Explorer 360™ and 360 Jr™ 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, contact 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 risk of vascular perforation exists with any intracardiac catheter. Do not advance the catheter if resistance is encountered. - This catheter is not indicated for use in cardiac ablation or coronary artery mapping procedures. - This use of catheters or cables with unprotected male connectors present 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. The users of components with unprotected male connectors must exercise caution during device set-up to prevent patient or operator injury.

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. Strict adherence to the foregoing instructions before use will help reduce the incidence of complications.
Allergic reaction
Arrhythmias
Cardiac or respiratory arrest
Cardiac valve damage
Catheter entrapment/entanglement
Chest pain
Damage to vessel intima or cardiac ultrastructures
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.