Adverse Events - LeMaitre 2107-80 Instrucciones De Uso

6. Deflate the balloon prior to inserting or withdrawing the catheter. Avoid using excessive
force to push or pull catheter against resistance.
7. The possibility of balloon rupture or failure must be taken into account when considering
the risk involved in a balloon catheterization procedure.
Precautions
1. Inspect the product and package prior to use and do not use the catheter if there is any
evidence that the package or the catheter has been damaged.
2. Avoid extended or excessive exposure to fluorescent light, heat, sunlight, or chemical
fumes to reduce balloon degradation. Excessive handling during insertion, or plaque and
other deposits within the blood vessel may damage the balloon and can increase the
possibility of balloon rupture.
3. Ensure proper connections between all syringes and hubs to avoid the introduction of air.
4. Do not grasp the balloon with instruments at any time to avoid damage to the latex.
5. Do not expose to organic solvents (e.g, alcohol).
6. Excessive calcification of the site of reconstruction may impair performance.
7. Use of highly viscous or particulate contrast medium is not recommended for balloon
inflation because the inflation lumen may become occluded.

Adverse Events

As with all catheterization and surgical procedures, complications may occur. These may
include, but are not limited to:
• infection
• local hematomas
• intimal disruption
• arterial dissection
• vessel perforation and rupture
• hemorrhage
• arterial thrombosis
• distal emboli of blood clots or arteriosclerotic plaque
• air embolus
• aneurysms
• arterial spasm
• arteriovenous fistula formation
• balloon rupture
• tip separation with fragmentation and distal embolization
• renal insufficiency
• paraplegia
Instructions for Use
Pre-Use Instructions
1. Aspirate the balloon completely prior to inflation of the balloon with sterile
saline to its recommended balloon inflation volume (see specifications chart).
2. Inflate the balloon with sterile saline and inspect for leaks. If there is any
evidence of leaks around the balloon or if the balloon will not remain inflated,
do not use the product.
3. Check the balloon by inflating and deflating with sterile saline for injection
before use. If the balloon does not appear to function normally, do not use the
product.
4. Obtain the smallest syringe that will hold the balloon's stated maximum liquid
capacity. Fill the syringe to the volume indicated with a sterile, blood compatible
medium. Fluid may include a highly diluted, nonparticulate, radiopaque
solution. Connect the syringe to the stop-cock.
Catheter Placement
1. Place the catheter into the desired position through an arteriotomy or venotomy.
Balloon Inflatlon
1. Ensure that the stop-cock is in the open position. Slowly inject the inflation
medium until occlusion is obtained. Close the stop-cock to maintain occlusion.
Fluoroscopic visualization is recommended where appropriate to ensure proper