Radi FemoSeal 11202 Manual page 5

resterilized or reused in any manner.
· If deployment of the Inner Seal meets unexpected resistance, discontinue the
procedure.
· For correct deployment of Inner Seal, reposition your thumb so that the button
can spring back freely.
· Ensure the tip of the sheath of FemoSeal
before deployment of the Outer Locking Disc. The Outer Locking Disc may
inadver tently be deployed above skin level in patients with a short distance
between the femoral artery and the skin level.
· For correct deployment, a skin incision may be necessary before deployment.
· If the Inner Seal is inside the artery, but it is not possible to fully depress the
button and deploy the Outer Locking Disc, surgery may be required to remove
FemoSeal Closure Elements.
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· If repuncture of the same femoral artery becomes necessary within 90 days,
repuncture should be made at least one centimeter proximal to the previous
FemoSeal vascular Closure System access site.
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· Instruct the patient to follow physician's orders regarding closure site inspec­
tion.
· Instruct the patient to carry the Patient Information Card for the next 90 days.
Precautions at time of discharge
Before considering discharge, assess the patient for the following clinical con­
ditions:
· Bleeding and/or hematoma at the closure site.
· Pain while walking.
· Signs of infection at the closure site.
adverse events
adverse events that may occur and suggested treatment:
· Bleeding and hematoma – Pressure may be applied to the puncture site
using digital or manual pressure, or using a compression device such as
FemoStop Femoral Compression System (Radi Medical Systems) to provide
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supplementary compression.
· AV fistula or pseudoaneurysm – If suspected, the condition may be evaluated
with duplex ultrasound. When indicated, ultrasound guided compression of
a pseudoaneurysm, e.g. FemoStop
Medical Systems), may be used. For severe bleeding complications, other
therapeutic treatment may be appropriate.
· FemoSeal Closure Element non-deployment – If FemoSeal
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Elements pull out with FemoSeal
mechanical pressure per standard procedure. Examine the device to ensure
all resorbable components have been withdrawn.
· Ischemic symptoms, arterial obstruction – Should ischemic symptoms ap­
pear, consider ultrasound examination to locate position of Inner Seal since
Unit is under the skin surface
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Femoral Compression System (Radi
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Unit upon withdrawal, apply manual or
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Closure
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