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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)
2019 2020 2021 2022 2023 2024
0 0 2 1 0 0

MDR Year MDR Reports MDR Events
2019 37 37
2020 2 2
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 39 39
Device Alarm System 4 4
Activation Problem 3 3
Material Integrity Problem 2 2
Break 1 1
Defective Device 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Asthma 15 15
No Code Available 9 9
Unspecified Infection 8 8
Bronchitis 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Hypoxia 2 2
Bacterial Infection 2 2
Dyspnea 2 2
Pain 2 2
Pneumonia 2 2
Respiratory Distress 2 2
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Respiratory Tract Infection 1 1
Bronchospasm 1 1
Pneumothorax 1 1
Inflammation 1 1
Necrosis 1 1
Fever 1 1
Headache 1 1
Hemoptysis 1 1
Burn(s) 1 1
Respiratory Insufficiency 1 1
Swelling/ Edema 1 1

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