ENGLISH
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
Device Description
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Balloon Valvuloplasty Catheter is an over-the-wire coaxial
catheter with a balloon fixed at the tip. The catheter is available in 110cm and 55cm
lengths, and has two lumens: one lumen is used to inflate and deflate the balloon
and the other permits the use of a guidewire to position the catheter. The balloon
inflation luer-lock hub (angled) connects to a syringe inflation device to deliver
radiopaque contrast media for inflation. The guidewire luer-lock hub (straight)
connects to the guidewire lumen. The balloon is non-compliant and is designed to
reach a known diameter and length when inflated within the specified pressure range.
Two radiopaque marker bands are provided for fluoroscopic positioning of the device
across the aortic valve. These bands are positioned at the proximal and distal balloon
shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation
pressure, recommended introducer size, and recommended guidewire size are
indicated on the package label.
Indications for Use
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Balloon Valvuloplasty Catheter is indicated for balloon aortic
valvuloplasty.
Contraindications
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Balloon Valvuloplasty Catheter is contraindicated for use in
patients with annular dimensions < 18 mm.
Warnings
1. Contents supplied STERILE using ethylene oxide (EO). Non-pyrogenic. Do
not use if sterile barrier is opened or damaged. Single patient use only. Do
not reuse, reprocess or re-sterilize.
2. This device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body fluids
or tissues with potential pyrogenic or microbial contamination have had
contact with the medical device for an indeterminable amount of time.
The residue of biological material can promote the contamination of the
device with pyrogens or microorganisms which may lead to infectious
complications.
3. Do not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical device
increases the probability that the device will malfunction due to potential
adverse effects on components that are influenced by thermal and/or
mechanical changes.
4. Catheter balloon inflation diameter must be carefully considered in
selecting a particular size for any patient. It is critical to perform a
clinical diagnostic determination of valve anatomical dimensions prior
to use; imaging modalities such as transthoracic echocardiogram (TTE),
computerized tomography (CT), angiography, and/or transesophageal
echocardiogram (TEE) should be considered. The inflated balloon diameter
should not be significantly greater than valvular diameter.
5. When the catheter is exposed to the vascular system, it should be
manipulated while under high-quality fluoroscopic observation. Do
not advance or retract the catheter unless the balloon is fully deflated.
If resistance is met during manipulation, determine the cause of the
resistance before proceeding. Applying excessive force to the catheter can
result in tip breakage or balloon separation, or cause injury to the patient
(such as vessel perforation).
6. If flow through catheter becomes restricted, do not attempt to clear catheter
lumen by infusion. Doing so may cause catheter to rupture, resulting in
vessel trauma. Remove and replace catheter.
7. Do not exceed the RBP recommended for this device. Balloon rupture may
occur if the RBP rating is exceeded. To prevent over-pressurization, use of
a pressure monitoring device is recommended.
8. After use, this product may be a potential biohazard. Handle and dispose of
in accordance with acceptable medical practices and applicable local, state,
and federal laws and regulations.
9. If using device to support Transcatheter Aortic Valve Implantation (TAVI),
consult TAVI system’s Instructions for Use for any additional procedural
instructions related to selection and use of valvuloplasty balloon.
Precautions
1. Carefully inspect the catheter prior to use to verify that catheter has not been
damaged during shipment and that its size, shape and condition are suitable for
the procedure for which it is to be used. Do not use if product damage is evident.
2. The catheter should only be used by physicians trained in the performance of
percutaneous transluminal valvuloplasty.
3. The minimal acceptable French size is printed on the package label. Do not
attempt to pass the catheter through a smaller size sheath introducer than
indicated on the label.
4. Use the recommended balloon inflation medium of 1/3 to 2/3 contrast to saline
ratio. Never use air or other gaseous medium to inflate the balloon.
5. If resistance is felt during post procedure withdrawal of the catheter through the
introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.
If contrast is present, push the balloon out of the sheath and then completely
evacuate the contrast before proceeding to withdraw the balloon.
6. If resistance is still felt during post procedure withdrawal of the catheter, it is
recommended to remove the balloon catheter and guidewire/introducer sheath as
a single unit.
7. In the very unlikely event of balloon burst or rupture, balloon could be more
difficult to remove through the sheath and could require introducer sheath
removal.
8. Do not torque, excessively bend catheter or continue to use if the shaft has been
bent or kinked.
9. Prior to re-insertion through the introducer sheath, the balloon should be wiped
clean with gauze and rinsed with sterile normal saline.
10. Do not remove guidewire from catheter during procedure.
11. Dilation procedures should be conducted under high-quality fluoroscopic
guidance.
12. Careful attention must be paid to the maintenance of tight catheter connections.
Aspirate before proceeding to avoid air introduction into the system.
13. If inflating balloon in patient to facilitate re-folding, ensure balloon is positioned so
that it can be inflated safely.
Potential Adverse Reactions
The complications which may result from a percutaneous transluminal valvuloplasty
procedure include:
• Additional intervention
• Allergic reaction to drugs or contrast medium
• Aneurysm or psuedoaneurysm
• Arrhythmias
• Cardiovascular injury
• Conduction system injury
• Embolization
• Hematoma
• Hemorrhage, including bleeding at the puncture site
• Hypotension/hypertension
• Inflammation
• Occlusion
• Pain or tenderness
• Pneumothorax or hemothorax
• Sepsis/infection
• Shock
• Short term hemodynamic deterioration
• Stroke
• Thrombosis
• Valvular tearing or trauma
• Vessel dissection, perforation, rupture, or spasm
Directions for Use
Handling & Storage
Store in a cool, dry, dark place. Do not store near radiation or ultra-violet light
sources.
Rotate inventory so that the catheters and other dated products are used prior to the
“Use By” date.
Do not use if packaging is damaged or opened.
Equipment for Use
• Contrast medium
• Sterile saline solution
• Luer lock syringe/inflation device with manometer (50 ml or larger)
• Appropriate introducer sheath and dilator set
• .035" guidewire
• 3-way high pressure stopcock
Dilatation Catheter Preparation
1. Remove catheter from package. Verify the balloon size is suitable for the
procedure and the selected accessories accommodate the catheter as labeled.
2. Keep balloon guard on balloon until removing it immediately prior to inserting
catheter into introducer.
