Medtronic 49321 Instructions for Use

Cardioblate™ BP2 49321

Surgical Ablation Device

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, LigaSure, Medtronic, 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

49321

2 Product description

The Cardioblate BP2 surgical ablation device is a hand-held, single-use, bipolar, 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 to cool the tissue during RF energy delivery. The device is intended for intermittent operation.

The Cardioblate BP2 surgical ablation device (Model 49321) 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 Adjustable parallel jaws, 7 cm (2.76 in) in length 2 7 cm (2.76 in) electrodes embedded in a porous polymer, 5 cm (1.97 in) of which is malleable 3 300° rotation of jaw assembly 4 Malleable neck 5 Trigger 6 Trigger lock with raised thumb slide 7 Molded handle 8 Saline fluid delivery tubing 304.8 cm (120 in) in length with a female luer for connection to standard IV tubing systems 9 Electrical cable 304.8 cm (120 in) in length that terminates into a multi-pin connector

3 Indications for use

The Cardioblate BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

4 Contraindications

The Cardioblate BP2 surgical ablation device should not be used for:

• Patients that have active endocarditis at time of surgery

• Ablation in a pool of blood (for example, through a purse string suture on a beating heart) (Effects of this type of ablation are unknown.)

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 ablation of 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.

Remove the device from the patient before defibrillation.

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:

• Damage to the physiological conduction system

• Peripheral tissue ablation due to breach of insulation covering

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.

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 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. 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 radiofrequency energy to the tissue.

4. If only a bipolar 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.

5. 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 system, Model 49322) (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.

6. 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.

7. Open the IV line and squeeze the trigger to purge the system of air until fluid is seen coming from the electrodes on the bipolar device. Release the trigger to stop saline flow.

Figure 3.

1 7 cm (2.76 in) active electrodes 2 5 cm (1.97 in) malleable

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

Table 1. Compatible generator specifications Model VLFT10GEN

RF power output (bipolar mode)

RF power output frequency 434 ±10% kHz continuous sinusoid

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

8. With the Medtronic logo on the connector facing up, firmly insert the multi-pin connector into the LigaSure™/Bipolar receptacle on the energy platform front panel.

15 to 40 W

9. Shape the electrodes as required for the targeted tissue. Engage the trigger lock and squeeze the trigger to bring the electrodes together. Grip the electrodes with both hands to shape them at the same time. Ensure that the electrodes are aligned with no more than 4 mm distance between them.

10. Release the trigger lock by moving it backward and open the electrodes. Use the malleable neck and 300° roll to assist in positioning the electrodes on the targeted tissue.

11. Once the electrodes are correctly positioned, engage the trigger lock and squeeze the trigger to bring the electrodes in full contact with the tissue. The lock must be engaged to ensure accurate transmurality readings.

12. Confirm that the energy platform touchscreen indicates that the Cardioblate bipolar device is selected for use.

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

14. Before tissue ablation, squeeze the trigger and ensure that saline is flowing freely from the electrodes. 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.

Note: Suctioning of excessive fluid at the ablation site is recommended to increase the effectiveness of RF ablation. Note: In bipolar and enhanced bipolar modes, the energy platform monitors tissue impedance and adjusts the amount of power

delivered to the tissue between the active electrodes to create transmural lesions. Note: Refer to the energy platform user guide for information on high impedance and low impedance alert situations.

15. Activate energy delivery in the device using the Start RF button or the foot pedal provided with the energy platform. The energy flows between the electrodes.

Table 2. Anticipated energy delivery at various tissue thicknesses Tissue thickness (7 cm length) Energy delivered

1 mm 477 J ± 21 J 3 mm 511 J ± 41 J 5 mm 543 J ± 41 J

Note: The energy delivery duration is automatically limited by the energy platform.

16. The achievement of a transmural lesion in the bipolar mode is indicated by the energy platform tone changing from a beeping to a steady tone. The green transmurality symbol will appear on the screen next to the power output. RF energy will continue until the surgeon stops ablating or the maximum time-out is reached.

Note: To prevent the porous jaws from drying out and clogging, maintain the jaws immersed in saline or covered with a wet sponge between ablations.

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 Clinical data on conduction block

In vitro testing was conducted creating lesion sets on porcine atria. In vivo testing was performed on porcine cardiac tissue for the Cardioblate BP2 surgical ablation device. Transmural lesions were demonstrated with 95% confidence/95% reliability. The testing resulted in the following lesion dimensions:

n=3

Max transmurality depth (mm) 2.4 ±2.3 Lesion length (cm) 3.2 ±0.6 Lesion width (mm) 2.8 ±0.5

These results are consistent with a small, retrospective study conducted at 2 investigational centers of 69 patients during 2006-2007. Thirty-five of those patients received cardiac tissue ablation using irrigated RF energy. Of the 35 patients, 29 (82.9%) underwent conduction block assessment confirming transmurality of cardiac tissue lesions. The remaining 6 patients were not assessed.

10 The following disclaimer of warranty applies to United States customers only:

Disclaimer of Warranty

ALTHOUGH THE CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, HEREAFTER REFERRED TO AS “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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