LeMaitre Pruitt Instrucciones De Uso página 3

12. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
13. This catheter is intended for use in the arterial system. It is not designed for use in
cleaning AV grafts.
14. Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic
Reactions.
Potential Complications
• Infection
• Local Hematomas
• Intimal disruption
• Arterial dissection
• Vessel perforation and rupture
• Hemorrhage
• Arterial thrombosis
• Embolism
• Hypertension or hypotension
• Aneurysms
• Arterial spasms
• Arteriovenous fistula formation
• Balloon rupture
• Tip separation with Fragmentation and Distal Embolization
• Renal insufficiency
• Paraplegia
• Death
Storage/Shelf Life
The shelf life is indicated by the use by date on the package label. Since natural rubber latex
is acted on by environmental conditions, proper storage procedures must be practiced to
achieve optimum shelf life. The product should be stored in a cool dark area away from
fluorescent lights, sunlight and chemical fumes to prevent premature deterioration of the
rubber balloon. Proper stock rotation should be practiced.
Re-sterilization/Repackaging
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and
sterility of the re-processed device cannot be assured. Reuse of the device may lead to cross
contamination, infection, or patient death. The performance characteristics of the device may
be compromised due to reprocessing or re-sterilization since the device was only designed
and tested for single use. The shelf life of the device is based on single use only. If for any
reason this device must be returned to LeMaitre Vascular, place it in its original packaging and
return it to the address listed on the box.
Maximum Liquid
Model
2102-09,
e2102-09
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture of this device.
Except as explicitly provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERM
INCLUDES LEMAITRE VASCULAR, INC., ITS AFFILIATES, AND THEIR RESPECTIVE EMPLOYEES, OFFICERS,
DIRECTORS, MANAGERS, AND AGENTS) MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT
TO THIS DEVICE, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE (INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE)
AND HEREBY DISCLAIMS THE SAME. LeMaitre Vascular makes no representation regarding the suitability
for any particular treatment in which this device is used, which determination is the sole responsibility
of the purchaser. This limited warranty does not apply to the extent of any abuse or misuse of, or failure
to properly store, this device by the purchaser or any third party. The sole remedy for a breach of this
limited warranty shall be replacement of, or refund of the purchase price for, this device (at LeMaitre
Vascular's sole option) following the purchaser's return of the device to LeMaitre Vascular. This war-
ranty shall terminate on the expiration date for this device.
IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, SPE-
CIAL, PUNITIVE, OR EXEMPLARY DAMAGES. IN NO EVENT WILL THE AGGREGATE LIABILITY OF LEMAITRE
Capacity
4.0 mL
Specifications
Maximum Gas
Capacity
5.0 mL
Contents
One Catheter, One Syringe,
5.0 mL