Product Description; How Supplied - LeMaitre 2107-80 Instrucciones De Uso

LeMaitre® Aortic Occlusion Catheter
(Model Numbers 2107-80, 2107-81, e2107-80, e2107-81)
English – Instructions for Use

Product Description

The LeMaitre® Aortic Occlusion Catheter is offered in two balloon sizes; 28 mm or 45mm. It
is a single lumen catheter with a latex balloon specifically designed and sized for use in the
outlined general procedures. The single lumen (inflation lumen indicated by the white stop-
cock) is used for balloon inflation. Other features include a balloon wall thickness designed to
reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon
inflation level throughout the procedure.

How Supplied

The LeMaitre Aortic Occlusion Catheter is supplied sterile. This device is packaged in a sterile
tray. The sterility of the package is assured as long as it is unopened and undamaged.
Indication
The LeMaitre Aortic Occlusion Catheter is indicated for temporary vessel occlusion.
Specifications Charts
Model
Number
2107-80,
e2107-80
2107-81,
e2107-81
Model
Number
2107-80,
e2107-80
2107-81,
e2107-81
*When inflated to Maximum Inflation Volume.
Contraindications
1. The catheter is not to be used as a dilation catheter.
2. The catheter is not to be used for endarterectomy procedures.
3. The catheter is a temporary device and cannot be implanted.
Warnings
1. Do not reuse. The catheter is for single use only.
2. Air or gas should not be used to inflate the balloon during patient use.
3. Do not inflate the balloon to any greater volume than is necessary to obstruct the blood
flow. DO NOT EXCEED the recommended maximum balloon inflation capacity (see
specifications chart).
4. Exercise caution when encountering extremely diseased vessels. Arterial rupture or
balloon failure due to sharp calcified plaque may occur.
5. Care should be taken when the occlusion causes a high pressure situation, such as in
the ascending aorta, which may damage the balloon or cause difficulties to achieve and
maintain vessel occlusion.
Catheter French Size
8F
8F
Maximum
Maximum
French Size
Inflation
of Deflated
Volume
Balloon
14F 15mL
22F 50mL
LATEX
Usable Length
80cm
80cm
Diameter
of Inflated
Balloon*
28mm
45mm
Average Assisted Deflation
Time*
300 mgI/mL
Saline
Contrast
Solution
Solution
4 sec. 8 sec.
15 sec. 17 sec.