Medtronic 6215 Technical Manual

Attain™ 6215

Venogram balloon catheter

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other
countries. All other trademarks are the property of their respective owners.

Attain, Medtronic

Device description

The Medtronic Attain Model 6215 Venogram balloon catheter (Figure 1) consists of
extruded radiopaque polymeric tubing with two lumens in the main body of the
catheter. The inflation lumen features a one-way stopcock at the proximal end. Its
distal end opens into a latex balloon, which is located near the catheter tip. The
distal lumen has an infusion lumen at its proximal end. The infusion port is at the very
end of the catheter distal to the latex balloon.

Figure 1. Model 6215 Venogram balloon catheter

1 Infusion lumen
2 Inflation lumen

3 Balloon
4 Infusion port

Package contents

Dispose of all single-use accessories according to local environmental
requirements.

The venogram balloon catheter and accessories are shipped sterile. Each package
contains the following items:

• Venogram balloon catheter

• 1.25 cm3 syringe

• Product documentation

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 venogram
imaging.

The Model 6215 is intended for single use only.

Contraindications

The venogram balloon catheter is contraindicated for patients with a known allergy
to latex or contrast medium.

Warnings and precautions

Note: Medical procedure warnings and precautions that pertain to the Medtronic

implanted system are provided in the manual that is packaged with the device or on
the Medtronic Manual Library website (www.Medtronic.com/manuals).

Balloon inflation – Do not exceed the recommended maximum balloon inflation
capacity. Exceeding this volume will not appreciably increase the diameter of the
balloon and will increase the probability of balloon rupture. Refer to Table 1 for
maximum inflation capacity.

Use only filtered carbon dioxide to inflate the balloon, if there is a possibility that
balloon rupture would result in air embolism in the left side of the heart or systemic
circulation.

Do not use liquids as a balloon inflation media.
Do not inject contrast solution into the infusion lumen if blood cannot be aspirated,

to avoid pulmonary extravasation.

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Diagnostic cardiac catheterization procedures – Although diagnostic cardiac
catheterization procedures have proven to be safe, certain complications can occur,
and it is recommended that users of this product become familiar with the guidelines
established by Drs. Swan and Ganz for the safe use of the venogram balloon
catheter.

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For single use only – This device is intended only to be used once for a single
patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse.
Reuse, reprocessing, or resterilization may compromise the structural integrity of
the device or create a risk of contamination of the device that could result in patient
injury, illness, or death.

Sterilization – The Model 6215 has been sterilized in ethylene oxide prior to
shipment. Do not clean or resterilize the venogram balloon catheter. Destroy the
venogram balloon catheter after use.

Inspecting the sterile package – Inspect the sterile package with care before
opening it.

• Contact a Medtronic representative if the seal or package is damaged.

• Do not use the product after its expiration date.

Storage – Store this product between 15°C (59°F) and 30°C (86°F).
Avoid prolonged exposure to direct light in order to protect the patency of the latex

balloon.

Handling the catheter – Do not use forceps on the catheter.
Perforations, arteriovenous fistula formation, and other vascular trauma have been

reported with the use of vascular catheters. Complications may develop during any
catheterization procedure.

Potential complications

The following are known potential complications related to the use of the venogram
balloon catheter:

• air embolism

• allergic reaction to contrast media

• allergic reaction to latex

• arteriovenous fistula formation

• bleeding at the insertion site

• brachial plexus injury

• cardiac tamponade

• dissection

• endocarditis

• hematoma formation

• hemothorax

• infection

• irregular heart beat

• perforation

• pneumothorax

• subclavian artery puncture

• thrombophlebitis

• thrombosis

• valve damage

• vascular occlusion

• vessel damage

Other known potential complications related to the venogram balloon catheter
include the following:

• balloon rupture

• catheter knotting

1

Swan HNC, Ganz W, Forrester J et al: Catheterization of the heart in man with the use of a flow
directed balloon tipped catheter. N Engl J Med 283:447-451, 1970.

4

Directions for use

The procedures for using the venogram balloon catheter include testing the balloon
before use, placing the venogram balloon catheter, and obtaining a venogram.

