Amplatzer Sizing Balloon; Instructions For Use - AGA AMPLATZER Gebrauchsanweisung

AMPLATZER ® Sizing Balloon II

Instructions For Use

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
Federal (USA) law restricts this device to sale by or on the order of a physician.
• This device is intended for one time use only.
• Do not re-sterilize.
• Store in a dry place.
• Do not use if the packaging has been opened or damaged.
• Use the catheter before the Expiration Date noted on the package.
• Do not use if the sterile barrier is compromised in any way.
• Do not insert the balloon catheter through an introducer sheath.
• This device should only be used by those physicians trained in transcatheter defect
sizing techniques.
Potential Complications
The complications that may result from a balloon procedure include:
• Vessel perforation
• Thromboembolic event
• Sepsis/Infection
• Vessel spasm
• Hematoma
Potential complications specific to balloon sizing include:
• Movement of the balloon toward the mitral valve or right atrium
• Enlargement of the ASD
• Obstruction of venous return from the inferior vena cava
• Difficulty in deflating the balloon
Recommendations on Guidewire and Balloon Use
The guidewire must remain in place during the procedure. The removal of the guidewire during
the procedure can cause kinking and/or migration of the sizing catheter. The maximum inflation
volume of the balloon should not be exceeded to prevent over-inflation, bursting or detachment
of the balloon.
• Embolization
• Vessel dissection
• Pain and tenderness
• Endocarditis
• Vascular thrombosis
• Arrythmias
• Short-term hemodynamic compromise
• Valve impingement
• Oversizing of the defect
• Cardiac obstruction
1