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INOUE BALLOON™ A

Balloon Catheter for BAV (Balloon Aortic Valvuloplasty)

INDICATION

INOUE BALLOON™ A is indicated for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.

CONTRAINDICATIONS

  1. Patients with aortic regurgitation degree of 3 or higher by Sellers classification as it may exacerbate aortic regurgitation and/or induce left heart failure.
  2. Patients suspected of forming a fresh left atrial thrombus as it may result in embolism.
  3. Patients with suspected thrombus on the valve as it may result in embolism.
  4. Patients with bacterial endocarditis as it may exacerbate infection.

WARNINGS

  1. Do not use after the "use before" date shown on the label preceded by the following symbol: hourglass.
  2. Do not reuse and do not resterilize. INOUE BALLOON™ A is intended for SINGLE USE ONLY. Discard the catheter and its accessories after procedure. Reuse may result in product damage and/or adverse events (i.e., infection, thrombosis, embolism, etc.)
  3. The catheter should only be used by physicians proficient in BAV procedure. Independent use should not be attempted by anyone not completely trained, as it may result in severe patient injury or death.
  4. This product contains natural rubber latex. Natural rubber latex may rarely cause allergic symptoms like itching, redness, urticaria, edema, fever, dyspnea, asthma-like symptoms, low blood pressure and shock. If those symptoms happen, stop using immediately and take appropriate actions.
  5. Do not use a guidewire that is bent. Replace it with a new one as soon as possible. Continued use of a bent guidewire may impede catheter movement or cause guidewire breakage.
  6. Balloon inflation diameter must be carefully considered in selecting a particular size for any patient, especially for patients with severe calcification, extensive calcification, narrowing of the sinus of valsalva or narrowing of the aorta. Ensure prior to use that the appropriate balloon size has been selected based on the patient's specific condition such as height and echocardiography results. Dilating the aortic orifice with a large balloon diameter may cause injury to the valve, balloon damage, mesh break or other adverse events and/or device problems. If a mesh break or any other problem occurs, immediately deflate and remove the balloon, and replace it with a new catheter.
  7. When expanding the balloon, begin with a smaller balloon diameter and increase the diameter if necessary. If the degree of valve stiffening, calcification, and subvalvular stenosis is significant, dilation can cause damage, resulting in regurgitation.
  8. If aortic regurgitation occurs or worsens after valvular dilation, discontinue subsequent dilation. Otherwise, it may cause further aortic regurgitation.
  9. Do not use guidewires made of nickel-titanium alloy. Breakage is difficult to predict and to visualize under fluoroscopy.
  10. If you use this device to support transcatheter aortic valve replacement (TAVR), please refer to the TAVR IFU for the additional steps related to the selection and use of valvuloplasty balloons.

PRECAUTIONS

  1. Before use

    Do not use if the package has been opened or damaged. Confirm before opening the sterile pouches. Confirm that the catheter and its accessories are functioning properly. Always keep extra sets of the products so that replacement can be made if necessary.

  2. During use
    1. Do not tap or hit on the catheter and its accessories (such as with forceps). This could cause damage to the catheter shaft, balloon, etc.
    2. Always perform advancement, manipulation and withdrawal of the INOUE BALLOON™ A and the guidewire under fluoroscopic guidance.
    3. Administer an adequate amount of heparin according to its IFU and the latest guidelines.
    4. Do not inflate the balloon beyond the maximum balloon inflation diameter (See II. DEVICE DESCRIPTION 4. Specification "Balloon available range"). Otherwise, it may cause damage to the device or patient injury. If strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before taking further action. If the cause of the resistance cannot be determined, withdraw the balloon catheter and guidewire.
    5. Ensure the guidewire is inserted in the catheter before pushing the inner tube of the catheter into the connector. If the guidewire is not in place, the balloon portion may bend at a sharp angle and make subsequent manipulation difficult.
    6. Do not twist the inner tube while elongating the balloon. If the inner tube is twisted, it will occlude and/or damage the guidewire lumen and this could make it impossible to advance or withdraw the guidewire.

POTENTIAL COMPLICATIONS, ADVERSE EFFECTS

  • Exacerbation of regurgitation
  • Arrhythmias
  • Blood vessel damage
  • Congestive heart attack and pulmonary edema
  • Myocardial damage, cardiac perforation, cardiac tamponade
  • Aortic valve damage
  • Ruptured chordae tendineae
  • Thrombosis, embolism, stroke, transient ischemic attack
  • Infection
  • Allergic reaction to contrast medium or device components
  • Hypotension
  • Respiratory arrest
  • Kidney failure
  • Vasovagal reaction
  • Bleeding or hematoma at the puncture site

DISCLAIMER OF WARRANTY AND LIMITATIONS OF REMEDY

  1. Toray will replace any defective the INOUE BALLOON™ A and set contents (e.g., damaged product), free of charge. In the event of a product complaint, the user is requested to return the INOUE BALLOON™ A and packaging materials so that the cause of the complaint may be fully investigated.
  2. Toray is not responsible for any damage caused due to improper handling, operation and storage, including use after the expiry date given on the product label, preceded by the symbol: hourglass.
  3. Toray is not responsible for any damage to the INOUE BALLOON™ A or its accessories caused by transportation, handling and storage at the health care facility, whether physical damage or human injury.
  4. Toray is not responsible for any damage caused by reprocessing or reuse of the INOUE BALLOON™ A or its accessories, whether physical damage or human injury.
  5. Toray is not responsible for any damage, whether physical damage or human injury, which may arise from the misuse of the INOUE BALLOON™ A (catheter, caliper and Syringe). Do not substitute with other manufacturers' products.
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