Adverse Events; Connecting The Catheter - Medtronic ARCTIC FRONT 2AF231 Manual Del Usuario

Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the
sterile packaging or catheter is damaged, do not use the catheter. Contact your Medtronic
representative.
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.
Required use environment – Cryoablation procedures should be performed only in a fully
equipped facility.
Qualified users – This equipment should be used only by or under the supervision of
physicians trained in left atrial cryoablation procedures.
Fluid incursion – Do not expose the catheter handle or coaxial and electrical connectors to
fluids or solvents. If these components get wet, the Arctic Front Cryocatheter System may
not function properly, and connector integrity may be compromised.
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.
Anticoagulation therapy – Administer appropriate levels of peri-procedural
anticoagulation therapy for patients undergoing left-sided and transseptal cardiac
procedures. Administer anticoagulation therapy during and post-procedure according to the
institution's standards.
Pulmonary vein narrowing or stenosis – Catheter ablation procedures inside or near
pulmonary veins may induce pulmonary vein narrowing and/or stenosis. The occurrence of
this complication may necessitate percutaneous angioplasty or surgical intervention.
Frequent flushing of the guide wire lumen – Flush the guide wire lumen initially and then
regularly to prevent coagulation of blood in the lumen. Flush the guide wire lumen with saline
after each contrast injection.
Steerable sheath compatibility – Use only the 12 Fr FlexCath Steerable Sheath with the
Arctic Front Cardiac CryoAblation Catheter. Using another sheath may damage the catheter
or balloon segment.
Balloon inflation – Do not inflate the balloon inside the sheath. Always verify with
fluoroscopy that the balloon is fully outside the sheath before inflation to avoid catheter
damage.
Environmental limits – Perform cryoablation procedures only within the environmental
parameters. Operating outside these parameters may prevent the start or completion of a
cryoablation procedure.
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.

5 Adverse events

Potential adverse events associated with cardiac catheter cryoablation procedures include,
but are not limited to, the following conditions:
Anemia
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Anxiety
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Atrial flutter
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Back pain
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Bleeding from puncture sites
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Blurred vision
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Bradycardia
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Bronchitis
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Bruising
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Cardiac tamponade
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Cardiopulmonary arrest
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Cerebral vascular accident
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Chest discomfort, pain, pressure
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Cold feeling
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Cough
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Death
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Diarrhea
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Dizziness
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Esophageal damage
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6 Instructions for use

6.1 Connecting the catheter

To connect the catheter, follow these steps. (For more detailed instructions, see the
CryoConsole Operator's Manual.)
1. Connect the connection box to the CryoConsole.
2. Connect the Arctic Front cryocatheter to a sterile coaxial umbilical cable and a sterile
electrical umbilical cable.
3. Connect the coaxial umbilical cable to the CryoConsole and connect the electrical
umbilical cable to the connection box.
6.2 CryoAblation
To use the catheter for a cryoablation procedure, follow these steps. (For more detailed
instructions, see the CryoConsole Operator's Manual.)
Note: Prior to introducing the Arctic Front into the patient, test the deflection mechanism by
pulling on the lever on the handle to ensure it is operational.
Note: Always use the lever on the handle to straighten the distal segment before insertion
or withdrawal of the catheter.
1. Using an aseptic technique, create a vascular access with an appropriate introducer.
Obtain left atrial, transseptal access using a transseptal sheath and needle.
2. Remove the transseptal sheath leaving the guide wire positioned preferably in the LSPV.
3. Advance the FlexCath sheath and dilator into the left atrium.
4. Slowly remove the guide wire and dilator from the sheath.
5. Slowly advance Arctic Front with a 0.032" to 0.035" guide wire through the entire length
of the FlexCath sheath.
6. Set the treatment time on the CryoConsole screen.
7. Inflate the balloon in the left atrium.
8. Position the catheter at the ostium of the target pulmonary vein.
9. Verify the balloon position by injecting a mixture of 50/50 contrast/saline into the catheter
guide wire lumen port. Be sure to flush the guide wire lumen with saline after each
contrast injection.
Note: The preset ablation duration is 240 seconds.
10.Perform the cryoablation.
11. Wait for the cryoablation phase to complete (at the end of the preset time). The balloon
remains inflated and the Thawing phase begins.
12.During the Thawing phase, watch the temperature indicator on the screen. When it
reaches 10 °C, advance the blue tensioning button on the catheter handle. Maintain
pressure on the tensioning button until the balloon deflates. The balloon deflates
automatically when the temperature reaches 20 °C.
Note: Advancing the tensioning button during balloon deflation causes the balloon to
extend to maximum length and to wrap tightly.
13.If needed, perform additional treatments by positioning the guide wire in different
branches of the same pulmonary vein.
6 English Arctic Front Technical Manual
Fatigue
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Fever
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Headache
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Hemoptysis
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Hypotension, hypertension
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Lightheadedness
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Myocardial infarction
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Nausea/vomiting
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Nerve injury
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Pericardial effusion
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Pulmonary vein stenosis
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Shivering
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Shortness of breath
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Sore throat
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Tachycardia
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Transient ischemic attack
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Urinary infection
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Vasovagal reaction
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Visual changes
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