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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Catheter LIGHT-BOOK · MAUDE

#250 of 1000 · 7,318 reports · 2008–2026

  • BOOK 7,318 reports
  • RANK #250 of 1000
  • DEATH 45 death-typed
  • INJ 405 injury-typed
  • MALF 6,867 malfunction
  • SPAN 2008–2026
  • PEAK 2025: 1,004
  • PHOTO Abutment

Nearest event-volume peer: Abutment, Implant, Dental, Endosseous (7 report gap)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring sits #250 of 1000 among tracked device types with 7,318 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 →

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 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 5.5% corpus 30.4% · below corpus mean (-24.9 pp)
  • MALF 93.8% corpus 64.5% · above corpus mean (+29.3 pp)

Lead product-problem code Material Rupture is 64% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 84% of manufacturer-tagged reports · Top event location is 54% 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 7,318 MAUDE reports, ranked #250 of 1000.

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

Event Types

Malfunction 6,867 (93.8%)
Injury 405 (5.5%)
Death 45 (0.6%)
1 (0.0%)

Patient Outcomes

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

6,813 (92.6%)
Required Intervention 212 (2.9%)
Other 173 (2.4%)
Hospitalization 47 (0.6%)
R 38 (0.5%)
Death 38 (0.5%)
O 11 (0.1%)
Life Threatening 10 (0.1%)
D 6 (0.1%)
L 4 (0.1%)
H 3 (0.0%)

Top Product Problems

Material Rupture 5,087
Break 505
Failure to Advance 370
Adverse Event Without Identified Device or Use Problem 360
Difficult to Remove 223
Entrapment of Device 196
Detachment of Device or Device Component 195
Inflation Problem 169
Leak/Splash 151
Material Deformation 131
Material Integrity Problem 115
Difficult to Advance 90
Nonstandard Device 89
Device Dislodged or Dislocated 63
Detachment Of Device Component 47
Deflation Problem 43
Fluid/Blood Leak 41
Material Puncture/Hole 41
Physical Resistance/Sticking 36
Material Separation 34

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: 145

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

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 5,806
BOSTON SCIENTIFIC - GALWAY 1,095

Event Locations

3,916 (53.5%)
I 3,372 (46.1%)
HOSPITAL 27 (0.4%)
NO INFORMATION 2 (0.0%)
OTHER 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - GALWAY →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, 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 (7,318 here).

Abutment, Implant, Dental, Endosseous 7,311 Catheter, Ultrasound, Intravascular 7,328 Cystoscope And Accessories, Flexible/Rigid 7,356 Lens, Intraocular, Toric Optics 7,256

Similar death-typed counts

Nearest other device types by death-typed report count (45 here), distinct from the volume row.

Apparatus 45 Electrode Measurement 45 Filler 45 Glue, Surgical, Arteries 45

Read our methodology - how this data is sourced, computed, and verified.

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.