1. Remove Fibrex® device assembly from packaging
tray. Withdraw Fibrex® coil into catheter system
by
rotating thumb wheel counter-clockwise one
complete
revolution. Ensure Fibrex® coil marker snugly
opposes guidecurve opening. Caution: Do not over-rotate
thumb
wheel; note “start-stop” markings on the thumb
wheel.
2. Retract guidecurve into catheter assembly by
completely retracting the guidecurve lever
located on
the hand-piece assembly. Note: Ensure Fibrex®
coil
marker band snugly opposes outer-catheter
opening.
3.
Adequately lubricate hydrophilic outer
catheter with
saline solution.
Deployment Instructions:
Caution: Prior to initiating the
procedure
compare lumen
length and internal diameter of
the malfunctioning vascular
access catheter to the Fibrex®
device specifications to ensure
compatibility.
4. Insert the Fibrex® catheter tip into the
venous lumen
of the vascular access catheter to be cleared.
5. Tightly secure the Fibrex® hemostasis valve’s
luer
lock to the venous lumen connector of the
catheter.
6. Slowly feed the Fibrex® catheter through the
entire
length of the venous lumen until the Fibrex®
catheter
tip marker band can be clearly visualized
exiting the distal
end of the vascular access catheter via
fluoroscopic
guidance.
Caution: Ensure the Fibrex® distal
catheter
tip protrudes 1-3mm through the most distal exit
hole
of the vascular access catheter.
7. Once Fibrex® catheter tip is properly
positioned,
tightly secure the hemostasis valve to the
Fibrex®
proximal catheter shaft to prevent movement of
catheter assembly.
8. Actuate the guidecurve by advancing the
guidecurve
lever to the forward position. Ensure the lever
is extended
completely forward. Visually confirm that the
Fibrex® coil
distal tip radiopaque marker has been caudally
redirected.
9. Advance the Fibrex® coil around the vascular
access
catheter by advancing the thumb wheel in a
clockwise
direction. Advance the thumb wheel one complete
revolution. Caution: Note the “start-stop”
markings on
the thumb wheel so as not to over-rotate.
10. Once Fibrex ® coil has been completely
deployed,
slowly rotate the entire Fibrex® hand-piece in a
clockwise direction. Slowly rotate or spin the
hand-piece
10-15 revolutions or until fibrin has been
visibly removed.
11.
Following fibrin sheath removal, catheter patency
can be confirmed (with Fibrex® remaining within
the
vascular access catheter) via a 10cc injection
of
contrast solution through the injection arm of
the
Fibrex® hemostasis device, and observing outcome
flow patterns via fluoroscopy. If flows patterns
are
not acceptable, repeat step #7.
12. Withdraw Fibrex® coil into catheter system
by rotating
thumb wheel counter clockwise one complete
revolution.
Ensure Fibrex® coil marker snugly opposes
guidecurve
opening. Caution: Note the “start-stop” markings
on the
thumb wheel so as not to over-rotate.
13. Retract Guidecurve into catheter assembly by
completely retracting the guidecurve lever
towards the
proximal end of the hand-piece assembly. Note:
Ensure Fibrex® coil radiopaque marker snugly
opposes outer-catheter opening.
15. Catheter patency should once again be
confirmed
via a 10cc injection of contrast solution
through the
venous and arterial lumens, observing outcome
flow
patterns via fluoroscopy.
Adequately lubricate hydrophilic outer
catheter with
saline solution.
