Indications, safety, and warnings for EPstar Fixed Electrophysiology Catheters

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 

INDICATIONS FOR USE

The EPstar Fixed Electrophysiology Catheter with Lumen can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

CONTRAINDICATIONS

The EPstar Fixed Electrophysiology Catheter with Lumen is recommended only for use in cardiac electrophysiological examinations.

WARNINGS

• DO NOT use if the physician has not undergone adequate training for cardiac electrophysiological examination techniques.
• Do not alter this device in any way.
• The EPstar Fixed Electrophysiology Catheter with Lumen is supplied STERILE using an ethylene oxide process.  Do not use if the package is damaged. 
• The EPstar Fixed Electrophysiology Catheter with Lumen is intended for single patient use only.  Do not attempt to sterilize and reuse the catheter. Reuse can cause the patient injury and/or the communication of infectious disease(s) from one patient to another. Reuse may result in patient complications.
• The EPstar Fixed Electrophysiology Catheter with Lumen must be used with the EPstar Electrophysiology Cable (DEX-10/DEX-14). Attempts to use it with other connector cables can result in electrocution of the patient and/or operator. 
• Avoid excessive force as it can cause breaks or leakage at the tip of the catheter. 
• Laboratory staff and patients can undergo significant x-ray exposure due to the continuous usage of fluoroscopic imaging.  This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure. 
• Be sure to read the package insert of the medical device that will be used concurrently.
• DO NOT force to push or pull this product in vessels if you feel resistance during insertion of this product [because there is a risk of damaging the blood vessel or heart chamber, and a situation requiring thoracotomy may occur]. 
• DO NOT reuse
• DO NOT resterilize 
• DO NOT use the product in the coronary arteries [it may induce myocardial infarction, arterial perforation, or cardiac tamponade, which may result in death]
• DO NOT use the product in the following patients:
  • Patients with excessive peripheral vascular diseases that prevent insertion of a sheath in an appropriate size [the vessel may be pierced]
  • Patients with excessive prolongation of coagulation time contraindicated for antiplatelet therapy and anticoagulation therapy [the antiplatelet therapy and anticoagulation therapy may be required when the product is used]
  • Patients with a serious allergy to drugs necessary for the procedure such as a contrast medium
  • Pregnant or possibly pregnant patients
  • Patients with bacteremia or sepsis
  • Patients with hypercoagulation or hypocoagulation causing coagulation disorder
  • Patients not eligible for thoracotomy procedures
  • Patients with tricuspid replacement if the product needs to pass a cardiac valve
  • Patients with severe circulation instability or shock
  • Patients with intracardiac mural thrombus, myocardial and unstable angina

PRECAUTIONS

• Do not attempt to use the EPstar Fixed Electrophysiology Catheter with Lumen or ancillary equipment before thoroughly reading the accompanying Instructions for Use.
• Use only for cardiac electrophysiological examinations.
• The sterile packaging should be visually inspected prior to use to detect any compromise.  Ensure that the packaging has not been damaged.  Do not use the equipment if the packaging has been compromised. 
• Visually inspect the EPstar Fixed Electrophysiology Catheter with Lumen prior to use.  Do not use the EPstar Fixed Electrophysiology Catheter with Lumen if there is any damage.
• Do not use the EPstar Fixed Electrophysiology Catheter with Lumen after the “Use By” date indicated on the label.
• Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the EPstar Fixed Electrophysiology Catheter with Lumen.
• Adequate filtering must be used to allow continuous monitoring of the electrocardiogram (ECG) signals during the procedure.
• Careful catheter manipulation must be performed to avoid cardiac damage, or tamponade. Catheter advancement should be done under fluoroscopic guidance. If resistance is encountered, DO NOT use excessive force to advance or withdraw the catheter.
• Do not bend the EPstar Fixed Electrophysiology Catheter with Lumen excessively.  Excessive bending or kinking of the catheter shaft may damage the integrity of the catheter and may cause patient injury including the detachment or fall of the catheter tip.  Care must be taken when handling the catheter. 
• Connect with other concurrently-used medical devices properly and perform maintenance and inspection appropriately to prevent microshocks. 
• Do not wipe the product with organic solvents such as alcohol as this may damage the product.
• When the product is inserted in a patient with pacemaker implant or implantable cardioverter defibrillator (ICD), pay attention to respective lead electrodes.
• Pay full attention to potential for suppression of pacing or malfunction of an ICD due to stimulation by electrophysiology studies of the heart; deal with the matter by changing the settings.
• It has been reported that polycarbonate, which is the raw material of the center port, may be damaged by contact with fat emulsion and drugs containing fat emulsion, oil ingredients such as castor oil, or drugs containing solubilizing agent such as surfactant or alcohol when these drugs are administered as well as by contact with a disinfectant containing alcohol. 
• Do NOT allow the metal parts of the connector, including the connecting pins and the junction of the connector parts, to contact any fluid including blood. 
• In the case that this product is used in combination with a heart stimulator or external pacemaker, pay careful attention to the location so that the electrodes of this product do not contact other leads. 
• Store under stable conditions, avoiding vibration and shock (including during transportation).
• Avoid storing in locations where chemical agents are stored or locations where any gas may be.
• Avoid exposure to direct sunlight.
• Do not bend or twist the catheter excessively.
• Do NOT handle device through the cable, as the device may act as a suspending mass.
• Use only with legally marketed diagnostic EP equipment. 
• Baylis Medical Company Inc. relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of an electrophysiology procedure.
• Diagnostic electrophysiology equipment is susceptible to electromagnetic interference. Do not operate near equipment that generate strong electromagnetic fields.

ADVERSE EVENTS

Adverse events that may occur while using the EPstar Fixed Electrophysiology Catheter with Lumen includes:

• Air embolism
• Difficulty in catheter retraction
• Death
• Ventricular fibrillation/tachycardia
• Sepsis, infections
• Arrhythmia with hemodynamic collapse
• Cardiac tamponade
• Myocardial infarction/ angina attack
• Pseudoaneurysm
• Access-site complication
• Hemorrhagic complication
• Bradycardia including atrioventricular block
• Thromboembolism
• Distal embolization (air, tissue, thrombus) in the lung
• Pneumothorax
• Subcutaneous hematoma formation
• Malfunction of implantable pacemaker/ ICD
• Cerebral infarction/cerebrovascular disorder
• Laceration, perforation and dissociation of blood vessel
• Cardiac valve damage such as valve insufficiency or valvular incompetence
• Hypertension/hypotension
• Cell damage

97186455 (Rev. A)