Medtronic 990066 Technical Manual

ACHIEVE™ 990063-015,
990063-020, 990066

Mapping Catheter/Cable

Technical Manual

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

The following are trademarks or registered trademarks of

EC REP

Medtronic in the United States and possibly in other countries:
Achieve, Medtronic

Explanation of symbols

The following list of symbols and abbreviations applies to various products. Refer to the package labels to see
which of these apply to this product.

Lot number

Reorder number

Use by

Sterilized using irradiation (catheter)

Cable

Sterilized using ethylene oxide (cable)

Do not reuse

Do not resterilize

t

Do not use if package is damaged

Do

Package contents

Consult instructions for use

Product documentation

Keep dr y

Keep away from heat

Manufacturer

Authorized representative in the European Community

Conformité Européenne (European Conformity)
This symbol means that the device fully complies with
European Directive 93/42/EEC.

For US audiences only

1 Description

2

1

3.3 Fr

1.1 mm (0.043”)

15 mm

20 mm

6 mm

2

1

2

1

4 mm

This document is intended to be used with the Achieve Mapping Catheter and Cable.
The Achieve Mapping Catheter is an intra-cardiac electrophysiology (EP) recording catheter
and can be used for cardiac stimulation during electrophysiology studies.
The Achieve Mapping Catheter is compatible for use with the Medtronic Arctic Front
CryoAblation Catheter, and may be used to support and position the Arctic Front Catheter.
Refer to the Arctic Front Technical Manual for additional instructions for use.

1 Overall length
2 Effective length

Figure 1. Achieve Mapping Catheter dimensions
The distal mapping section of the Achieve is a circular loop with eight evenly spaced
electrodes to map electrical conduction between the left atrium and the pulmonary veins.

165 cm
146 cm

165 cm
146 cm

990063-015 990063-020

990063-015 990063-020

1 Distance between electrodes
2 Loop diameter

Figure 2. Achieve Mapping Catheter loop
The Achieve Mapping Catheter should only be used with the Cable (Model 990066) which
interfaces with standard EP recording equipment.

1.1 Contents of packag e

The Achieve Mapping Catheter is supplied sterile. The package contains the following items:

■

1 Achieve Mapping Catheter

■

product documentation

2 Indications for use

The Achieve Mapping Catheter is indicated for multiple electrode electrophysiological
mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve
Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

3 Contraindications

The Achieve Mapping Catheter is contraindicated as follows:

■

For use as an ablation device

■

For use with transeptal sheaths featuring side holes larger than 1.00 mm in diameter

■

Retrograde approach
Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease
makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a
high risk of death, as in the following conditions:

■

An active systemic infection

■

Left atrial thrombus

■

Pulmonary vein stents

■

Prosthetic heart valve (tissue or mechanical)

■

Myxoma

■

Interatrial baffle or patch

■

Conditions where the manipulation of the catheter within the heart would be unsafe

■

Acute myocardial infarction

4 Warnings and precautions

For single use only – This catheter and cable are intended only to be used once for a single

patient. Do not reuse, reprocess, or resterilize these devices for purpose of reuse. Reuse,
reprocessing, or 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.
Do not resterilize – Do not resterilize the catheter or cable for purpose of reuse.
Resterilization 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.
Qualified users – This equipment should be used only by or under the supervision of
physicians trained in cardiac catheterization procedures.
Device disposal – Dispose of catheter and cable according to hospital biohazard
requirements.
Expiration date – Check to verify the catheter and cable are within the expiration date. Do
not use if the product date has expired.
Sterile package inspection – Inspect the sterile packaging prior to use. If the sterile
packaging of the device is damaged, do not use. Contact your local Medtronic
representative.
Improper connection – Do not connect the Achieve Mapping 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.
Fluoroscopy required for catheter placement – Use of fluoroscopy during catheter

manipulation and placement is strongly advised. Manipulating the catheter without
fluoroscopy may result in damage to cardiac and vascular structures.
X-ray and fluoroscopic exposure – Minimize x-ray and fluoroscopic exposure. Due to the
intensity of the x-ray beam and the duration of the fluoroscopic imaging during catheter
procedures, patients and laboratory staff may be subjected to acute radiation injury and
increased risk for somatic and genetic effects. Take all appropriate measures to minimize
x-ray exposure to both patients and clinical staff. The long-term effects of protracted
fluoroscopy have not been established.
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.
Other catheters, devices, or wires – Avoid catheter entanglement with other catheters,
devices, or wires. Such entanglement may necessitate surgical intervention.

4 mm
15 mm

6 mm
20 mm

Achieve Technical Manual English 3