Ten-Ten™ Duodecapolar Diagnostic Catheters

Prescriptive Information

Indications
The Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or recording of electrical potentials.

Contraindications
Caution should be exercised, in the use of this or any other catheter, in patients with prosthetic valves. Patients with recurrent sepsis or with hypercoaguable state should not be considered candidates for transvascular catheters, since the catheter could serve as a focal point for septic or blood thrombus formation.

Warnings
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. The device(s) should be used by physicians thoroughly trained in the techniques of invasive cardiology and in the specific approach to be used. Care must be taken to ensure that any equipment used in connection with the EP Catheters meets IEC 601-1 and IEC 601-1-2 Safety Standards. - The use of catheters or cables with unprotected male pin connectors presents a risk of electrical hazard. Inadvertent attachment of pin connectors to power supply sockets of connectors could result in electrocution of the patient or operator. Diagnostic electrophysiology involves x-ray exposure that present the potential risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam and intensity and duration of the fluoroscopic imaging. Steps should be taken to minimize this exposure as much as possible. Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be performed under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. This catheter is not indicated for use in Cardiac Ablation or Coronary Artery Mapping.

Potential Adverse Effects
The following potential risks or discomforts may be associated with diagnostic EP procedures. The frequency and severity of these adverse events can vary, and may necessitate additional medical intervention, including surgery:
Allergic reaction, Arrhythmias, Cardiac or respiratory arrest, Cardiac valve damage, Catheter entrapment/entanglement, Chest pain, Damage to vessel intima or cardiac structures, Death, Embolus, air embolus, Hematoma/ecchymosis, Hemorrhage, Hypotension, Infection, Myocardial infarction, Perforation, Pericardial effusion, Pericarditis/ pleuritis, Pneumothorax, Pseudoaneurysm, Pulmonary edema, Sinus or AV node injury, Stroke, Stroke or cerebral vascular accident, Tamponade, Thrombosis, Vasovagal reaction, X-ray exposure.

Cautions
Federal law (USA) restricts this device to sale by or on order of a physician. Read directions prior to use. Excessive bending or kinking of the catheter shaft may damage internal wires. Manual pre-bending of the distal curve can damage the steering mechanism and/or electrical wires, and may cause patient injury.

Trademark
Ten-Ten is a trademark of Irvine Biomedical, Inc. Pebax is a trademark of Arkema Corporation.