2026 data FDA MAUDE openFDA

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

#289 of 1000 · 5,692 reports · 2015–2026

  • BOOK 5,692 reports
  • RANK #289 of 1000
  • DEATH 526 death-typed
  • INJ 3,822 injury-typed
  • MALF 1,343 malfunction
  • SPAN 2015–2026
  • PEAK 2019: 1,054
  • PHOTO Blade

Nearest event-volume peer: Blade, Saw, General & Plastic Surgery, Surgical (9 report gap)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter sits #289 of 1000 among tracked device types with 5,692 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 →

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 9.2% corpus 1.5% · above corpus mean (+7.7 pp)
  • INJ 67.1% corpus 30.4% · above corpus mean (+36.7 pp)
  • MALF 23.6% corpus 64.5% · below corpus mean (-40.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 70% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 66% of manufacturer-tagged reports · Top event location I is 48% 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 5,692 MAUDE reports, ranked #289 of 1000.

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

Event Types

Injury 3,822 (67.1%)
Malfunction 1,343 (23.6%)
Death 526 (9.2%)
1 (0.0%)

Patient Outcomes

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

Required Intervention 2,433 (34.8%)
1,378 (19.7%)
R 1,159 (16.6%)
Hospitalization 1,106 (15.8%)
Other 635 (9.1%)
Death 120 (1.7%)
O 69 (1.0%)
H 63 (0.9%)
Life Threatening 10 (0.1%)
D 4 (0.1%)
L 4 (0.1%)
S 3 (0.0%)
Disability 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,835
Material Rupture 495
Inflation Problem 229
Burst Container or Vessel 171
Material Twisted/Bent 141
Difficult to Remove 102
Leak/Splash 101
Deflation Problem 79
Detachment of Device or Device Component 70
Entrapment of Device 42
Defective Device 40
Failure to Deflate 32
Material Deformation 31
Occlusion Within Device 27
Insufficient Information 26
Device-Device Incompatibility 23
Difficult to Advance 19
Material Integrity Problem 18
Break 17
Failure to Advance 16

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: 432
25
2025: 428
26
2026: 67

Related Entities for Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Top Manufacturers

Event Locations

I 2,710 (47.6%)
1,982 (34.8%)
HOSPITAL 995 (17.5%)
NO INFORMATION 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare MEDTRONIC IRELAND vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Drug-Eluting Peripheral Transluminal Angiop…, 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 (5,692 here).

Similar death-typed counts

Nearest other device types by death-typed report count (526 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.