Medtronic 49313 Instructions for Use

Cardioblate™ 49313

Surgical Ablation Pen

Instructions for Use

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.

Cardioblate, Covidien, Medtronic, Polyhesive, REM, TissueFect, Valleylab

Explanation of symbols on package labeling

Refer to the device labeling to see which symbols apply to this product.

Nonpyrogenic

Sterilized using ethylene oxide

Do not reuse

Do not resterilize

Do not use if package is damaged

Use-by date

Lot number

Quantity

Open here

Consult instructions for use at this website

For US audiences only

Upper limit of temperature

Humidity limitation

Date of manufacture

Catalog number

Manufacturer

Type CF applied part

Contains di(2-ethylhexyl)phthalate (DEHP)

Authorized representative in the European Community

1 Model

49313

2 Product description

The Cardioblate surgical ablation pen is a hand-held, single-use, monopolar, radiofrequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode tip to cool the tissue during RF energy delivery. The device is intended for intermittent operation.

The Cardioblate surgical ablation pen (Model 49313) is intended for use with the Covidien™ Valleylab™ FT10 FT series energy platform with TissueFect™ technology (Model VLFT10GEN) with software version 3.0.0 or higher.

Sterile, nonpyrogenic, disposable, single use only. Sterilized using ethylene oxide.

Rated accessory voltage: 382 V

Figure 1.

1 Molded acrylic handle with a silicone finger grip 2 Malleable stainless steel shaft with a silicone/fluoropolymer sheath 8.0 cm (3.15 in) in length 3 Rounded distal tip featuring multiple fluid openings 4 Antidrip transition piece that prevents fluid from running back onto the handle 5 Handle terminates into an integral saline fluid delivery tubing 304.8 cm (120 in) in length that is molded to the electrical cable and

detachable to the desired free length, with a female luer for connection to standard IV tubing systems 6 Handle also features an integral electrical cable 304.8 cm (120 in) in length that terminates into a multi-pin connector 7 Pinch clamp

3 Indications for use

The Cardioblate surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

4 Contraindications

The Cardioblate surgical ablation pen should not be used for patients that have active endocarditis at time of surgery.

5 Adverse effects

The following known adverse effects are associated with the use of the product:

• Abrasion

• Arrhythmia or EKG/ECG changes

• Burn

• Electrical shock

• Infection

• Ischemia

• Organ dysfunction (cardiac)

• Perforation

• Tissue damage

The following are possible adverse effects related to the creation of spot or linear lesions in cardiac tissue in combination with open heart surgery:

• Atrial lead dislodgement

• Atrioesophageal fistula

• Bleeding

• Cardiac perforation/tamponade

• Conduction disturbances (SA or AV node)

• Esophageal injury

• Extension of extracorporeal bypass

• Major complication (death)

• Mediastinitis

• Myocardial infarction in the context of cardiac ablation

• Pericarditis

• Phrenic nerve paralysis

• Pleural effusion

• Pulmonary vein stenosis

• Stroke or transient ischemic attack (TIA) post-ablation

• Vagal nerve injury

• Valve leaflet damage

6 Warnings

Do not activate the device if saline is not flowing freely. Applying radiofrequency energy without irrigation can result in charring, tissue desiccation, or insufficient ablation.

The device may be damaged before or during the procedure by improper handling or other intervening acts. If damaged, the device may fail to function properly, and may result in the following medical complications including, but not limited to:

• Tissue “popping” and perforation

• Damage to the physiological conduction system

• Peripheral tissue ablation due to breach of insulation covering

Remove the device from the patient before defibrillation.

No representation or warranty is made that failure or cessation of function of the device will not result in an adverse event, or that medical complications (including perforation of cardiac tissue) will not follow the procedure, or that the use of the device will in all cases restore adequate cardiac function.

This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. Multiple uses can result in the occlusion of the irrigation openings and affect the performance of the device. The energy platform has functionality to prevent the reuse of the device.

