Device; Sheath Retraction - The Strap Becomes Detached From The Delivery Sheath; Sheath Retraction - The Strap Handle Breaks In Two - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

5.3 SHEATH RETRACTION - THE STRAP BECOMES DETACHED FROM THE DELIVERY SHEATH

Potential Cause
Excessively high deployment forces or poor strap
to sheath attachment strength may result in the
detachment of the strap from the sheath.
Recommended Actions
1. Attach one pair of atraumatic artery forceps to
each side of the sheath.
2. Ensure the handle is stabilised.
3. With the handle stabilised, pull the forceps to
retract both parts of the sheath simultaneously.
Note: Both parts of the sheath must be pulled
back simultaneously to ensure the correct
unsheathing of the stented section of the

device.

5.4 SHEATH RETRACTION - THE STRAP HANDLE BREAKS IN TWO

Potential Cause
An excessive deployment force can contribute
to the potential fracture and/or weakening of
the strap. This may cause it to break during the
device deployment.
Recommended Actions
1. Gather both halves of the strap in one hand.
2. Stabilise the handle of the delivery system.
3. Retract both halves of strap together thus
splitting the sheath in two.
Note: This process could be completed using
atraumatic artery forceps as described in
section 5.3 Sheath Retraction - The strap
becomes detached from the delivery sheath.
19