LeMaitre Pruitt Mode D'emploi page 3

• Tip separation with Fragmentation and Distal Embolization
• Renal insufficiency
• Paraplegia
• Death
Model
Maximum Liquid Capacity
Usable Length
Contents
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.
Safe Handling and Disposal
This device is single-use and disposable device. Do not implant. Please return the used device only
at the time that the device has not performed as intended or the device is related to an adverse
event. In other situations, the device should not be returned but disposed accorded to local
regulations.
If serious medical incidents should arise during use of this medical device, users should notify both
LeMaitre Vascular and the Competent Authority of the country where the user is located.
This product contains no sharps, heavy metals or radioisotopes, and is not infectious or pathogenic.
No special requirements for disposal are evident. Please consult local regulations to verify proper
disposal.
Cleaning:
1. Devices considered necessary to return should be cleaned using one of the following:
a) Sodium hypochlorite solution (500-600 mg/l), or
b) Peracetic acid solution with subsequent ultrasonic treatment
2. Devices should then be decontaminated with either:
a) 70% solutions of ethanol or isopropanol for a minimum of 3 hours or,
b) Ethylene oxide gas
3. Devices should be completely dried prior to packaging.
Packaging:
1. Cleaned devices should be sealed and packed in a manner that minimizes potential for breakage,
contamination of the environment or exposure to those handling such packages during transit. For
devices capable of penetrating or cutting skin or packaging material, the primary packaging must
be capable of maintaining the product without puncture of the packaging under normal conditions
of transport.
2. The sealed primary container should be placed inside watertight secondary packaging. The second-
ary packaging should be labelled with an itemized list of the contents of the primary receptacle.
Cleaning methods should be detailed if possible.
3. Both primary and secondary packaging of cleaned, decontaminated single-use disposable devices
should be labelled with an ISO 7000-0659 Biohazard symbol.
4. Primary and secondary packaging must then be packaged inside an outer package, which must be
a rigid, fiberboard box. The outer shipping container must be provided with sufficient cushioning
material to prevent movement between the secondary and outer containers.
5. Shipping paper and content marking for the outer shipping container are not required.
6. Packages prepared in the above manner may be shipped to:
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc., warrants that reasonable care has been used in the manufacture of this device and that
this device is suitable for the indication(s) expressly specified in these instructions for use. Except as explicitly
Specifications
2103-36 2103-46
0.5 mL 0.5 mL
27 cm
One Catheter, One Syringe, 3 mL
LeMaitre Vascular
Attn: Complaint Lab
63 Second Avenue
Burlington, MA 01803
3
2103-56
1.0 mL