Amplatzer Vascular Plug Instructions For Use - Amplatzer ML 25 Instrucciones De Uso

AMPLATZER ® Vascular Plug
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician (or
properly licensed practitioner).
Device Description
The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire
mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro
screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long
pusher wire (Fig. 1). The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to
16mm in 2 millimeter increments. (Fig. 2)
Intended Use
The AMPLATZER Vascular Plug is indicated for arterial and venous embolizations in the peripheral
vasculature.
Contraindications
None Known
Warnings
The safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus
or paravalvular leak closures) and neurological uses have not been established.
Potential Adverse Events
Potential complications include, but are not limited to: hematoma at the site of entry, vessel
perforation, or embolization of the device.
Precautions
Handling
• Patients allergic to nickel may suffer an allergic reaction to this device.
• The AMPLATZER Vascular Plug is for single use only. Do not reuse or resterilize.
• Use before the Expiration Date noted on the packaging.
• Do not use open or damaged packages.
• Store in a cool, dry place.
• Do not use if the sterile barrier is compromised in any way.
How Supplied
The AMPLATZER Vascular Plug is sterile and preloaded in a loader, and is attached to a 135 cm
long pusher wire that is placed within a hoop dispenser (Fig. 3). Refer to Table 1 for recommended
catheter size.
Table 1:
Order No. AMPLATZER Device
Vascular Plug Length
Diameter
9-PLUG-004 4 mm
9-PLUG-006 6 mm
9-PLUG-008 8 mm
9-PLUG-010 10 mm
9-PLUG-012 12 mm
9-PLUG-014 14 mm
9-PLUG-016 16 mm
* For use with standard guiding catheters meeting minimum internal diameter requirements.
C A T H E T E R
Minimum
Size
7 mm 5 French
7 mm 5 French
7 mm 5 French
7 mm 6 French
8 mm 6 French
8 mm 8 French
8 mm 8 French
R E Q U I R E M E N T S *
Minimum
ID
0.056"
0.056"
0.056"
0.067"
0.067"
0.088"
0.088"
1
Maximum
Length
100cm
100cm
100cm
100cm
100cm
100cm
100cm