Indications, Safety, and Warnings
Indications (intended use)
The DiamondTemp™ ablation catheter is indicated for use in cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation when used in conjunction with the DiamondTemp™ RF generator and accessories (DiamondTemp™ catheter-to-RF generator cable, DiamondTemp™ GenConnect™ cable, DiamondTemp™ EGM cable, DiamondTemp™ irrigation pump, DiamondTemp™ irrigation tubing set) and compatible mapping system.
Contraindications
Use of the DiamondTemp™ catheter is contraindicated for: 1) patients with active systemic infection, 2) patients with prosthetic valves, 3) patients with intracardiac thrombus or myxoma or interatrial baffle or patch via transseptal approach, 4) patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation, 5) pregnant women and children < 18 years of age, and 6) patients who are hemodynamically unstable.
Warnings and precautions
Cardiac ablation procedures should be performed only by physicians trained in the techniques of radiofrequency (RF) catheter ablation in a fully equipped electrophysiology (EP) laboratory. The catheter is for single use only. Do not reprocess or resterilize. Reusing, reprocessing, or resterilizing may compromise the structural integrity of the device or lead to product failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or resterilizing may also create a risk of contamination of the device. Contamination may lead to injury, illness, or death of the patient. Pacemakers, implantable cardioverter defibrillators (ICDs), and leads can be adversely affected by RF signals. ICDs should be deactivated prior to ablation, precautions should be taken when the catheter is in close proximity to leads, and complete system analysis should be performed after ablation. Long-term risks of RF ablation lesions have not been established. Ablation too close to the esophageal area can result in esophageal fistula. Ablation near the AV node can cause permanent or partial conduction block. To ensure proper operation of the tissue contact impedance measurement function, all four electrodes and six thermocouples on the catheter tip must protrude from the distal tip of the guiding sheath. Carefully monitor the tissue contact impedance before delivery of RF energy. Do not place the RF electrode in proximity to any other mapping or ablation electrodes, as this may cause inadvertent, ineffective, or unsafe tissue ablation and may increase chances of char, coagulum, or steam pops. Although a higher contact impedance value typically indicates acceptable tissue contact, and low contact impedance values typically indicate lack of tissue contact, caution should be exercised. Areas of previously ablated tissue may also display a low contact impedance value. Other parameters, such as EGM, fluoroscopic images, and intracardiac ultrasound should be monitored before deciding to apply RF. Stimulation of cardiac tissues caused by pacing stimulus or RF energy may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns. Do not use the catheter for epicardial ablation. Using ablation parameters (such as temperature set-point, ablation duration, or irrigation flow rate) other than those recommended by Medtronic may be hazardous to patients. Exercise caution and sound medical reasoning when deciding to deviate from recommended parameters. Perform catheter advancement under fluoroscopic guidance in conjunction with internal contact, electrograms, and impedance monitoring to minimize the risk of cardiac damage, perforation, or tamponade. Tip-to-tissue contact impedance is actively monitored only before and after ablation. During ablation, use caution when the temperature drops suddenly. A drop in temperature may be associated with loss of tissue contact. In case of steam pop or automatic shut off, discontinue RF energy. Remove the catheter for visual inspection and check for coagulum, charring, or other catheter defects.
Manual prebending of the distal curve may damage the steering mechanism and may cause patient injury. Do not attempt ablation with the catheter without the use of the DiamondTemp™ irrigation pump and DiamondTemp™ generator and approved accessories. Do not attempt ablation without the use of the irrigation pump. Before attempting ablation, make sure the pump flow rate is at the minimum continuous flow and the pump is actively communicating with the generator. The potential adverse events that may be associated with ablation procedures can vary greatly in frequency and severity and may necessitate additional medical intervention, including surgery. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each DiamondTemp™ catheter, prior to use of the DiamondTemp™ generator or irrigation pump. The irrigation pump is designed for use only with sterile heparinized normal saline solution. Specified flow-rate accuracy may not be maintained when used with incompatible fluids or delivery devices. The air bubble detector is disabled during irrigation pump priming and purging functions. Do not prime or purge the catheter when it is inserted in the vasculature of the patient. Do not remove the irrigation tubing set from the irrigation pump while the tubing set is in-line with a catheter that is inside the patient. The DiamondTemp™ generator connection box E is to be used with the DiamondTemp™ ablation system and Ensite™ cardiac mapping and navigation systems configured to use NavX™ navigation technology. Use with other systems has not been assessed and may compromise patient or operator safety. Do not connect the generator connection box E to the Ensite™ amplifier with both the primary and secondary connectors. Only connect using one of the connector options.
Potential adverse events or potential complications
Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to, the following: abnormal vision; air embolism; anaphylaxis; anemia; aneurysm; angina; arrhythmia (including new or worsening of existing condition, or requiring cardioversion); arterial or venous thrombus; atrial septal defect; AV fistula; cardiac arrest; cardiac tamponade; catheter entrapment leading to valve or heart wall damage; catheter insertion site hematoma; chest pain (nonspecific); congestive heart failure exacerbation; component damage to ICD or pacemaker; coronary artery dissection; death; dislodgement of implantable device or permanent pacing lead; dizziness; embolic events, including infarction of other tissues, coronary, pulmonary, and bowel structures; endocarditis; esophageal damage or necrosis; exacerbation of COPD; exacerbation of pre-existing atrial fibrillation; fluid overload; gastroparesis or GI event; hemorrhage; hemothorax; hypotension; hypoxia; inadvertent AV block; infection; myocardial infarction; neck pain, back pain, or groin pain; palpitations; perforation (cardiac); pericardial effusion; pericarditis; peripheral venous thrombosis; phrenic nerve damage; pleural effusion; pneumonia; pneumothorax; pseudoaneurysm; pulmonary edema; pulmonary vein stenosis; radiation injury resulting in dermatitis, erythema, etc.; renal insufficiency or failure; respiratory failure; seizure; sepsis; skin burns; stroke or cerebrovascular incident; syncope; thromboembolic event; transient ischemic attack; vasovagal reaction; ventricular arrhythmia; vessel wall or valvular damage or insufficiency.
See the appropriate product device manuals for detailed information regarding the RF ablation procedure, indications (or intended use), contraindications, warnings, precautions, and potential complications/adverse events. See the appropriate electronic instructions for use (eIFUs) for the DiamondTemp™ catheters, DiamondTemp™ RF generator, DiamondTemp™ irrigation pump, DiamondTemp™ irrigation tubing set, DiamondTemp™ catheter-to-RF generator cable, DiamondTemp™ GenConnect™ cable, EGM cable, and DiamondTemp™ generator connection box E. or 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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