2026 data FDA MAUDE openFDA FDA Class III

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

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 Catheter LIGHT-BOOK · MAUDE

#251 of 1000 · 7,737 reports · 2008–2026

  • BOOK 7,737 reports
  • RANK #251 of 1000
  • DEATH 50 death-typed
  • INJ 449 injury-typed
  • MALF 7,237 malfunction
  • SPAN 2008–2026
  • PEAK 2025: 1,004
  • PHOTO Catheter, Embolectomy

Nearest event-volume peer: Catheter, Embolectomy (1 report gap)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring sits #251 of 1000 among tracked device types with 7,737 MAUDE reports spanning 2008–2026. 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 run above the device-type norm

Catheter carries 93.5% MALFUNCTION-coded reports, 28.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 5.8% corpus 30.3% · below corpus mean (-24.5 pp)
  • MALF 93.5% corpus 64.8% · above corpus mean (+28.7 pp)

Lead product-problem code Material Rupture is 62% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 85% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Catheter in the event-volume neighbourhood

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

reports

What this shows Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring carries 7,737 MAUDE reports, ranked #251 of 1000.

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

Event Types

Malfunction 7,237 (93.5%)
Injury 449 (5.8%)
Death 50 (0.6%)
1 (0.0%)

Patient Outcomes

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

7,049 (92.5%)
Required Intervention 227 (3.0%)
Other 177 (2.3%)
Hospitalization 47 (0.6%)
R 39 (0.5%)
Death 38 (0.5%)
Life Threatening 18 (0.2%)
O 11 (0.1%)
D 8 (0.1%)
H 4 (0.1%)
L 4 (0.1%)

Top Product Problems

Material Rupture 5,497
Break 583
Failure to Advance 419
Adverse Event Without Identified Device or Use Problem 390
Difficult to Remove 269
Entrapment of Device 217
Detachment of Device or Device Component 208
Inflation Problem 193
Leak/Splash 157
Nonstandard Device 155
Material Deformation 140
Material Integrity Problem 119
Difficult to Advance 112
Detachment Of Device Component 79
Device Dislodged or Dislocated 68
Material Separation 64
Fluid/Blood Leak 54
Deflation Problem 48
Material Puncture/Hole 48
Physical Resistance/Sticking 38

Yearly Trend

08
2008: 3
09
2009: 17
10
2010: 15
11
2011: 32
12
2012: 26
13
2013: 20
14
2014: 14
15
2015: 203
16
2016: 324
17
2017: 351
18
2018: 463
19
2019: 708
20
2020: 728
21
2021: 794
22
2022: 754
23
2023: 835
24
2024: 882
25
2025: 1,004
26
2026: 564

Reports in 2025 (1,004) held close to the prior two-year average of 859.

Related Entities for Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Event Locations

4,334 (56.0%)
I 3,371 (43.6%)
HOSPITAL 29 (0.4%)
NO INFORMATION 2 (0.0%)
OTHER 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - GALWAY →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter: 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 (7,737 here).

Similar death-typed counts

Nearest other device types by death-typed report count (50 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter 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 Catheter; 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.