Medtronic 60813 Instructions for Use

CARDIOBLATE

Surgical Ablation Pen

60813

®

Instructions for Use

Caution: Federal law (USA) restricts

this device to sale by or on the order of a
physician.

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

Use By

Lot Number

Quantity

Open Here

Consult Instructions for Use

For US Audiences Only

Upper Limit of Temperature

Humidity Limitation

Date of Manufacture

Catalog Number

Manufacturer

Contains di(2-ethylhexyl)phthalate (DEHP)

Authorized Representative in the European Community

Do not use if package is damaged

Type CF Applied Part

1

Cardioblate® Surgical Ablation Pen

7

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) long

3. Rounded distal tip features multiple fluid openings

4. Antidrip transition piece prevents fluid from running back onto the
handle

5. Handle terminates into an integral saline fluid delivery tubing

304.8 cm (10 ft) 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 (10 ft) in
length that terminates into a multi-pin connector

7. Pinch clamp

2

CARDIOBLATE

®

Surgical Ablation Pen

Model

60813

Description

The Cardioblate® Surgical Ablation Pen is a hand-held, single-use,
monopolar, radiofrequency ablation device for use in cardiac surgery. It

a saline irrigation system to deliver fluid at the contact point between

has
the tissue and electrode tip to cool the tissue during radiofrequency
energy delivery. The device is intended for intermittent operation.

Sterile, nonpyrogenic, disposable, single use only.

Indications for Use

The Cardioblate® Surgical Ablation Pen is intended to ablate cardiac
tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate® Surgical Ablation Pen should not be used for patients
that have active endocarditis at time of surgery.

Adverse Effects

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

■

tissue perforation

■

extension of extracorporeal bypass

■

perioperative heart rhythm disturbances (atrial and/or
ventricular)

■

postoperative embolic complications

■

pericardial effusion or tamponade

■

injury to the great vessels

■

valve leaflet damage

■

conduction disturbances (SA/AV node)

■

acute ischemic myocardial event

■

thrombus formation

■

nerve damage

■

unintentional burns

■

pericarditis

■

pleural effusion

■

esophageal perforation

■

death

■

coronary sinus perforation

■

coronary artery spasm

■

atrial lead dislodgement

■

hypotension

■

cerebrovascular accident

■

transient ischemic attack

■

blood loss

Warnings

Do not activate ablation if saline is not flowing freely. Cooling of the
outer tissue prevents the charring and tissue desiccation that may
occur when applying radiofrequency energy without irrigation.

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

Instructions for Use English 3

■

damage to the physiological conduction system

■

peripheral tissue ablation due to breach of insulation
covering

The device shall be removed from the patient before defibrillation.

representation or warranty is made that failure or cessation of function

No
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.

Precautions

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

of a physician.
Proper surgical procedures and techniques are the responsibility of the

medical professional. Each surgeon must evaluate the appropriateness
of any procedure based on their own medical training and experience,
and the type of surgical procedure.

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

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

Make certain that saline fluid flows from the distal tip ports during use.
Follow recommended power settings (step 8) for optimal ablation product

performance.
Separation of tip from tissue contact during activation of RF ablation will

result in high impedance shutdown switching the generator power
condition to STANDBY. Three short audible alarm beeps from the
generator indicate a high impedance occurrence. Refer to the Cardioblate
generator technical manual for reset instructions.

Maximum storage temperature: 40°C (104°F)
Storage relative humidity: 5% to 85%, noncondensing
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 device’s performance.

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

Due to the presence of phthalates in the product, the clinician must weigh
the medical benefits of product use against the drawbacks of phthalate
exposure for male children and pregnant or nursing women.

Connections to External Devices

Note: Do not attempt to reuse the ablation device with the Cardioblate

generator. The generator has the capability to detect previously used
ablation devices and will not allow their reuse.

1. Connection to the Cardioblate generator is as follows:
a. Position the multi-pin connector of the pen so the alignment

indicator matches the monopolar generator port indicator.

b. Insert the multi-pin connector of the pen into the device port on

the generator until it locks in place. Do not force the connection.
Note: Connect to RF generators (only IEC / EN 60601-1

Type CF) with the following specifications:

RF power output
setpoint/limit

Model 60880/60890 Model 68000

25 - 50 W
(manually variable)

25 - 50 W
(manually varia-

ble)

4 Instructions for Use English

RF power output
frequency

Maximum RF volt­age, between elec­trodes

Note: If additional devices are to be used, refer to their specific
directions for connection information.

Sterile normal saline, commercially available pressure bag, and IV

2.
tubing set are required.

Model 60880/60890 Model 68000

479 - 489 kHz 468 - 478 kHz

159 Vrms 180 Vrms ±10%

Instructions for Use

1. Inspect the package and device to ensure the expiration date has not
passed and no damage occurred to the device during shipping and
handling. Do not use the device if the packaging or device is damaged
or if the expiration date has elapsed. Open the package and transfer
the device onto the sterile field utilizing an aseptic technique.

