Intended Use; Component Description - Terumo 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 the distal end is
hydrophilically coated. It comes packaged with a dilator and choice
of hemostatic valve types.

INTENDED USE

The Destination Peripheral Guiding Sheath is designed to be used
for the introduction of interventional and diagnostic devices into
the human vasculature, including but not limited to lower extremity
access via a contralateral approach.

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 Peripheral Guiding Sheath has an atraumatic tip
which is hydrophilically coated. Coating length is measured from
the distal end of the sheath.
TABLE 1: Hydrophilic Coating Length
Sheath Length
45 cm & 65 cm
90 cm
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 beyond the tip of the
sheath as captured in Table 2 below.
TABLE 2: Dilator Tip Extension
Sheath Length
45 cm & 65 cm
90 cm
®
Peripheral Guiding Sheath is designed to perform
Fig. 1
5 mm ± 1 mm
Dilator Tip Extension
2.5 cm
5 cm
Coating Length
35 cm
60 cm
3