Adverse Events; How Supplied - Boston Scientific MAESTRO 4000 Manual De Instrucciones

ADVERSE EVENTS

Users should also read and understand the specific indications, contraindications, warnings, and precautions
included with any catheter used in conjunction with the System.
Potential adverse events associated with the use of the Maestro 4000™ Cardiac Ablation System are, but not
limited to, the following:
• Additional intervention required
• Arrhythmia
• Burns
• Cardiac Arrest
• Cardiac Tamponade
• Cerebral Vascular Accident (CVA)
• Complete Heart Block
• Conduction Pathway Injury
• Congestive Heart Failure
• Death
• Discomfort
• Edema
• Electrical Shock
• Embolism
• Esophagitis
• Exposure to Biohazardous Material
• Fistula
• Hematoma
• Infection

HOW SUPPLIED

The Maestro 4000 Cardiac Ablation System components are supplied as non-sterile in corrugated boxes.
Do not use if package is opened or damaged. Do not use if labeling is incomplete or illegible.
Handling and Storage
Operating Environment
Ambient Temperature: 10 °C to 40 °C
Relative Humidity: 30% to 75%
Atmospheric Pressure: 70 kPa to 106 kPa
Transport Environment
Temperature: -29 °C to 60 °C
Relative Humidity: 30% to 85%
Atmospheric Pressure: Uncontrolled
4
Black (K) ∆E ≤5.0
• Injury (Not Otherwise Specified) -
• Laceration
• Myocardial Infarction
• Myocardial Trauma
• Necrosis
• Nerve Injury
• Perforation
• Pericardial Effusion
• Pericarditis
• Pleural Effusion
• Prolonged Procedure
• Renal damage/failure
• Respiratory Distress/Insufficiency
• Swallowing Disorders
• Tissue Damage
• Transient Ischemic Attack (TIA)
• Vasospasm
• Vessel Occlusion
• Vessel Trauma
Storage Environment
Ambient Temperature: 20 °C to 30 °C
Relative Humidity: Uncontrolled
Atmospheric Pressure: Uncontrolled
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global