Intended Use; Component Description - Terumo Pinnacle Destination Mode D'emploi

DESCRIPTION
The Destination
as a guiding catheter and an introducer sheath. The sheath is coil
reinforced, has a radiopaque marker and approximately 15 cm
(150 mm) of the distal tip is hydrophilically coated. It comes
packaged with a dilator and choice of hemostatic valve types.

INTENDED USE

The Destination Carotid Guiding Sheath is designed to be used for
the introduction of interventional and diagnostic devices into the
human vasculature, including but not limited to the carotid arteries.

COMPONENT DESCRIPTION

Refer to product labeling for appropriate system components.
All components that enter blood vessels are radiopaque.
The contents of this package may differ from that shown in the
figure above.
Sheath
This highly flexible, reinforced sheath is designed to resist kinking.
It incorporates a radiopaque marker located approximately 5 mm
proximal to the tip (Fig. 1). The Destination Carotid Guiding Sheath
is available in multiple distal segments shapes. The sheath has an
atraumatic tip which is hydrophilically coated. Coating length is
approximately 15 cm (150 mm) as measured from the distal end.
Dilator
The precise fit of the dilator in the sheath allows for simultaneous
motion of both dilator and sheath. The radiopacity of the dilator has
been greatly enhanced to increase the visibility. The distal segment
of the dilator has been optimized to extend approximately 5 cm
(50 mm) beyond the tip of the sheath.
Valve
Each Destination Carotid Guiding Sheath comes packaged with
either a Cross Cut Valve assembly (CCV) or a Y-shaped Tuohy-
Borst Valve (TBV). Both valve types are equipped with a three way
stopcock connected by a side tube.
®
Carotid Guiding Sheath is designed to perform
Fig. 1
5 mm ± 1 mm
Cross Cut Valve Assembly (CCV)
Y-Shaped Tuohy-Borst Valve (TBV)
3