Radi FemoSeal 11202 Manual page 6

vascular surgery may be indicated. Consider thrombolytic treatment. Monitor
the patient for at least 24 hours.
· Infection – any sign of infection at the puncture site should be taken seriously
and the patient monitored carefully. Consider antibiotic treatment.
· Edema ­ Resorption of the implanted components is associated with a slight
foreign body reaction. On rare occasions this can lead to a local edema.
FemoSeal vascular Closure System insertion procedure
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The procedure is described in the following steps:
1. Assess puncture site location by fluoroscopy.
Perform a limited femoral angiogram prior to FemoSeal
System deployment.
Caution: Discontinue procedure if:
· Lumen diameter of common femoral artery < 5 mm.
· Stenosis and/or significant plaque present in the vicinity of the femoral
arterial puncture site.
· arterial puncture is at, or distal to, the common femoral artery bifurcation.
· anomalous branches or vessel abnormalities present in the vicinity of the
femoral arterial puncture site.
Caution: If any hematoma is present, extra care must be taken for correct
insertion of the sheath into the artery.
2. Position the sheath of FemoSeal
a) Insert FemoSeal
and marked signs meet (see figures 1a, 1b).
notE: Grip FemoSeal
b) Insert the guidewire through the procedural sheath.
c) Remove the procedural sheath and hold the guidewire in position (see
figure 2).
d) Thread FemoSeal
artery (see figures 3a, 3b).
notE: Leave approximately 25 cm of the guidewire visible.
3. Grip and squeeze the wings of FemoSeal
FemoSeal Safety Catch slowly along with the guidewire until com-
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pletely removed (see figures 4a, 4b, 4c, and 4d).
notE: Hold the device in position with the opposite hand. When FemoSeal
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Dilator into FemoSeal
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Dilator near its tip, advance carefully in small increments.
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Unit over the guidewire and insert the sheath into the
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Unit inside the artery.
Unit until they snap together
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Safety Catch, lift and retract
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vascular Closure
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