2026 data FDA MAUDE openFDA FDA Class III

Drug-Eluting 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-Eluting Peripheral Transluminal Angiop… LIGHT-BOOK · MAUDE

#291 of 1000 · 5,888 reports · 2015–2026

  • BOOK 5,888 reports
  • RANK #291 of 1000
  • DEATH 528 death-typed
  • INJ 3,924 injury-typed
  • MALF 1,435 malfunction
  • SPAN 2015–2026
  • PEAK 2019: 1,054
  • PHOTO Blade

Nearest event-volume peer: Blade, Saw, General & Plastic Surgery, Surgical (27 report gap)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter sits #291 of 1000 among tracked device types with 5,888 MAUDE reports spanning 2015–2026. 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 →

Malfunction reports sit below the device-type norm

Drug-Eluting Peripheral Transluminal Angiop… carries 24.4% MALFUNCTION-coded reports, 40.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 9.0% corpus 1.5% · above corpus mean (+7.5 pp)
  • INJ 66.6% corpus 30.3% · above corpus mean (+36.4 pp)
  • MALF 24.4% corpus 64.8% · below corpus mean (-40.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 69% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 65% of manufacturer-tagged reports · Top event location I is 46% of location-tagged rows .

Drug-Eluting Peripheral Transluminal Angiop… in the event-volume neighbourhood

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

reports

What this shows Drug-Eluting Peripheral Transluminal Angioplasty Catheter carries 5,888 MAUDE reports, ranked #291 of 1000.

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

Event Types

Injury 3,924 (66.6%)
Malfunction 1,435 (24.4%)
Death 528 (9.0%)
1 (0.0%)

Patient Outcomes

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

Required Intervention 2,502 (34.9%)
1,472 (20.5%)
R 1,167 (16.3%)
Hospitalization 1,111 (15.5%)
Other 641 (8.9%)
Death 121 (1.7%)
O 73 (1.0%)
H 64 (0.9%)
Life Threatening 10 (0.1%)
L 5 (0.1%)
D 4 (0.1%)
S 3 (0.0%)
Disability 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 4,306
Material Rupture 561
Inflation Problem 269
Burst Container or Vessel 191
Material Twisted/Bent 155
Leak/Splash 112
Difficult to Remove 110
Defective Device 90
Deflation Problem 88
Detachment of Device or Device Component 73
Entrapment of Device 44
Occlusion Within Device 40
Failure to Deflate 36
Material Deformation 35
Insufficient Device Problem Information 29
Device-Device Incompatibility 27
Difficult to Advance 21
Break 19
Material Integrity Problem 18
Failure to Advance 17

Yearly Trend

15
2015: 478
16
2016: 492
17
2017: 590
18
2018: 545
19
2019: 1,054
20
2020: 454
21
2021: 306
22
2022: 361
23
2023: 485
24
2024: 431
25
2025: 428
26
2026: 264

Reports in 2025 (428) held close to the prior two-year average of 458.

Related Entities for Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Top Manufacturers

Event Locations

I 2,710 (46.0%)
2,178 (37.0%)
HOSPITAL 995 (16.9%)
NO INFORMATION 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare MEDTRONIC IRELAND vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drug-Eluting Peripheral Transluminal Angiop…: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,888 here).

Similar death-typed counts

Nearest other device types by death-typed report count (528 here), distinct from the volume row.

Disclaimer: MAUDE figures for Drug-Eluting Peripheral Transluminal Angiop… 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-Eluting Peripheral Transluminal Angiop…; 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.