Radi FemoSeal 11202 Manual page 4

FemoSeal vascular Closure System should not be used due to the risk of
®
the Inner Seal being positioned incorrectly. This event may result in bleeding
complications and/or disruption to normal blood flow.
· If there is persistent arterial bleeding from the incision site, do not cut the
multifilament until hemostasis is achieved. If hemostasis is not achieved, fas­
ten the multifilament with a sterile wound dressing and apply supplementary
compression until hemostasis is achieved. In the case of persistent arterial
bleeding, significant bleeding complications may occur which could result in
patient injury or death.
Special patient populations
The safety and effectiveness of FemoSeal
been established in the following patient populations:
· Patients with pre­existing autoimmune disease.
· Patients undergoing therapeutic thrombolysis.
· Patients with clinically significant peripheral vascular disease.
· Patients with uncontrolled hypertension (> 220 mmHg systolic or > 110 mmHg
diastolic).
· Patients with a bleeding disorder, including thrombocytopenia (< 100,000
platelet count), or anemia (Hgb < 10 mg/dl).
· Patients having an inner lumen of the common femoral artery smaller than 5 mm.
· Patients with a vascular graft or stent at the puncture site.
· Patients who are pregnant or lactating.
· Patients below the age of 18 years.
Precautions
· FemoSeal vascular Closure System deployment procedure should be per­
®
formed by physicians with adequate training in the use of the device.
· Perform a limited femoral angiogram prior to FemoSeal
System deployment.
· 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.
· If any hematoma is present, extra care must be taken for correct insertion of
the sheath into the artery.
· Use a single wall puncture technique. Do not puncture the posterior wall of
the artery.
· Observe sterile technique at all times when using FemoSeal
sure System.
· FemoSeal vascular Closure System is for single use only and should not be
®
vascular Closure System has not
®
4
vascular Closure
®
vascular Clo­
®