Le Maitre 1009-00 Mode D'emploi page 3

7. Do not rotate the Green Handle while the LeMaitre Valvulotome device is in open position.
Potential Complications
• Vessel wall perforation
• Intimal disruption
• Residual tributaries
• Entrapment of cutting blades in branches or
anastomoses
• Inadequate valve disruption
• Vein Stricture
• Thrombus formation
• Post-procedure wound necrosis
Additional Required Items
1. Radiopaque Tape
2. 3cc Syringe
Specifications
LeMaitre Valvulotome:
White Handle
Irrigation Port
LeMills Valvulotome:
Handle
Useable
Catalog Number
Length
1009-00, e1009-00 98 cm
1009-00J 98 cm
1010-00, e1010-00 40 cm
1011-00, e1011-00 98 cm
1012-00, e1012-00 40 cm
To Open Package
1. Open box and remove sealed sterile unit.
2. Open sealed sterile unit and present contents to personnel in sterile environment.
3. Carefully remove lids, as applicable.
Caution: Remove product from tray with care to ensure centering hoops are not damaged.
4. Place in basin filled with sterile, heparinized saline.
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Body
Closed Maximum Open
Catheter Outer Cutting Blade
Diameter Diameter
1.5 mm 6.0 mm
1.5 mm 6.0 mm
1.5 mm 6.0 mm
1.5 mm 6.0 mm
1.5 mm 6.0 mm
Vessel damage
Vessel Occlusion/ Stenosis
Hematoma
Hemorrhage
Infections
Erythema
Entrapment of cutting heads/ blades
Embolism
Centering Hoops
Cutting Blades
Protective Sheath
Blade
Maximum Open
Centering Hoop
Diameter
9.5 mm
9.5 mm
9.5 mm
9.5 mm
9.5 mm
Bullet Head
LeMills
Valvulotome
Included
Not Included
Not Included
Included
Not Included