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Sizing Balloon II
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).
Figure 1. AMPLATZER™ Sizing Balloon II
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.
™ 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.
Instructions for Use
1
ARTEN600038218A
2018-08
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833
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Related Manuals for Abbott AMPLATZER Sizing Balloon II Series
Summary of Contents for Abbott AMPLATZER Sizing Balloon II Series
- Page 1 • Do not insert the balloon catheter through an introducer sheath. ARTEN600038218A 2018-08 ™ Indicates a trademark of the Abbott group of companies. Manufacturing facility: ‡ Indicates a third party trademark, which is property of its respective owner. Abbott Medical Pat.
- Page 2 • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device. • Store in a dry place. Adverse Events Potential adverse events that may occur during or after a procedure using this delivery system may include, but are not limited •...
- Page 3 1. Inflate the balloon with saline solution and purge the air in a position as shown in figure 1 or inflate with CO2 and aspirate. Flush the other lumen with heparinized saline. 2. Manipulate a 0.035 inch stiff exchange wire into the left upper lobe pulmonary vein. Introduce the balloon catheter over the guidewire.
- Page 4 Warranty Abbott Medical warrants to buyer that, for a period equal to the validated shelf life of the product, this product shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer's instructions for use and shall be free from defects in materials and workmanship.
- Page 5 Symbol Definitions The following symbols may appear on the device packaging: Symbol Definition Caution, consult accompanying documents Manufacturer EU authorized representative Reference number Product serial number Batch Code Use by date (Use on or before the last day of the expiration month noted on the product packaging.) Do not reuse Sterilized using ethylene oxide Unique device identification...
- Page 6 Hydrophilic coating Recommended delivery sheath/catheter dimensions Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Contains phthalate Quantity Date of manufacture Sizing Balloon...