Tabla De Contenido - Amplatzer Vascular Plug II Instrucciones De Uso

AMPLATZER ® Vascular Plug II
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Section
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Potential Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Directions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Device Description
The AMPLATZER Vascular Plug II is a self-expandable nitinol mesh occlusion device
(see Figure 1).
A
B
C
Figure 1. AMPLATZER Vascular Plug II
The device has a screw attachment for a delivery wire and radiopaque marker bands at both ends. The
AMPLATZER Vascular Plug II is attached to a 135-cm delivery wire with a stainless steel screw. The
AMPLATZER Vascular Plug II is packaged within a loader, pre-connected to the delivery wire in a hoop
dispenser. A plastic vise is included with each device (Figure 2).
B
E
Figure 2. AMPLATZER Vascular Plug II Preloaded Device
Plugs are available in the sizes referenced in Table 1.
A. Nitinol mesh
B. Screw attachment
C. Marker Bands
C
A
D
C
1
A. Hoop Dispenser
B. Delivery Wire
C. Loader
D. Preloaded Device
E. Plastic Vise
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