English - Radi FemoSeal 11202 Manual

ENGLISH

Device description
FemoSeal vascular Closure System is a medical device indicated for closure
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of an arterial puncture after percutaneous catheterization through the femoral
artery. FemoSeal
the Inner Seal and Outer Locking Disc, which are held together by a resorb­
able multifilament, thereby mechanically sealing the arteriotomy. Hemostasis is
achieved by mechanical means.
Sheath
Indication for use
FemoSeal vascular Closure System is indicated for use in closing the femoral
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arterial puncture (arteriotomy) in patients who have undergone percutaneous
catheterization using a 7F (2.33 mm) or smaller procedural sheath.
Contraindications
FemoSeal vascular Closure System is contraindicated in patients with arterio­
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tomies in which sheaths or devices larger than 7F (2.33 mm) have been used.
Warnings
· Do not use if the package has been damaged or any sterile barrier is not
intact.
· Do not use after expiry date ­ the biodegradable components may not perform
adequately.
· Do not use if any items appear damaged or defective in any way.
· Use of FemoSeal
of the procedural sheath or the surrounding tissue may have occurred, may
cause infection.
· If it is suspected that the posterior arterial wall has been punctured or more
than one arterial puncture has been made, do not rely solely on FemoSeal
vascular Closure System to achieve arterial hemostasis. Use additional
manual or mechanical compression.
· If the puncture site is at, or distal to the bifurcation of the femoral artery,
Closure Elements consist of two resorbable polymer discs,
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Guidewire 0.038" (0.97 mm)
vascular Closure System where bacterial contamination
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Dilator
3
FemoSeal Unit
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