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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 4 4 4 3 1 1 0 0 1 0 0 2 1 0 0

MDR Year MDR Reports MDR Events
2014 57 57
2015 64 64
2016 60 60
2017 70 70
2018 46 46
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 328 328
Device Alarm System 5 5
Activation Problem 3 3
Material Integrity Problem 2 2
Misfire 2 2
Device Operates Differently Than Expected 2 2
Break 1 1
Insufficient Information 1 1
Defective Device 1 1
Failure to Deliver 1 1
Flare or Flash 1 1
Material Deformation 1 1
Appropriate Term/Code Not Available 1 1
Device Displays Incorrect Message 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Asthma 141 141
No Code Available 83 83
Unspecified Infection 31 31
Pneumonia 28 28
Dyspnea 15 15
Bronchitis 13 13
Hemoptysis 12 12
Pneumothorax 11 11
Chest Pain 11 11
Respiratory Failure 9 9
Respiratory Distress 9 9
Hemorrhage/Bleeding 6 6
Bacterial Infection 6 6
Respiratory Tract Infection 6 6
Hypoxia 5 5
Bronchospasm 5 5
Fever 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4
Atrial Fibrillation 3 3
Muscle Spasm(s) 3 3
Abscess 3 3
No Information 3 3
Burn(s) 2 2
Injury 2 2
Pain 2 2
Tachycardia 2 2
Stenosis 2 2
Ulcer 2 2
Fungal Infection 2 2
Airway Obstruction 2 2
Death 2 2
Anemia 1 1
Pleural Effusion 1 1
Septic Shock 1 1
Thrombosis 1 1
Viral Infection 1 1
Discomfort 1 1
Inflammation 1 1
Hematoma 1 1
Ulceration 1 1
Necrosis 1 1
Swelling/ Edema 1 1
Atrial Tachycardia 1 1
Pseudoaneurysm 1 1
Headache 1 1
Seizures 1 1
No Consequences Or Impact To Patient 1 1
Respiratory Insufficiency 1 1
Hemothorax 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-17-2013
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