NuMED MULLINS-X Instrucciones De Utilizacion página 3

• Complications associated with PTA include, but are not limited to : clot formation and embolism, nerve
damage, vascular perforation requiring surgical repair, damage to the vascular intima, cerebral accident,
cardiac arrhythmias, myocardial infarction, or death. For specifics, refer to: Fellows, K. et al.: Acute
Complications of Catheter therapy for Congenital Heart Disease, Amer Journ of Cardiol, 60;679(1987).
NOTE: There have been infrequent reports of larger diameter balloons bursting circumferentially, possibly due to
a combination of tight focal strictures in large vessels. In any instance of a balloon rupture while in use, it is
recommended that a sheath be placed over the ruptured balloon prior to withdrawal through the entry site. This
can be accomplished by cutting off the proximal end of the catheter and slipping an appropriately sized sheath
over the catheter into the entry site. For specific technique, refer to: Tegtmeyer, Charles J., M.D. & Bezirdijan
Diran R., M.D. "Removing the Stuck, Ruptured Angioplasty Balloon Catheter." Radiology, Volume 139, 231-232,
April 1981.
INSPECTION AND PREPARATION
1. Insert guidewire through the distal tip until guidewire exceeds proximal port.
2. Remove balloon protector. Inspect the catheter for damage prior to insertion.
3. Perform dilatations using either a 50/50 or a 75/25 solution of saline and contrast medium, respectively.
4. Attach an inflation device with pressure gauge half filled with the contrast solution to the balloon port of the
catheter.
5. Purge the catheter through lumen thoroughly, observing for leaks.
6. To check inflation/deflation times, use a stopwatch. Repeat the procedure several times to verify the inflation /
deflation time.
7. Point inflation device with pressure gauge nozzle downward, aspirate until all air is removed from the balloon,
and bubbles no longer appear in the contrast solution.
8. Turn the stopcock off to maintain the vacuum in the balloon.
9. Remove guidewire.
INSERTION: VASCULAR
1. Enter the vessel percutaneously using the standard Seldinger technique over the appropriate guidewire for the
size catheter being used.
2. Advance the catheter across the lesion with fluoroscopic guidance using accepted percutaneous transluminal
angioplasty technique (see references). In most patients, the balloon should meet with minimal resistance to
insertion. Do not advance the catheter unless the guidewire is in place.
3. Referring to the balloon-sizing chart, inflate the balloon with contrast medium until the desired diameter is
achieved or the RBP is reached, whichever comes first. DO NOT EXCEED THE RBP.
DEFLATION AND WITHDRAWAL
1. Deflate the balloon by drawing a vacuum with an inflation device with pressure gauge. Note: The greater the
vacuum applied and held during withdrawal, the lower the deflated balloon profile.
2. Gently withdraw the catheter. As the balloon exits the vessel, use a smooth, gentle, steady motion. If
resistance is felt upon removal, then the balloon, guidewire, and the sheath should be removed together as a
unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected. This may
be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together,
using a gentle twisting motion combined with traction.
3. Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous
vascular procedures.
INDICATIONS: Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
• A patient with isolated pulmonary stenosis.
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require
surgical intervention
CONTRAINDICATIONS
Other than standard risks associated with insertion of a cardiovascular catheter, there are no known
contraindications for valvuloplasty. The patient's medical condition could affect successful use of this catheter.
• Patients with mild valvular stenosis.
• A patient with valvular stenosis with major congenital heart defects that requires open heart surgery.
WARNINGS
• CAUTION: Do not exceed the RBP. An inflation device with pressure gauge is recommended to monitor
pressure. Pressure in excess of the RBP can cause balloon rupture and potential inability to withdraw the
catheter through the introducer sheath.
• Catheter balloon inflation diameter must be carefully considered in selecting a particular size for any patient.
The inflated balloon diameter should not be significantly greater than valvular diameter. The choice of the
balloon size to be used for valve stenosis has been established by the VACA Registry to be approximately
1.2 to 1.4 times the valve annulus. It is important to perform an angiogram prior to valvuloplasty to measure
the size of the valve in the lateral projection.
• Balloons > 4cm in length may impinge upon the tricuspid valve mechanism and may injure it. Balloons longer
than 4cm are not recommended for children  10 years old.
Instructions for Use (PTV)
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