2. Place a large indifferent electrode pad with electrical cable securely
on the back of the patient’s body. (Refer to generator manual and
indifferent electrode instructions for use for specific instructions on
electrode placement and skin care.)

3. Attach the electrical cable from the indifferent electrode securely to
the appropriate patient grounding connection site on the Cardioblate
generator. (Refer to the Cardioblate generator technical manual.)

4. Uncoil both the saline delivery tubing and the electrical cable carefully
to avoid kinking and tangling.

5. Attach the saline delivery tubing female luer connector to an IV tubing
set and sterile normal saline bag. (0.9% normal saline is
recommended because it provides a low impedance pathway for the
radiofrequency energy to the tissue.)

If both a bipolar and monopolar device are being used, attach the
female luer of both devices to the “Y” connector (Model 10004D)
provided. Then insert the IV line into the “Y” connector.

6. Place the sterile normal saline bag into the pressure bag. Inflate the
pressure bag to between 150 and 300 mm Hg. Purge the system of
air until fluid is seen coming from the openings on the distal tip of the
device (Figure 2). Clamp off tubing set until ready for use.

Figure 2.

7. Attach

8. Prior to tissue ablation:

the pen electrical cable to the Cardioblate generator connector

per instructions outlined in “Connections to External Devices.”

a. Open the IV line and make certain that saline is flowing freely out

of the openings in the distal tip of the device. Continuous flow of
saline is necessary during ablation to cool the outer tissue.
Cooling of the outer tissue prevents charring and tissue
desiccation and allows radiofrequency energy to be delivered
deeper into the tissue to more effectively create transmural
lesions.

b. Set the radiofrequency ablation generator to the POWER mode

and set the power between 20-30 watts maximum output. Ideal
power settings should be determined by the surgeon during
tissue ablation.

Instructions for Use English 5

9. The distal tip of the device is dragged gently across the targeted
intracardiac tissue under direct visualization by the surgeon. The
current is activated in the device using the foot switch provided with

Cardioblate generator. The current flows between the ablation tip

the
and the large indifferent electrode on the patient’s body.

10. The lesion becomes visible as a white coloration on the tissue. The
tip is moved in an oscillating motion at a recommended speed of
1 cm/sec. The surgeon will determine depth, width, and location of
the ablation.

11. Do not dwell in a target area too long; sudden tissue “popping” and/or
perforation may occur.

12. Upon completion of the surgical procedure, disconnect the device
and indifferent electrode from the Cardioblate generator and discard.

Clinical Data on Conduction Block

In vitro testing was conducted creating lesion sets on bovine atria. In vivo
testing was performed on porcine cardiac tissue for the Cardioblate
Surgical Ablation Pen. Transmural lesions were demonstrated with a
95/95 confidence level. The testing resulted in the following lesion
dimensions:

Table 1. Anticipated Lesion Depth at Various Power Levels

95% Confidence

interval for 10 sec-

ond oscillation,

1 cm

2.3 – 3.5 mm 3.5 – 4.4 mm 20

2.9 – 3.7 mm 4.7 – 5.7 mm 30

These results are consistent with a small, retrospective study conducted

two investigational centers of 69 patients during 2006-2007. Thirty-five

at
of those patients received cardiac tissue ablation using irrigated
radiofrequency (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.

95% Confidence

interval for 20 sec-

ond oscillation,

1 cm

Power (W) @

150 - 300 mm Hg pres-

on saline irrigation

sure

6 Instructions for Use English

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

Disclaimer of Warranty

ALTHOUGH THE CARDIOBLATE® SURGICAL ABLATION PEN,
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
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
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY

of Warranty shall not be affected, and all rights and obligations

The following disclaimer of warranty applies to customers
outside the United States:

Disclaimer of Warranty

ALTHOUGH THE CARDIOBLATE® SURGICAL ABLATION PEN,
HEREAFTER REFERRED TO AS “PRODUCT” HAS BEEN
CAREFULLY DESIGNED, MANUFACTURED AND TESTED PRIOR
TO SALE, THE PRODUCT MAY FAIL TO PERFORM ITS INTENDED
FUNCTION SATISFACTORILY FOR A VARIETY OF REASONS. THE
WARNINGS CONTAINED IN THE PRODUCT LABELING PROVIDE
MORE DETAILED INFORMATION AND ARE CONSIDERED AN
INTEGRAL PART OF THIS DISCLAIMER OF WARRANTY.
MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH
EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT.
MEDTRONIC SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR
CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, OR
FAILURE OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON
WARRANTY, CONTRACT, TORT OR OTHERWISE.

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
by any court of competent jurisdiction to be illegal, unenforceable or in
conflict with applicable law, the validity of the remaining portion of the
Disclaimer
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

of Warranty shall not be affected, and all rights and obligations

Instructions for Use English 7

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Medtronic
M940535A001 Rev. 1B