Medtronic 209F3 Technical Manual

Freezor™ MAX 209F3, 209F5

Cardiac Cryoablation Catheter

Technical Manual

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

Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks
(“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a
Medtronic entity in the United States and/or in other countries.

Arctic Front™, CryoConsole™, Freezor™

Explanation of symbols

Lot number

Reorder number

Use by

Sterilized using ethylene oxide

Do not re-use

Do not resterilize

Do not use if package is damaged

Package contents

Consult instructions for use

Fragile: handle with care

Keep dry

Product documentation

Humidity limitation

Storage temperature

Transit temperature

Cardiac Cryoablation Catheter

Open here

Manufacturer

Date of manufacture

Manufactured in

Model number

Single sterile barrier system with protective packaging inside

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1 Description

The Freezor MAX Cardiac Cryoablation Catheter is a flexible, steerable catheter used to ablate
cardiac tissue. It is used together with the CryoConsole and related components. The tip of the
Freezor MAX catheter reaches cryoablation temperatures when refrigerant is injected from the
CryoConsole to the tip of the catheter. The catheter tip has an integrated type T thermocouple for
temperature reading capability. The catheter is introduced into the vasculature by traditional
minimally invasive techniques. The Freezor MAX catheter is available in 2 models, as described
in the following table:

Model Curves available

209F3 (medium) blue curve 55 mm
209F5 (long) orange curve 66 mm

For details about the CryoConsole and how to use it with the catheter to perform cryoablation
procedures, see the CryoConsole Operator Manual.

1.1 Contents of package

The Freezor MAX Cardiac Cryoablation Catheter is supplied sterile. The package contains the
following items:

• 1 Freezor MAX Cardiac Cryoablation Catheter

• product documentation

2 Indications for use

The Freezor MAX Cardiac Cryoablation Catheter is used as an adjunctive device in the
endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than
6 months) in conjunction with the Arctic Front™ family of Cardiac Cryoablation Catheters for the
following uses:

• gap cryoablation to complete electrical isolation of the pulmonary veins

• cryoablation of focal trigger sites

• creation of ablation line between the inferior vena cava and the tricuspid valve

3 Contraindications

The Freezor MAX Cardiac Cryoablation Catheter is contraindicated in patients with the following
conditions:

• active systemic infections

• cryoglobulinemia

• intracardiac mural thrombus

• myxoma

• interatrial baffle or patch

The Freezor MAX Cardiac Cryoablation Catheter is also contraindicated in patients with a body
mass under 4.4 kg.

4 Warnings and precautions

Anticoagulation therapy – Administer appropriate levels of peri-procedural anticoagulation

therapy for patients undergoing left-sided and transseptal cardiac procedures, and for selected
patients undergoing right-sided procedures. Administer anticoagulation therapy before and after
the procedure according to the hospital standards. The Freezor MAX Cardiac Cryoablation
Catheter was not studied for the safety of changes in anticoagulation therapy in patients with
paroxysmal atrial fibrillation.

AV conduction – Closely monitor AV conduction during cryo energy delivery near the AV node
due to possible risk of complete atrioventricular (AV) block. Immediately terminate energy delivery
if partial or complete AV block is noted.

Biohazard disposal – Discard all used catheters and sterile components in accordance with
hospital procedures.

Cardioversion/defibrillation during ablation procedure – Disconnect the catheter’s electrical
connection prior to cardioversion/defibrillation. Failure to do so may trigger system messages
indicating a need for catheter exchange.

Catheter handling –

• Use extreme care when manipulating the catheter. Lack of careful attention can result in injury
such as perforation or tamponade.

• Do not use excessive force to advance or withdraw the catheter, especially if resistance is
encountered.

• Do not use the catheter if it is kinked, damaged, or cannot be straightened.

• Straighten the cooling segment before inserting or withdrawing the catheter.

• Do not at any time preshape or bend the catheter shaft or cooling segment. Bending or kinking
the catheter shaft may damage internal structures and increase the risk of catheter failure.
Prebending of the distal curve can damage the catheter.

• Catheter advancement should be performed under fluoroscopic guidance or other
appropriate visualization technique.

Catheter integrity – Do not use the catheter if it is kinked or damaged. If the catheter becomes
kinked or damaged while in the patient, remove it and use a new catheter. Prior to injecting, the
physician should ensure that there is no kink in the catheter.

Catheter positioning around the chordae tendineae – Avoid positioning the catheter around
the chordae tendineae, as this increases the likelihood of catheter entrapment within the heart,
which may necessitate surgical intervention or repair of injured tissues.