Some techniques vary according to physician preference and the patient’s anatomy
or physical condition. The following instructions suggest one or two possible
techniques; additional methods may exist.

Note: Creating a venogram using the venogram balloon catheter requires the use
of a contrast solution. A syringe containing contrast solution should be prepared
prior to using the venogram balloon catheter. Do not use the syringe supplied with
the balloon catheter for this purpose. Refer to the documentation packaged with the
contrast medium used for the solution to determine the amount of solution required
for venogram imaging.

Note: To reduce clotting, consider a slow infusion of heparinized saline solution or
heparinized 5% dextrose solution.

Testing the balloon before use

Warning: Use only filtered carbon dioxide to inflate the balloon if there is a

possibility that balloon rupture would result in an air embolism in the left side of the
heart or systemic circulation. If carbon dioxide will be used as the inflation medium
during the procedure, then carbon dioxide must be used as an inflation medium
during balloon testing.

1. Using aseptic technique, remove the balloon catheter and accessories from
the sterile package.

2. Fill the syringe with 1.25 cm3 of inflation medium: air or filtered carbon dioxide.

3. Open the stopcock on the inflation lumen by moving the lever so that it is
parallel with the inflation lumen.

Caution: Do not inflate the balloon using a syringe other than the one provided
with the venogram balloon catheter.

4. Inject the inflation medium into the inflation lumen. Then, close the stopcock.

5. Inspect the balloon.

6. Deflate the balloon using one of the following techniques:

• If air is the inflation medium, open the stopcock to deflate the balloon.

• If carbon dioxide is the inflation medium, refill the syringe with carbon
dioxide. Open the stopcock to allow the balloon to deflate, and then inflate
the balloon a second time. Open the stopcock to allow the balloon to
deflate, and close the stopcock as soon as the balloon has deflated.

Placing the venogram balloon catheter

The venogram balloon catheter should be introduced into the body and placed
within the coronary sinus by inserting it through an appropriate guide catheter, such
as the guide catheters included in the Medtronic Attain LDS Model 6216 Left-heart
delivery system or in the Medtronic Attain Model 6218 Left-heart delivery system.

Refer to the documentation packaged with the guide catheter for instructions on the
following procedures:

• Inserting the guide catheter

• Placing the guide-catheter tip within the coronary sinus

• Inserting the venogram balloon catheter into the guide catheter

• Passing the venogram balloon catheter through the guide catheter

• Removing the venogram balloon catheter

Obtaining a venogram

1. After testing the venogram balloon catheter and passing the venogram balloon
catheter through a guide catheter positioned in the coronary sinus, use
fluoroscopy to check the placement of the balloon. The balloon should be in a
proximal coronary sinus position, and the balloon should be completely past
the distal end of the guide catheter. Use fluoroscopy to facilitate placement.

2. Prior to inflating the balloon catheter, inject a small amount of contrast solution
through the infusion lumen of the venogram balloon to verify balloon catheter
position and coronary sinus size.

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3. Fill the syringe, supplied with the venogram balloon catheter, with 1.25 cm3 of
inflation medium: air or filtered carbon dioxide.

Warning: Use only filtered carbon dioxide to inflate the balloon if there is a
possibility that balloon rupture would result in an air embolism in the left side of
the heart or systemic circulation.

Warning: Do not exceed the recommended maximum balloon inflation
capacity: 1.25 cm3. Exceeding this volume will not appreciably increase the
diameter of the balloon and will increase the probability of balloon rupture.

Caution: Do not inflate the balloon using a syringe other than the one provided
with the venogram balloon catheter.

4. Attach the inflation-medium-filled syringe to the inflation lumen; open the
stopcock; slowly inject the inflation medium into the inflation lumen, to inflate
the balloon. Stop inflating the balloon when resistance is felt, indicating that the
balloon has occluded the coronary sinus. Close the stopcock.

5. Aspirate blood through the infusion lumen to remove air from the infusion
lumen.

Warning: Do not inject the contrast solution into the infusion lumen if blood
cannot be aspirated, to avoid pulmonary extravasation.

