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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bronchial thermoplasty system
Definition Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.
Product CodeOOY
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
0 1 0 0 2 0

MDR Year MDR Reports MDR Events
2017 70 70
2018 46 46
2019 37 37
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 148 148
Misfire 2 2
Device Displays Incorrect Message 1 1
Device Operates Differently Than Expected 1 1
Flare or Flash 1 1
Material Deformation 1 1
Activation Problem 1 1
Device Alarm System 1 1
Break 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Asthma 56 56
No Code Available 37 37
Unspecified Infection 17 17
Pneumothorax 8 8
Bronchitis 8 8
Respiratory Distress 7 7
Pneumonia 7 7
Dyspnea 6 6
Bacterial Infection 5 5
Hemoptysis 5 5
Hemorrhage/Bleeding 4 4
Chest Pain 4 4
Respiratory Tract Infection 3 3
No Known Impact Or Consequence To Patient 3 3
Hypoxia 3 3
Fever 2 2
No Information 2 2
Bronchospasm 2 2
Headache 1 1
Infarction, Cerebral 1 1
Airway Obstruction 1 1
Atrial Fibrillation 1 1
Inflammation 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1
Stenosis 1 1
Discomfort 1 1

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