information
about this and other potential adverse events or complications, refer to
the product documentation packaged with the products chosen.
The guide-catheter dilator must be retracted within the guide catheter tip
to minimize the risk of perforation when in the right chamber of the heart.
Ensure the valve is sealed if you withdraw fluid through the flush port.
When fluid is withdrawn through the flush port, it is possible to entrain air
through the valve. The valve should also be sealed if you inject fluids
through the flush port.
Do not use the valve with fluid injection systems that will produce
pressures exceeding 15 psi.
Thrombogenicity evaluations were conducted using a heparinized
model. If your patient cannot be adequately anticoagulated, it is
unknown whether thrombus formation may occur with this product.
Inspect the sterile package with care before opening it:
■ Contact a Medtronic representative if the seal or package is
damaged.
Do not store this product above 40 °C (104 °F).
■
■ Do not use the product after its expiration date.
The left-heart delivery system is for single use only and is not intended
to be resterilized.
5 Potential complications
Potential complications related to the use of the left-heart delivery
system include, but are not limited to, the following:
M706639B001 Rev D
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6 Directions for use
The instructions for using the left-heart delivery system kit include
assembling the catheter, inserting the guide-catheter assembly and
accessing the coronary sinus, inserting transvenous devices or the lead
and removing the guide catheter.
Warning: Back up pacing should be readily available during implant.
Use of the delivery system or leads may cause heart block. For further
information about this and other potential adverse events or
complications, refer to the product documentation packaged with the
products chosen.
Note: Do not use solutions such as alcohol or mineral oil to wipe or flush
the catheter.
6.1 Assembling the catheter
This kit includes 2 guide catheters to accommodate physician preference
and patient anatomy.
Figure 1. Attaching the valve to the guide catheter
6.2 Inserting a percutaneous introducer
Refer to the technical manual packaged with a 3.0 mm (9 Fr)
percutaneous introducer for further instructions on selecting an insertion
site and gaining venous access.
Note: Use a 120 cm, 0.035 in diameter guide wire for gaining venous
access with a fixed-shape catheter.
6.3 Inserting the guide-catheter assembly and accessing the
coronary sinus
Warning: Do not push, pull, or rotate the catheter against resistance to
minimize risk of perforation and dissection. If resistance is met,
discontinue movement, determine the reason for resistance, and take
appropriate action.
6.3.1 Using a fixed-shape guide catheter
6
Medtronic Confidential
Acc_DVD_R02
11:12 AM
air embolism
allergic reaction to contrast media
arteriovenous fistula formation
bleeding at the insertion site
brachial plexus injury
cardiac tamponade
dislodgment
dissection
endocarditis
heart block
hematoma formation
1. Attach a valve to the hub of the guide catheter (Figure 1).
2. Flush the guide catheter through the valve flush port with saline or
heparinized saline prior to use.
Warning: The flush port on the valve (Figure 1) must be aspirated,
thoroughly flushed, and free of air prior to use. Air remaining in the
valve could cause an air embolism in the patient.
3. Flush the guide-catheter dilator.
4. Insert the guide-catheter dilator through the valve and into the guide
catheter. The distal end of the guide-catheter dilator should extend
past the distal end of the guide catheter.
Note: A straight guide catheter requires the use of a 2.3 mm (7 Fr)
or smaller steerable catheter. This should be used in place of a
guide-catheter dilator.
5. Set the assembled guide catheter aside within the sterile field.
1. Place the guide-catheter assembly over the guide wire and through
the lumen of the introducer sheath. The guide wire should be
extended beyond the distal end of the guide-catheter assembly
throughout the procedure.
Refer to the "Acc_DVD" category in
doc#163256 for Printing Instructions.
■ hemothorax
■ infection
irregular heart beat
■
mediastinal widening
■
perforation
■
■ pneumothorax
■ subclavian artery puncture
■ thrombophlebitis
thrombosis
■
valve damage
■
vascular occlusion
■
■ vessel damage
Valve
Stopcock
Flush port