It is the responsibility of the hospital to ensure that the individuals assigned to operate this device are well-trained in the operation of the device and alert to potential problems.

Do not modify the device.

Do not use the device in the presence of flammable anesthetics, oxidizing gases, or flammable materials used for cleaning or disinfecting, as explosion may occur.

Use the device with caution in the presence of pacemakers or other active implanted devices. Interference produced by electrosurgical devices can affect the operation of the active implanted device or cause permanent damage to the active implanted device. Consult the active implanted device manufacturer or the responsible hospital department before using electrosurgical devices in patients with active implanted devices.

7 Precautions

Use caution to avoid trauma to tissues not within the intended area of ablation.

Follow recommended power settings for optimal ablation product performance.

Maximum storage temperature: 25°C (77°F)

Storage relative humidity: 5% to 85%, noncondensing

It is the responsibility of the user to dispose of the devices in accordance with local regulations and hospital procedures.

Applicable to products with phthalates identified on the product label: This product contains phthalates.

Inspect the device and device cable for breaks, cracks, nicks, and other damage before using the device. Do not use the device if any damage is found.

The use of smoke evacuation equipment is recommended. Smoke generated by electrosurgical devices is potentially harmful to patients and users.

8 Instructions for use

Warning: The device is sterile and nonpyrogenic. Inspect each package and device before use. Do not use the device if the use-by

date has passed or if the device or package is damaged. Using an expired or damaged device increases the risk of infection.

Warning: Failure to follow instructions may result in tissue damage, charring, tissue desiccation, and insufficient ablation.

Note: Read the energy platform user guide before using the device.

Note: If additional devices are to be used, refer to their specific instructions for use.

Note: Proper surgical procedures and techniques are necessarily the responsibility of the medical professional. Each surgeon must

evaluate the appropriateness of any procedure based on his or her own medical training and experience and the type of surgical procedure.

Note: Patient and procedure selection is solely a medical responsibility and the outcome is dependent on many variables including patient pathology, surgical procedures, and perfusion procedures.

Note: Sterile 0.9% normal saline, a commercially available pressure cuff, and an IV tubing set are required to use the device. These items are not included with the device.

1. Inspect the package and the device to ensure that the use-by date has not passed and damage has not occurred during shipping and handling.

Warning: Failure to use aseptic technique increases the risk of contaminating the disposables and harming the patient.

2. Open the package and transfer the device onto the sterile field using aseptic technique.

3. Apply a large patient return electrode (neutral electrode) to the patient according to the instructions in the energy platform user guide and the patient return electrode instructions for use. Choose an application site for the patient return electrode that is as close to the heart as possible and that allows the entire area of the patient return electrode to make secure contact with the patient’s skin. The recommended application site is the patient’s back.

Note: Only use the following patient return electrodes with the device:

Model Description

E7507 Valleylab™ REM™ Polyhesive™ Adult Patient Return Elec-

trode E7507DB Valleylab REM Polyhesive Adult Patient Return Electrode E7508 Valleylab REM Polyhesive Adult Cordless Patient Return Elec-

trode E7509 Valleylab REM Polyhesive Adult Cordless Patient Return Elec-

trode E7509B Valleylab REM Polyhesive Adult Cordless Patient Return Elec-

trode

4. Connect the patient return electrode to the energy platform according to the instructions in the energy platform user guide and the patient return electrode instructions for use.

5. Carefully uncoil the saline delivery tubing and the electrical cable to avoid kinking and tangling. Note: 0.9% normal saline is required because it provides a low impedance pathway for the RF energy to the tissue.

6. If only a monopolar device is being used, attach the female luer connector of the saline delivery tubing to an IV tubing set and a 1000 mL bag of sterile 0.9% normal saline.