6. With the inflated balloon occluding the coronary sinus, attach the syringe
containing the contrast solution to the infusion lumen, and slowly inject the
contrast solution through the infusion lumen and into the coronary vasculature.

Note: If carbon dioxide is the inflation medium, the balloon may partially deflate
because carbon dioxide diffuses through latex. If this happens, refill the syringe
supplied with the balloon catheter with carbon dioxide; open the stopcock to
deflate the balloon completely; inject the carbon dioxide into the inflation
lumen; and close the stopcock.

7. Create a venogram by recording a fluoroscope image of the contrast solution
in the coronary vasculature.

8. After obtaining the venogram, open the stopcock to allow the balloon to
deflate. Then, remove the venogram balloon catheter from the guide catheter
according to the instructions in the guide-catheter documentation.

Specifications

Table 1. Specifications Parameter Model 6215

Catheter body outer diameter 2.0 mm (6 Fr)
Introducer size 2.0 mm (6 Fr) (minimum)
Usable length 80 cm (31.5 in)
Maximum inflation capacity 1.25 cm
Inflated balloon diameter 10 mm (0.4 in)
Recommended guide wire size 0.064 cm (0.025 in)
Materials

Catheter body Polyurethane

Balloon Latex

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Acknowledgements

1. Stanger P, Heymann MA, et al: Use the Swan-Ganz catheter in cardiac
catheterization of infants and children. Am Heart J 83:749-754, 1970.

2. Scwartz DC, West TD: Cardiac catheterization of infants and children. Heart
and Lung 3:407-414, 1974.

3. Lipp H, O’Donoghue K., Resekov L: Intracardiac knotting of a flow-directed
balloon catheter. N Engl J. Med 284:220, 1971.

4. Menasché P, Subayi JB, Piwnica A: Retrograde coronary sinus cardioplegia
for aortic valve operations. Ann Thorac Surg 49:556-64, 1990.

Special notice

Medtronic venogram balloon catheters are used in the extremely hostile
environment of the human body. Venogram balloon catheters may fail to function for
a variety of causes, including, but not limited to: medical complications, body

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rejection phenomena, or failure by breakage. In addition, despite the exercise of all
due care in design, component selection, manufacture, and testing prior to sale,
venogram balloon catheters may easily be damaged by improper handling or other
intervening acts. Consequently, no representation or warranty is made that failure or
cessation of function will not occur.

Medtronic disclaimer of warranty

For complete warranty information, see the accompanying warranty document.

Service

Medtronic employs highly trained representatives and engineers located
throughout the world to serve you and, upon request, to provide training to qualified
hospital personnel in the use of Medtronic products. Medtronic also maintains a
professional staff to provide technical consultation to product users. For more
information, contact your local Medtronic representative, or call or write Medtronic
at the appropriate telephone number or address listed on the back cover.

CE mark of conformity

The following CE mark of conformity applies to the Model 6215 venogram balloon
catheter.

Explanation of symbols

Table 2. Explanation of symbols on package labeling

Refer to the package labels to see which symbols apply to this product.

Conformité Européenne (European Conformity). This
symbol means that the device fully complies with appli­cable European Union acts.

For U.S. audiences only

Authorized representative in the European community

Date of manufacture

Manufacturer

Use by

Lot number

Reorder number

Serial number

Sterilized using ethylene oxide

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Table 2. Explanation of symbols on package labeling (continued)

Do not reuse

Do not use if package is damaged

Temperature limit

Open here

Consult instructions for use at this website

Package contents

Product documentation

Caution

Balloon

Contains or presence of natural rubber latex

Tip shape: Soft J

Contrast infusion

Balloon inflation

Guidewire

Use with

Outer diameter

8

Medtronic, Inc.

*M971371A001*

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Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Authorized Representative in the
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The Netherlands
[phone]

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[phone]

Australia

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Macquarie Park, NSW 2113
Australia
1800 668 670

Canada

Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
[phone]

Technical manuals

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© 2018 Medtronic
M971371A001 B
2018-01-07