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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®Unit is under the skin surface
before deployment of the Outer Locking Disc. The Outer Locking Disc may
inadvertently 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.
· 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.
· 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
supplementary compression.
· AV stula or pseudoaneurysm – If suspected, the condition may be evaluated
with duplex ultrasound. When indicated, ultrasound guided compression of
a pseudoaneurysm, e.g. FemoStop®Femoral Compression System (Radi
Medical Systems), may be used. For severe bleeding complications, other
therapeutic treatment may be appropriate.
· FemoSeal® Closure Element non-deployment – If FemoSeal®Closure
Elements pull out with FemoSeal®Unit upon withdrawal, apply manual or
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all resorbable components have been withdrawn.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
