Indications, Safety, and Warnings
Indications (or intended use)
The Achieve Advance™ Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording or stimulation only. The Achieve Advance™ mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
Contraindications
The catheter is contraindicated as follows: 1) For use as an ablation device, 2) For use with transseptal sheaths featuring side holes larger than 1.00 mm (0.04 in) in diameter, 3) Retrograde approach.
Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions: An active systemic infection, Left atrial thrombus, Pulmonary vein stents, Prosthetic heart valve (tissue or mechanical), Myxoma, Interatrial baffle or patch, Conditions where the manipulation of the catheter within the heart would be unsafe, Acute myocardial infarction.
Warnings and precautions
This catheter is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize these devices for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death. This equipment should be used only by or under the supervision of physicians trained in cardiac catheterization procedures. If the sterile packaging of the device is damaged, do not use. Do not connect the mapping catheter to a radiofrequency (RF) generator or use it to deliver RF energy.
Use of fluoroscopy during catheter manipulation and placement is strongly advised. Take all appropriate measures to minimize x-ray exposure to both patients and clinical staff.
Avoid positioning the catheter around the chordae tendineae as this increases the likelihood of catheter entrapment within the heart. Avoid catheter entanglement with other catheters, devices, or wires. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue). Introducing any catheter into the circulatory system entails the risk of air or gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences.
Use extreme care when manipulating the catheter. Lack of careful attention can result in injury such as perforation or tamponade. Do not use excessive force to advance or withdraw the catheter, especially if resistance is encountered. Do not use the catheter if it is kinked, damaged, or cannot be straightened. Bending or kinking the catheter shaft may compromise the structural integrity of the device and increase the risk of catheter failure. Use only isolated equipment (IEC 606011 Type CF equipment, or equivalent) with the mapping catheter. Do not allow the patient to contact grounded equipment that might produce electrical current leakage during ablation or DCCV (Direct Current CardioVersion). Disconnect the catheter from the catheter connecting cable prior to cardioversion/defibrillation. Do not touch the patient or the catheter during cardioversion/defibrillation.
Use the mapping catheter only with the Medtronic catheter connecting cable Model 2ACHC, and a compatible mating device with a minimum internal diameter of 1.12 mm (0.044 in) and standard 9 Fr hemostasis valve. The mapping catheter is compatible for use with, and may be used to support and position, all catheters in the Medtronic Arctic Front CryoAblation Catheter family. Cardiac catheterization procedures should be performed only in a fully equipped electrophysiology laboratory. Do not immerse the electrical connectors in fluids or solvents. Administer appropriate levels of peri-procedural anticoagulation therapy for patients undergoing left-sided and transseptal cardiac procedures. Always rotate the mapping catheter in a clockwise direction to prevent tissue damage. Keep in a dry location away from heat and all sources of light. Exposure to light may cause damage to the catheter. Do not expose the catheter to organic solvents such as alcohol.
Potential adverse events or potential complications
Potential adverse events associated with cardiac catheter procedures include, but are not limited to the following conditions: Access site vessel occlusion; Allergic reaction to x-ray contrast media; Arrhythmias, proarrhythmia; Arteriovenous fistula; Bleeding related to anticoagulation; Bradycardia; Cardiac perforation of the heart or other organs during transseptal puncture or other procedures; Cardiac tamponade; Cardiac thromboembolism; Cerebrovascular accident (CVA) or transient ischemic attack (TIA); Chest discomfort; Chronic cough; Death; Dislodgement of implantable cardioverter defibrillator (ICD) or permanent pacing leads; Fever; Heart failure; Hematoma; Hemoptysis; High creatinine phosphokinase or troponin level; Hypotension; Infections; Mitral valve trauma; Myocardial infarction or ischemia; Obstruction, perforation, damage, or spasm of the vascular system including the coronary circulation system; Pericarditis or endocarditis; Pleural or pericardial effusion; Pneumonia; Pulmonary embolism; Pulmonary infiltrates; Pulmonary vein narrowing or stenosis; Pseudoaneurysm in groin; Radiation injury or damage and late malignancy; Respiratory depression; Retroperitoneal bleed; Thrombotic or embolic events; Valvular insufficiency or damage; Vasovagal reaction.
Refer to the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com .
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
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