Coronary vessels – Cryoablation involving coronary vessels has been associated with
subsequent clinically significant arterial stenosis. Care should be taken to minimize unnecessary
contact with coronary vessels during cryoablation.

Cryoablation near prosthetic heart valves – Do not pass the catheter through a prosthetic
heart valve (mechanical or tissue). The catheter may become trapped in the valve, damaging the
valve and causing valvular insufficiency or premature failure of the prosthetic valve.

Cryoadhesion – Do not pull on the catheter, sheath, umbilical cables, or console while the
catheter is frozen to the tissue, as this may lead to tissue injury.

Do not resterilize – Do not resterilize this device for the purpose of reuse. 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.

Embolism risk – Introducing any catheter into the circulatory system entails the risk of air or gas
embolism, which can occlude vessels and lead to tissue infarction with serious consequences.
Always advance and withdraw components slowly to minimize the vacuum created and therefore
minimize the risk of air embolism.

Environmental limits – Perform cryoablation procedures only within the environmental
parameters. Operating outside these parameters may prevent the start or completion of a
cryoablation procedure.

Fluid incursion – Do not expose the catheter handle or coaxial and electrical connectors to fluids
or solvents. If these components get wet, the cryoablation system may not function properly, and
connector integrity may be compromised.

Fluoroscopy during catheter placement – The use of fluoroscopy during catheter ablation
procedures presents the potential for significant x-ray exposure to both patients and laboratory
staff. Extensive exposure can result in acute radiation injury and increased risk for somatic and
genetic effects. Only perform catheter ablation after giving adequate attention to the potential
radiation exposure associated with the procedure, and taking steps to minimize this exposure.
Give careful consideration before using the catheter in pregnant women.

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

Improper connection – Do not connect the cryoablation catheter to a radiofrequency (RF)
generator or use it to deliver RF energy. Doing this may cause catheter malfunction or patient
harm.

Induced arrhythmias – Catheter procedures may mechanically induce arrhythmias.

Leakage current from connected devices – Use only isolated equipment (IEC 60601-1 Type

CF equipment, or equivalent) with the CryoConsole and catheters or patient injury or death may
occur.

Other catheters, devices, or wires – Avoid catheter entanglement with other catheters,
devices, or wires. Such entanglement may necessitate surgical intervention.

Post-ablation period – Closely monitor patients undergoing cardiac ablation procedures during
the post-ablation period for clinical adverse events.

Pressurized refrigerant – The catheter contains pressurized refrigerant during operation.
Release of this gas into the circulatory system due to equipment failure or misuse could result in
gas embolism.

Qualified users – This equipment should be used only by physicians that perform cardiac
ablation.

Required use environment – Cryoablation procedures should be performed only in a fully
equipped facility.

RF ablation – Before powering up an RF generator or applying RF energy, disconnect the
cryoablation catheter from the CryoConsole to avoid an error message and unnecessary catheter
replacement.

Safety in magnetic resonance imaging (MRI) not evaluated – The Freezor MAX catheter has
not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The
safety of the Freezor MAX catheter in the MR environment is unknown (such as any heating,
migration, or image artifact). Scanning a patient during the use of this device may result in patient
injury.

Sterile package inspection – Visually inspect all sterile-barrier packaging before use. If the
device is damaged or the integrity of the sterilization barrier has been compromised, do not use
the product. Contact your Medtronic representative for return information.

System compatibility – The Medtronic cryoablation catheters, refrigerant tanks, and other
Medtronic CryoConsole components should only be used with the Medtronic CryoConsole.

Transaortic approach – Use adequate fluoroscopic visualization or other appropriate
visualization technique during a transaortic approach to avoid placing the ablation catheter within
the coronary vasculature. Catheter placement within the coronary vasculature may cause
vascular injury.

5 Clinical studies

Information regarding clinical studies that are applicable to Freezor MAX are available on the
Medtronic Manual Library website:

1. Point your browser to www.medtronic.com/manuals.

2. Select the geography and language, and then search by product name for Freezor MAX.
The catheter technical manual and any applicable studies are listed. If you do not have web
access, you can order printed copies of the clinical study summaries from your Medtronic
representative or by calling the toll-free number located on the back cover.

