ATTAIN CLARITY™ 6225
Venogram Balloon Catheter
Technical manual
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by or on the order of a physician.
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respective owners.
Attain Clarity, Medtronic
Explanation of symbols on package l abeling
Infusion port
Balloon
Inflation port
Marker band
Syringe
Stopcock
Refer to the package labels to see which symbols apply to this product.
Date of manufacture
Manufacturer
Use by
Lot number
Catalogue number
Sterilized using ethylene oxide
Do not use if package is damaged
Do not reuse
Maximum storage temperature
Stopcock
Venogram balloon catheter
1 Device description
The Medtronic Attain Clarity Model 6225 Venogram Balloon Catheter is
designed for use within the coronary sinus to infuse contrast solutions for
occlusive venogram imaging. The balloon catheter consists of polymeric
tubing with an infusion port and an inflation port in the main body of the
catheter (Figure 1). The inflation port features a luer lock at the proximal
end. Inflation is achieved through the use of a controlled stroke fixed
volume syringe attached to a stopcock. The stopcock is manually
attached to the balloon catheter. Both the stopcock and t he syringe are
supplied with the device. A silicone balloon is located near the distal end;
a marker band is located proximally to the balloon to help with visualizing
the location of the balloon under fluoroscopy. The infusion port has a luer
lock at the proximal end.
Peel here
Consult instructions for use at
www.medtronic.com/manuals.
Contents: one device
Package contents
Manufactured in
Nonpyrogenic
Inflation Volume Maximum
Balloon diameter at nominal
Guide Catheter/Minimum inner
diameter
Maximum guide wire diameter
Usable length
Inflation Volume Nominal
Syringe
Figure 1. Model 6225 Venogram Balloon Catheter
1.1 Contents of package
Each package contains the following:
■
One venogram balloon catheter
■
One 2.5 ml syringe
■
One stopcock
■
Product documentation
2 Indications for use
The venogram balloon catheter is indicated for use within the coronary
sinus; it is intended for infusing contrast solutions into the coronary
vasculature for occlusive venogram imaging.
3 Contraindications
The venogram balloon catheter is contraindicated for patients with a
known allergy to contrast medium.
4 Warnings and precautions
For single use only – This device is provided sterile and is for single
use, for one procedure only. This device is intended to contact bo dy
tissues. Do not reuse, reprocess, or resterilize. Reprocessing,
resterilization, or reuse may comprom ise the mechanic al or structural
integrity of this device and may compromise essential material and
design characteristics leading to device failure. Reprocessing,
resterilization, or reuse of this device may compromise the st erility of the
device and create a potential risk of patient or user infections due to the
use of a contaminated or unsterile device. Modification of packaging and
labeling may also lead to product mi x-up or use beyond shelf life,
possibly leading to patient injury or death.
Maximum inflation volume – Do not exceed the recommended
maximum balloon inflation volume (2.75 ml). Exceeding this volume will
not appreciably increase the diameter of the balloon and will increase the
probability of balloo n r upture. Refer to the “ Specifications” section f or
maximum inflatio n volume.
Inflation media – Do not use liquids as a balloon inflation media this
impacts catheter performance and the ability to deflate the balloon.
Injecting contrast solution – Do not inject contrast solution into the
infusion port if blood cannot be aspirated, t o avoid pulmonary
extravasation.
Recommended trai ning – Although diagnostic cardiac catheterization
procedures have proven to be safe, certain complications can occur. It is
recommended that the user of this product becomes familiar with the
evidence based guidelines for the safe u se of the venogram balloon
catheter.
Guide catheter compatibility – Use the Attain Clarity only with
compatible guide catheters. Refer to the section “Specifications” on
page 4 for additional information on compatible guide catheters. No test
data is available to demonstrate compatibility of Attain Clarity with nonMedtronic guide catheters. Consequences of using At tain Clarity with
3
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