Abbott AMPLATZER Sizing Balloon II Series User Manual

1
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833
ARTEN600038218A
2018-08
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2018 Abbott. All Rights Reserved.
Device Description
The AMPLATZER™ Sizing Balloon II is a triple lumen balloon catheter with three (3) radiopaque marker bands located inside
the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4 mm apart
(inside to inside), and one (1) marker band 15 mm proximal of that pair (15 mm from the proximal edge of the pair of marker
bands) (figure 1).
Intended Use
The AMPLATZER™ Sizing Balloon II is designed to measure cardiovascular structures. Sizing can be accomplished in two
ways: radiographically or echocardiographically.
Indications for Use
The AMPLATZER™ Sizing Balloon II is indicated for use in those patients with cardiovascular defects wherein accurate
measurement of the defect is important in selecting the appropriately sized occluder device.
Precautions and Warnings
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to
resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
• Do not use this device if the sterile package is open or damaged.
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• Do not insert the balloon catheter through an introducer sheath.
Figure 1. AMPLATZER™ Sizing Balloon II
Sizing Balloon II
Instructions for Use

Abbott AMPLATZER Sizing Balloon II Series Specifications

General

Product Name	AMPLATZER Sizing Balloon II Series
Product Type	Sizing Balloon Catheter
Manufacturer	Abbott
Category	Medical Equipment
Balloon Compliance	Non-compliant
Catheter Length	100 cm
Usable Catheter Length	90 cm
Guidewire Compatibility	0.035 inch
Sterility	Sterile
Radiopacity	Radiopaque marker bands
Available Sizes	40 mm
Packaging	Individually packaged in sterile pouch
Catheter Compatibility	Compatible with standard catheters
Intended Use	The AMPLATZER Sizing Balloon II is intended to measure the size of atrial septal defects (ASD) or patent foramen ovale (PFO) during transcatheter closure procedures.

Summary

Device Description

Intended Use

Indications for Use

Precautions and Warnings

Adverse Events

Directions for Use

Recommendations on Guidewire and Balloon Use

Guidance on using the guidewire and balloon inflation volume to prevent kinking, migration, over-inflation, bursting, or detachment.

Procedure

Step-by-step instructions for inspecting, preparing, and using the balloon catheter for measurement, including specific steps for septal defects.

Disposal

Warranty

Symbol Definitions