6 Adverse events

Potential adverse events associated with cardiac catheter cryoablation procedures include, but
are not limited to, the following conditions:

• Access site complications (such as
hematoma, infection, thrombosis, ecchy­mosis, AV fistula, bleeding from puncture
site, hemorrhage)

• Arrhythmia (such as atrial fibrillation, atrial
flutter, tachycardia)

• Cardiac arrest

• Chest discomfort, pain or pressure

• Coronary artery spasm

• Coronary artery stenosis

• Damage to heart tissue or vasculature

• Death

• Endocarditis

• Entrapment

• Esophageal damage (such as atrio­esophageal fistula)

• Heart block, requiring permanent pace­maker

• Hemothorax

• Infection

• Perforation of venous, cardiac or surround­ing tissue

• Pericardial effusion, tamponade

• Pericarditis

• Phrenic nerve injury

• Pleural effusion

• Pneumothorax

• Pseudoaneurysm

• Pulmonary edema

• Pulmonary embolism

• Stroke

• Tissue infarction (such as myocardial in­farction or renal infarction)

• Thrombus

• Transient ischemic attack (TIA)

• Vagal nerve injury (such as gastroparesis)

• Vasovagal reaction

7 Instructions for use

7.1 Connecting the catheter

For more detailed instructions refer to the CryoConsole Operator’s Manual.

1. Connect the non-sterile auto connection box to the CryoConsole.

2. Connect the Freezor MAX catheter to a sterile coaxial umbilical cable and a sterile electrical
umbilical cable in a dry environment.

3. Connect the coaxial umbilical cable to the CryoConsole and connect the electrical umbilical
cable to the connection box.

7.2 Cryoablation

For more detailed instructions refer to the CryoConsole Operator’s Manual.

Note: Use adequate filtering on the recording system to allow continuous monitoring of the
surface electrocardiogram (ECG) during cryoapplications.

1. Before introducing the Freezor MAX catheter into the patient, test the deflection mechanism
by pulling back the lever on the handle to ensure that it is operational.

2. Using an aseptic technique, create a vascular access with a 10 Fr (minimum) introducer or
sheath, and insert the Freezor MAX catheter.

Note: The catheter tip can be deflected to facilitate positioning by using the lever on the
handle to vary tip curvature. Pulling the thumb knob back causes the catheter tip to bend;
pushing the knob forward causes the tip to straighten.

3. Set the treatment time on the CryoConsole screen.
Note: The preset duration is 240 s and the maximum time is 480 s. The time can be adjusted

before or during the injection of refrigerant.

4. Under fluoroscopic guidance or other appropriate visualization technique, position the tip of
the Freezor MAX catheter at the endocardial site for the cryoablation, ensuring good tip
contact. As needed, deflect the catheter tip to facilitate positioning by using the lever on the
handle to vary tip curvature.

5. Perform the cryoablation.

6. Wait for the cryoablation phase to complete (at the end of the preset time).

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Note: Do not manipulate the device while it is frozen to the tissue.

7. Remove the catheter from the point of cryoablation.

8. If needed, perform additional cryoablation treatments.

9. Remove the catheter from the patient.
Note: Use the deflection mechanism on the sheath handle to straighten the sheath. Use the

deflection mechanism on the catheter handle to straighten the catheter.

8 Specifications

Significant physical and performance characteristics are included in the table below.

Description

Catheter shaft outer diameter 3.0 mm (9 Fr; 0.118 in)
Tip length 8 mm (0.33 in)
Curves available

209F3 55 mm (2.17 in)

209F5 66 mm (2.60 in)
Effective catheter length 90 cm (35.4 in)
Number of electrodes 4
Electrode spacing 3.5 mm (0.14 in), 5.0 mm (0.20 in), 2.0 mm

Number of thermocouples 1
Refrigerant flow 3500 ± 200 sccm
Cryomapping Not available
Compatibility

Console Medtronic CryoConsole

Electrical connection cable Medtronic electrical umbilical cable (2035U,

Coaxial connection cable Medtronic coaxial umbilical cable (203CX,

Introducer sheath 3.3 mm minimum (10 Fr, 0.13 in)
Environmental parameters

Recommended transit temperature -35°C to 58°F (-31°F to 136°F); up to 85%

Recommended storage temperature 15°C to 30°C (59°F to 86°F)

Operation 15°C to 30°C (59°F to 86°F) at altitudes less

Sterilization single use, sterile device, ethylene oxide

a

The specific model number for the compatible CryoConsole may vary based on geography.
Contact your local Medtronic representative for additional information.

Specification

(0.08 in)

a

2035UC)

203CXC)

relative humidity (non-condensing)

than 2400 m (8000 ft) above sea level at humid­ity between 30% and 75%

9 Medtronic limited warranty

For complete warranty information, see the accompanying limited warranty document.

10 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.

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Medtronic, Inc.

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Minneapolis, MN 55432

USA

www.medtronic.com

[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
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Tachycardia: [phone]

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2022-03-30