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<h2>Indications, Safety, and Warnings</h2> <h3>Caution</h3> <p>Federal (United States) law restricts this device to sale by or on the order of a physician.</p> <h3>Indications for use</h3> <p>The Cello™* balloon guide catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.</p> <h3>Precautions</h3> <ul> <li>Single use only. (If the product is to be re-used, it may cause infection to patients or damage to the product.)</li> <li>Store in a cool, dry, dark place.</li> <li>Do not use open or damaged packages.</li> <li>Use by “use by” date.</li> <li>Exposure to temperatures above 54 C (130 F) may damage the device and accessories. Do not autoclave.</li> <li>Upon removal from package, inspect the device to ensure it is not damaged.</li> <li>Do not expose the device to solvents.</li> <li>Do not use oily contrast media, consisting of ethyl ester of iodinated poppy-seed oil fatty acids, such as Lipiodol.</li> <li>The guidewire used with this system should incorporate a hydrophilic coating.</li> <li>Use the device in conjunction with fluoroscopic visualization and proper anticoagulation agents.</li> <li>Do not conduct MRI inspection while the product is in place.</li> <li>Torquing the guide catheter while kinked may cause damage that could result in separation of the catheter shaft.</li> <li>If a device becomes lodged in the guide catheter, or if guide catheter becomes severely kinked, withdraw the entire system (guide catheter, guidewire, and catheter sheath introducer).</li> <li>To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution through the guide catheter lumen.</li> <li>After use, dispose of this product and packaging based on the hospital, administrative and /or local government policy.</li> <li>If user and/or patient notice any serious incident that has occurred in relation to the device, please report to the manufacturer and the competent authority.</li> </ul> <h3>Contraindications</h3> <p>Use of the Cello™* balloon guide catheter is contraindicated under these circumstances</p> <ul> <li>Patients having acute cardiac infarction, severe irregular heartbeat, or abnormal serum electrolyte</li> <li>Patients having severe disorder of liver or kidney function</li> <li>Patients having a blood coagulation disorder or severe changes in coagulation for any reason</li> <li>Patients who cannot lie supine on the angiography bed because of congestive heart failure or respiratory problems</li> <li>Patients having irritation against contrast media</li> <li>Pregnant women</li> <li>Patients who are uncooperative during examination</li> </ul> <h3>Compatibility</h3> <p>Introducer sheath French size must be greater than or equal to balloon guide catheter French size. Maximum guidewire diameter is indicated on the product label.</p> <h3>Potential complications</h3> <p>Possible complications include, but are not limited to, the following:</p> <ul> <li>Infection</li> <li>Hematoma</li> <li>Distal embolization</li> <li>Vessel thrombosis</li> <li>Dissection</li> <li>False aneurysm formation</li> <li>Acute occlusion</li> <li>Clot formation</li> <li>Hemorrhage at the puncture site</li> <li>Intracranial hemorrhage</li> <li>Arterial rupture</li> <li>Arterial injury</li> <li>Arterial perforation</li> <li>Arteriovenous malformation</li> <li>Infection and pain</li> <li>Nausea and vomiting</li> <li>Blood pressure drop</li> <li>Arrhythmia</li> <li>Late bleeding</li> <li>Vasospasm</li> <li>Obstruction of a blood vessel</li> <li>Nervous system injury</li> <li>Stroke</li> <li>Death</li> </ul> <h3>Warnings</h3> <ul> <li>The Cello™* balloon guide catheter should only be used by physicians who have received appropriate training in interventional techniques.</li> <li>Do not reuse. Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning.</li> <li>Never advance or torque catheter against resistance without careful assessment of cause of resistance using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in damage to vessel or catheter.</li> <li>To reduce risk of complications due to slow balloon deflation, adhere to the following recommendations:<ul> <li>Wet the distal shaft with saline before passing into the introducer sheath.</li> <li>Minimize pushing forces on the shaft during advancement. These forces can cause wrinkles in the shaft that can slow balloon deflation.</li> <li>Do not use the device if the shaft is damaged during use.</li> <li>Prepare balloon according to the recommended procedure.</li> </ul> </li> <li>To reduce the risk of complications due to air emboli, remove air from the balloon according to the recommended procedure.</li> <li>Withdrawing the balloon through the introducer sheath may damage the balloon. Do not use the catheter again after withdrawing the balloon through the introducer sheath. </li> <li>To avoid balloon leakage, do not allow the balloon to contact calcified or stented arteries and do not allow the balloon to move during inflation.</li> <li>Do not use a device that has been damaged. Use of damaged devices may result in complications. </li> <li>Do not exceed maximum recommended balloon inflation volume as indicated on the label. Excess inflation volume may rupture the balloon. </li> <li>For through-lumen, do not exceed 2.07 MPa (300 psi) maximum recommended infusion pressure. Excess pressure may result in catheter rupture or tip detachment. </li> <li>If flow through the catheter becomes restricted do not attempt to clear catheter lumen by infusion. Doing so may cause the catheter to rupture, resulting in vessel trauma. Remove and replace the catheter.</li> <li>Do not steam shape the guide catheter.</li> <li>Do not pull the catheter at a force exceeding 3.5 N (0.35 kgf).</li> <li>Balloon should be inflated by one of the following:<ul> <li>Inflating the balloon with the dilator inserted (recommended)</li> <li>Inflating the balloon 3 seconds or more with 1 mL syringe.</li> </ul> </li> </ul> <p>See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.</p> <p>US-NNP-2400084 (v1.0)</p>

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