Potential Adverse Events; How Supplied; Symbol Definitions - AGA Medical AMPLATZER Mode D'emploi

6. Potential Adverse Events

• Air embolus
• Allergic dye reaction
• Allergic drug reaction
• Anesthesia reactions
• Apnea
• Arrhythmia
• Arterial pulse loss
• Bacterial endocarditis
• Bleeding
• Brachial plexus injury
• Cardiac arrest
• Chest pain
• Compromised hemodynamics
• Critical limb ischemia
• Critical limb loss
• Death
• Device embolization
• Fever
• Headache

7. How Supplied

The AMPLATZER Duct Occluder II is packaged separately from the AMPLATZER TorqVue LP Delivery System. Refer to
Table 2 for the recommended delivery catheter sizes.

8. Symbol Definitions

In addition to the harmonized symbols defined in ISO 15223, the following symbols may appear on the
device packaging:
8. Directions for Use
1. Perform a right heart catheterization. Size the diameter and length of the patent ductus arteriosus using
angiography. See figure 2 for sizing locations.
2. Select appropriate occluder according to table 1.
• Hemolysis
• Hypertension
• Hypotension
• Infection
• Loss of peripheral pulse
• Migraine
• Myocardial infarction
• Partial obstruction of pulmonary artery
• Partial obstruction of aorta
• Peripheral embolism
• Seizure
• Stroke
• Thrombus
• Transient ischemic attack (TIA)
• Valvular regurgitation
• Vascular access site complications
• Vascular damage
• Vascular irritation
Length of device
Outer diameter of device
Device is latex-free
Number of devices in package
4