Study: NCT03041233

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 833 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 833 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 833 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 833 at risk

Adverse event: Catheter Deformation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 833 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 833 at risk

Adverse event: Death
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 833 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 833 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Skin lesion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 833 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Car accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 833 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Perioperative infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Sinus dysfunction/asystole after interruption of flutter
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk

Adverse event: Muscle abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 833 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 833 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 833 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 833 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 833 at risk

Adverse event: Change in medical strategy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 833 at risk

Adverse event: Suspected bacterial endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 833 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 833 at risk