Study: NCT01297322

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal Insufficiency
Frequency: 1 affected / 142 at risk

Adverse event: Access site re-bleeding after initial hemostasis confirmed for 5 minutes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Access site re-bleeding after initial hemostasis confirmed for 5 minutes
Frequency: 4 affected / 142 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Angina
Frequency: 1 affected / 142 at risk

Adverse event: Dermatologic disorders / symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermatologic disorders / symptoms
Frequency: 1 affected / 142 at risk

Adverse event: Discomfort - nonaccess site
Serious: no
Organ System: General disorders
Notes: Discomfort - nonaccess site
Frequency: 1 affected / 142 at risk

Adverse event: GI disorders/symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI disorders/symptoms
Frequency: 4 affected / 142 at risk

Adverse event: General disorder/respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: General disorder/respiratory
Frequency: 1 affected / 142 at risk

Adverse event: General disorders/symptoms
Serious: no
Organ System: General disorders
Notes: General disorders/symptoms
Frequency: 2 affected / 142 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 4 affected / 142 at risk

Adverse event: Hematoma - access site
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hematoma - access site
Frequency: 2 affected / 142 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 1 affected / 142 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension
Frequency: 1 affected / 142 at risk

Adverse event: Neuro - other
Serious: no
Organ System: Nervous system disorders
Notes: Neuro - other
Frequency: 1 affected / 142 at risk

Adverse event: Ortho disorders/symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ortho disorders/symptoms
Frequency: 1 affected / 142 at risk

Adverse event: Pain - access site
Serious: no
Organ System: General disorders
Notes: Pain - access site
Frequency: 3 affected / 142 at risk

Adverse event: Pain - nonaccess site
Serious: no
Organ System: General disorders
Notes: Pain - nonaccess site
Frequency: 2 affected / 142 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 1 affected / 142 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Nervous system disorders
Notes: Vasovagal episode
Frequency: 2 affected / 142 at risk

Adverse event: Arterial Thrombosis - peripheral/ non-access site-related
Serious: no
Organ System: Vascular disorders
Notes: Arterial Thrombosis - peripheral/ non-access site-related
Frequency: 1 affected / 275 at risk

Adverse event: Embolization - peripheral non-access site-related
Serious: no
Organ System: Vascular disorders
Notes: Embolization - peripheral non-access site-related
Frequency: 1 affected / 275 at risk

Adverse event: Severe Hypotension Requiring Treatment
Serious: no
Organ System: Cardiac disorders
Notes: Severe Hypotension Requiring Treatment
Frequency: 3 affected / 275 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 275 at risk

Adverse event: Access site re-bleeding after initial hemostasis confirmed for 5 minutes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Access site re-bleeding after initial hemostasis confirmed for 5 minutes
Frequency: 7 affected / 275 at risk

Adverse event: Altered mental status
Serious: no
Organ System: Psychiatric disorders
Notes: Altered mental status
Frequency: 4 affected / 275 at risk

Adverse event: Access site-related tissue tract oozing - prolonged
Serious: no
Organ System: Surgical and medical procedures
Notes: Access site-related tissue tract oozing - prolonged
Frequency: 1 affected / 275 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Angina
Frequency: 3 affected / 275 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Atrial fibrillation
Frequency: 4 affected / 275 at risk

Adverse event: Cardiac disorders/symptoms
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac disorders/symptoms
Frequency: 3 affected / 275 at risk

Adverse event: Dermatologic disorders / symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermatologic disorders / symptoms
Frequency: 2 affected / 275 at risk

Adverse event: Discomfort - access site
Serious: no
Organ System: Surgical and medical procedures
Notes: Discomfort - access site
Frequency: 6 affected / 275 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Dizziness
Frequency: 1 affected / 275 at risk

Adverse event: ENT disorders/symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Notes: ENT disorders/symptoms
Frequency: 1 affected / 275 at risk

Adverse event: Ecchymosis - access site
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Ecchymosis - access site
Frequency: 1 affected / 275 at risk

Adverse event: Ecchymosis - nonaccess site
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Ecchymosis - nonaccess site
Frequency: 1 affected / 275 at risk

Adverse event: Erythema - access site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema - access site
Frequency: 1 affected / 275 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Fall
Frequency: 1 affected / 275 at risk

Adverse event: GI disorders/symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI disorders/symptoms
Frequency: 5 affected / 275 at risk

Adverse event: GU disorders/symptoms
Serious: no
Organ System: Renal and urinary disorders
Notes: GU disorders/symptoms
Frequency: 2 affected / 275 at risk

Adverse event: General disorders/symptoms
Serious: no
Organ System: General disorders
Notes: General disorders/symptoms
Frequency: 4 affected / 275 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 1 affected / 275 at risk

Adverse event: Hematoma - access site
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hematoma - access site
Frequency: 6 affected / 275 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Hematuria
Frequency: 1 affected / 275 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 1 affected / 275 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hypervolemia
Frequency: 2 affected / 275 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension
Frequency: 3 affected / 275 at risk

Adverse event: Infection - access site
Serious: no
Organ System: Infections and infestations
Notes: Infection - access site
Frequency: 1 affected / 275 at risk

Adverse event: Neuro - other
Serious: no
Organ System: Nervous system disorders
Notes: Neuro - other
Frequency: 2 affected / 275 at risk

Adverse event: Neurological deficit - TIA
Serious: no
Organ System: Nervous system disorders
Notes: Neurological deficit - TIA
Frequency: 1 affected / 275 at risk

Adverse event: Pain - access site
Serious: no
Organ System: General disorders
Notes: Pain - access site
Frequency: 2 affected / 275 at risk

Adverse event: Pain - nonaccess site
Serious: no
Organ System: General disorders
Notes: Pain - nonaccess site
Frequency: 6 affected / 275 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 3 affected / 275 at risk

Adverse event: Renal failure/insufficiency
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal failure/insufficiency
Frequency: 1 affected / 275 at risk

Adverse event: Respiratory disorders/symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory disorders/symptoms
Frequency: 4 affected / 275 at risk

Adverse event: Retroperitoneal bleeding (hematoma/hemorrhage)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Retroperitoneal bleeding (hematoma/hemorrhage)
Frequency: 1 affected / 275 at risk

Adverse event: Swelling - nonaccess site
Serious: no
Organ System: General disorders
Notes: Swelling - nonaccess site
Frequency: 1 affected / 275 at risk

Adverse event: Vascular repair - non-device related
Serious: no
Organ System: Vascular disorders
Notes: Vascular repair - non-device related
Frequency: 1 affected / 275 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Nervous system disorders
Notes: Vasovagal episode
Frequency: 1 affected / 275 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Ventricular arrhythmia
Frequency: 1 affected / 275 at risk