2026 data FDA MAUDE openFDA

Drug-Coated Peripheral Transluminal Angioplasty Catheter

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 Drug-Coated Peripheral Transluminal Angiopl… LIGHT-BOOK · MAUDE

#890 of 1000 · 476 reports · 2017–2026

  • BOOK 476 reports
  • RANK #890 of 1000
  • DEATH 8 death-typed
  • INJ 380 injury-typed
  • MALF 88 malfunction
  • SPAN 2017–2026
  • PEAK 2025: 273
  • PHOTO Container

Nearest event-volume peer: Container, Specimen, Sterile (0 report gap)

Drug-Coated Peripheral Transluminal Angioplasty Catheter sits #890 of 1000 among tracked device types with 476 MAUDE reports spanning 2017–2026. 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 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 79.8% corpus 30.4% · above corpus mean (+49.4 pp)
  • MALF 18.5% corpus 64.5% · below corpus mean (-46.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 70% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 99% of manufacturer-tagged reports · Top event location is 88% of location-tagged rows .

Drug-Coated Peripheral Transluminal Angiopl… in the event-volume neighbourhood

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

reports

What this shows Drug-Coated Peripheral Transluminal Angioplasty Catheter carries 476 MAUDE reports, ranked #890 of 1000.

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

Event Types

Injury 380 (79.8%)
Malfunction 88 (18.5%)
Death 8 (1.7%)

Patient Outcomes

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

Required Intervention 353 (68.7%)
71 (13.8%)
Other 33 (6.4%)
R 26 (5.1%)
Death 12 (2.3%)
O 7 (1.4%)
Hospitalization 6 (1.2%)
D 3 (0.6%)
H 1 (0.2%)
L 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 379
Material Rupture 30
Burst Container or Vessel 20
Difficult to Remove 18
Deflation Problem 12
Inflation Problem 12
Device-Device Incompatibility 11
Detachment of Device or Device Component 10
Leak/Splash 9
Material Separation 7
Material Split, Cut or Torn 6
Retraction Problem 5
Insufficient Information 4
Material Deformation 4
Device Markings/Labelling Problem 3
Entrapment of Device 3
Improper or Incorrect Procedure or Method 3
Material Twisted/Bent 3
Break 2
Crack 2

Yearly Trend

17
2017: 2
18
2018: 11
19
2019: 10
20
2020: 16
21
2021: 24
22
2022: 27
23
2023: 31
24
2024: 65
25
2025: 273
26
2026: 17

Related Entities for Drug-Coated Peripheral Transluminal Angioplasty Catheter

Event Locations

421 (88.4%)
I 38 (8.0%)
HOSPITAL 16 (3.4%)
NO INFORMATION 1 (0.2%)

Compare MEDTRONIC IRELAND vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Drug-Coated Peripheral Transluminal Angiopl…, 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 (476 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Disclaimer: MAUDE figures for Drug-Coated Peripheral Transluminal Angiopl… 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 Drug-Coated Peripheral Transluminal Angiopl…; 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.