Bard Peripheral Vascular True Instructions For Use Manual
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ENGLISHINSTRUCTIONS FOR USECAUTION: Federal (U.S.A.) law restricts this device to sale by or on the orderof a physician.Device DescriptionThe True™ DilaTaTion Balloon Valvuloplasty Catheter is an over-the-wire coaxialcatheter with a balloon fixed at the tip. The catheter is available in 110cm and 55cmlengths, and has two lumens: one lumen is used to inflate and deflate the balloonand the other permits the use of a guidewire to position the catheter. The ballooninflation luer-lock hub (angled) connects to a syringe inflation device to deliverradiopaque contrast media for inflation. The guidewire luer-lock hub (straight)connects to the guidewire lumen. The balloon is non-compliant and is designed toreach a known diameter and length when inflated within the specified pressure range.Two radiopaque marker bands are provided for fluoroscopic positioning of the deviceacross the aortic valve. These bands are positioned at the proximal and distal balloonshoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflationpressure, recommended introducer size, and recommended guidewire size areindicated on the package label.Indications for UseThe True™ DilaTaTion Balloon Valvuloplasty Catheter is indicated for balloon aorticvalvuloplasty.ContraindicationsThe True™ DilaTaTion Balloon Valvuloplasty Catheter is contraindicated for use inpatients with annular dimensions < 18 mm.Warnings1. Contents supplied STERILE using ethylene oxide (EO). Non-pyrogenic. Donot use if sterile barrier is opened or damaged. Single patient use only. Donot reuse, reprocess or re-sterilize.2. This device has been designed for single use only. Reusing this medicaldevice bears the risk of cross-patient contamination as medical devices– particularly those with long and small lumina, joints, and/or crevicesbetween components – are difficult or impossible to clean once body fluidsor tissues with potential pyrogenic or microbial contamination have hadcontact with the medical device for an indeterminable amount of time.The residue of biological material can promote the contamination of thedevice with pyrogens or microorganisms which may lead to infectiouscomplications.3. Do not resterilize. After resterilization, the sterility of the product is notguaranteed because of an indeterminable degree of potential pyrogenicor microbial contamination which may lead to infectious complications.Cleaning, reprocessing and/or resterilization of the present medical deviceincreases the probability that the device will malfunction due to potentialadverse effects on components that are influenced by thermal and/ormechanical changes.4. Catheter balloon inflation diameter must be carefully considered inselecting a particular size for any patient. It is critical to perform aclinical diagnostic determination of valve anatomical dimensions priorto use; imaging modalities such as transthoracic echocardiogram (TTE),computerized tomography (CT), angiography, and/or transesophagealechocardiogram (TEE) should be considered. The inflated balloon diametershould not be significantly greater than valvular diameter.5. When the catheter is exposed to the vascular system, it should bemanipulated while under high-quality fluoroscopic observation. Donot advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of theresistance before proceeding. Applying excessive force to the catheter canresult 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 catheterlumen by infusion. Doing so may cause catheter to rupture, resulting invessel trauma. Remove and replace catheter.7. Do not exceed the RBP recommended for this device. Balloon rupture mayoccur if the RBP rating is exceeded. To prevent over-pressurization, use ofa pressure monitoring device is recommended.8. After use, this product may be a potential biohazard. Handle and dispose ofin 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 proceduralinstructions related to selection and use of valvuloplasty balloon.Precautions1. Carefully inspect the catheter prior to use to verify that catheter has not beendamaged during shipment and that its size, shape and condition are suitable forthe 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 ofpercutaneous transluminal valvuloplasty.3. The minimal acceptable French size is printed on the package label. Do notattempt to pass the catheter through a smaller size sheath introducer thanindicated on the label.4. Use the recommended balloon inflation medium of 1/3 to 2/3 contrast to salineratio. Never use air or other gaseous medium to inflate the balloon.5. If resistance is felt during post procedure withdrawal of the catheter through theintroducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completelyevacuate the contrast before proceeding to withdraw the balloon.6. If resistance is still felt during post procedure withdrawal of the catheter, it isrecommended to remove the balloon catheter and guidewire/introducer sheath asa single unit.7. In the very unlikely event of balloon burst or rupture, balloon could be moredifficult to remove through the sheath and could require introducer sheathremoval.8. Do not torque, excessively bend catheter or continue to use if the shaft has beenbent or kinked.9. Prior to re-insertion through the introducer sheath, the balloon should be wipedclean 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 fluoroscopicguidance.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 sothat it can be inflated safely.Potential Adverse ReactionsThe complications which may result from a percutaneous transluminal valvuloplastyprocedure 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 spasmDirections for UseHandling & StorageStore in a cool, dry, dark place. Do not store near radiation or ultra-violet lightsources.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 stopcockDilatation Catheter Preparation1. Remove catheter from package. Verify the balloon size is suitable for theprocedure and the selected accessories accommodate the catheter as labeled.2. Keep balloon guard on balloon until removing it immediately prior to insertingcatheter into introducer. |
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