7. If both a bipolar device and a monopolar device are being used, perform the following steps:

a. Remove the sterile caps from a “Y” connector (provided with the Cardioblate BP2 and LP systems, Models 49322 and

49342) (Figure 2). b. Attach the female luer connectors of each saline delivery line to the “Y” connector. c. Connect the “Y” connector to an IV tubing set and a 1000 mL bag of sterile 0.9% normal saline.

Figure 2.

8. Insert the 1000 mL bag of 0.9% normal saline into a commercially available pressure cuff and inflate the cuff to between 150 and 300 mmHg.

9. Purge the system of air until fluid is seen coming from the openings on the distal tip of the device (Figure 3). Clamp off the tubing set until ready for use.

Figure 3.

Note: Only connect the device to RF generators with the following specifications:

Table 1. Compatible generator specifications

Model VLFT10GEN RF power output

1 to 50 W (manually variable)

(monopolar mode) RF power output frequency 434 ±10% kHz continuous sinusoid

Note: The rated accessory voltage is limited by the energy platform.

10. With the Medtronic logo on the connector facing up, firmly insert the multi-pin connector into the Monopolar 2 receptacle on the energy platform front panel.

11. Confirm that the energy platform touchscreen indicates that the Cardioblate monopolar device is selected for use.

12. Position the device electrical cable to avoid contact with the patient or other leads.

13. Before tissue ablation, open the IV line and ensure that saline is flowing freely from the openings in the distal tip of the device. Warning: Do not activate the device if saline is not flowing freely. Applying radiofrequency energy without irrigation can result in

charring, tissue desiccation, or insufficient ablation. Warning: Suction excessive fluid at the ablation site before activating the device. Failure to suction excessive fluid can result in

unintended burns to the patient.

Caution: The intensity should be set as low as necessary to achieve the desired effect. Note: Refer to the energy platform user guide for information on high impedance and low impedance alert situations. Note: Ideal power settings should be determined by the surgeon during tissue ablation.

14. Set the power setting on the energy platform to between 20 and 30 W.

15. Activate energy delivery in the device using the Start RF button or the foot pedal provided with the energy platform. Gently drag the distal tip of the device across the intended intracardiac tissue under direct visualization. The energy flows between the tip and the patient return electrode on the patient’s body.

Warning: Do not dwell in an intended tissue area too long. This can lead to sudden tissue “popping” and perforation.

16. The lesion becomes visible as a white coloration on the tissue. Move the tip in an oscillating motion at a recommended speed of 1 cm/s. The surgeon determines the depth, width, and location of the ablation.

17. When the surgical procedure is complete, disconnect the device from the energy platform and discard the device in accordance with local regulations and hospital procedures.

9 In vitro data on lesion depths

In vitro testing was conducted using a Valleylab FT10 energy platform (Model VLFT10GEN) and Cardioblate surgical ablation pens to create lesions on bovine myocardium. The testing was performed at 4 combinations of power and time, which resulted in the lesion depth intervals calculated at 95% confidence in Table 2. Results may vary in clinical use due to user technique and cardiac tissue type.

Table 2. Anticipated lesion depth at various power levels 95% confidence interval for 10 s oscil-

lation (1 cm)

2.1 to 2.7 mm 3.3 to 4.0 mm 20 W

2.1 to 2.8 mm 5.2 to 6.6 mm 30 W

95% confidence interval for 20 s oscillation (1 cm)

Power at 300 mmHg pressure on saline irrigation

10 Disclaimer of warranty

The warnings contained in the product labeling provide more detailed information and are considered an integral part of this disclaimer of warranty. Although the product has been manufactured under carefully controlled conditions, Medtronic has no control over the conditions under which this product is used. Medtronic, therefore, disclaims all warranties, both express and implied, with respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct, incidental, or consequential damages caused by any use, defect, failure, or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No person has any authority to bind Medtronic to any representation or warranty with respect to the product.

The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this disclaimer of warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term held to be invalid.

Medtronic, Inc.

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