2026 data FDA MAUDE openFDA FDA Class III

Drug-Eluting Percutaneous Transluminal Coronary 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 Percutaneous Transluminal Coro… LIGHT-BOOK · MAUDE

#844 of 1000 · 578 reports · 2024–2026

  • BOOK 578 reports
  • RANK #844 of 1000
  • DEATH 68 death-typed
  • INJ 176 injury-typed
  • MALF 334 malfunction
  • SPAN 2024–2026
  • PEAK 2025: 230
  • PHOTO Microspheres Radionuc…

Nearest event-volume peer: Microspheres Radionuclide (0 report gap)

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter sits #844 of 1000 among tracked device types with 578 MAUDE reports spanning 2024–2026. 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 →

Death-coded reports run above the device-type norm

Drug-Eluting Percutaneous Transluminal Coro… carries 11.8% DEATH-coded reports, 10.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 11.8% corpus 1.5% · above corpus mean (+10.3 pp)
  • INJ 30.4% corpus 30.3% · near corpus mean (+0.2 pp)
  • MALF 57.8% corpus 64.8% · below corpus mean (-7.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 100% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Drug-Eluting Percutaneous Transluminal Coro… in the event-volume neighbourhood

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

reports

What this shows Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter carries 578 MAUDE reports, ranked #844 of 1000.

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

Event Types

Malfunction 334 (57.8%)
Injury 176 (30.4%)
Death 68 (11.8%)

Patient Outcomes

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

346 (58.0%)
Required Intervention 107 (17.9%)
Death 58 (9.7%)
Other 35 (5.9%)
Hospitalization 17 (2.8%)
H 16 (2.7%)
R 16 (2.7%)
D 2 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 260
Material Rupture 189
Break 76
Failure to Advance 67
Nonstandard Device 29
Difficult to Advance 28
Entrapment of Device 28
Difficult to Remove 19
Inflation Problem 16
Deformation Due to Compressive Stress 10
Material Deformation 10
Physical Resistance/Sticking 9
Device-Device Incompatibility 8
Material Integrity Problem 8
Failure to Deflate 6
Leak/Splash 6
Mechanical Jam 6
Detachment of Device or Device Component 5
Material Separation 4
Contamination 3

Yearly Trend

24
2024: 141
25
2025: 230
26
2026: 207

Related Entities for Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Top Manufacturers

Event Locations

578 (100.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drug-Eluting Percutaneous Transluminal Coro…: 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 (578 here).

Similar death-typed counts

Nearest other device types by death-typed report count (68 here), distinct from the volume row.

Disclaimer: MAUDE figures for Drug-Eluting Percutaneous Transluminal Coro… 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 Percutaneous Transluminal Coro…; 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.