2023 data FDA MAUDE openFDA

Bronchial Thermoplasty System

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Bronchial Thermoplasty System LIGHT-BOOK · MAUDE

#872 of 1000 · 500 reports · 2010–2023

  • BOOK 500 reports
  • RANK #872 of 1000
  • DEATH 3 death-typed
  • INJ 483 injury-typed
  • MALF 14 malfunction
  • SPAN 2010–2023
  • PEAK 2013: 82
  • PHOTO Bone Grafting Material

Nearest event-volume peer: Bone Grafting Material, Synthetic (1 report gap)

Bronchial Thermoplasty System sits #872 of 1000 among tracked device types with 500 MAUDE reports spanning 2010–2023. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 96.6% corpus 30.4% · above corpus mean (+66.2 pp)
  • MALF 2.8% corpus 64.5% · below corpus mean (-61.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 91% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - CORK accounts for 58% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Bronchial Thermoplasty System in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Bronchial Thermoplasty System carries 500 MAUDE reports, ranked #872 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 483 (96.6%)
Malfunction 14 (2.8%)
Death 3 (0.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Hospitalization 306 (47.3%)
Required Intervention 148 (22.9%)
R 144 (22.3%)
Other 23 (3.6%)
20 (3.1%)
Death 3 (0.5%)
H 1 (0.2%)
L 1 (0.2%)
O 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 209
Device Alarm System 5
Activation Problem 3
Material Integrity Problem 2
Misfire 2
Appropriate Term/Code Not Available 1
Break 1
Defective Device 1
Device Displays Incorrect Message 1
Device Operates Differently Than Expected 1
Failure to Deliver 1
Flare or Flash 1
Material Deformation 1

Yearly Trend

10
2010: 1
11
2011: 8
12
2012: 67
13
2013: 82
14
2014: 57
15
2015: 64
16
2016: 60
17
2017: 70
18
2018: 46
19
2019: 37
20
2020: 2
22
2022: 5
23
2023: 1

Related Entities for Bronchial Thermoplasty System

Event Locations

I 253 (50.6%)
241 (48.2%)
HOSPITAL 4 (0.8%)
NO INFORMATION 2 (0.4%)

Compare BOSTON SCIENTIFIC - CORK vs BOSTON SCIENTIFIC - MARLBOROUGH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Bronchial Thermoplasty System, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (500 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Disclaimer: MAUDE figures for Bronchial Thermoplasty System are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Bronchial Thermoplasty System; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.