2026 data FDA MAUDE openFDA

Catheter, Percutaneous, 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, Percutaneous, Cutting/Scoring LIGHT-BOOK · MAUDE

#499 of 1000 · 1,892 reports · 2016–2026

  • BOOK 1,892 reports
  • RANK #499 of 1000
  • DEATH 1 death-typed
  • INJ 187 injury-typed
  • MALF 1,704 malfunction
  • SPAN 2016–2026
  • PEAK 2024: 537
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Emergency, Manual (Resuscitator) (28 report gap)

Catheter, Percutaneous, Cutting/Scoring sits #499 of 1000 among tracked device types with 1,892 MAUDE reports spanning 2016–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 9.9% corpus 30.4% · below corpus mean (-20.6 pp)
  • MALF 90.1% corpus 64.5% · above corpus mean (+25.6 pp)

Lead product-problem code Material Rupture is 60% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 75% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .

Catheter, Percutaneous, Cutting/Scoring in the event-volume neighbourhood

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

reports

What this shows Catheter, Percutaneous, Cutting/Scoring carries 1,892 MAUDE reports, ranked #499 of 1000.

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

Event Types

Malfunction 1,704 (90.1%)
Injury 187 (9.9%)
Death 1 (0.1%)

Patient Outcomes

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

1,613 (83.9%)
Required Intervention 124 (6.4%)
Other 120 (6.2%)
R 30 (1.6%)
Hospitalization 29 (1.5%)
O 4 (0.2%)
Death 2 (0.1%)
H 1 (0.1%)

Top Product Problems

Material Rupture 1,348
Adverse Event Without Identified Device or Use Problem 154
Difficult to Remove 116
Detachment of Device or Device Component 93
Leak/Splash 93
Device-Device Incompatibility 62
Break 49
Deflation Problem 49
Device Dislodged or Dislocated 41
Material Deformation 39
Fluid/Blood Leak 35
Failure to Advance 29
Inflation Problem 28
Entrapment of Device 25
Material Split, Cut or Torn 18
Failure to Deflate 14
Burst Container or Vessel 13
Difficult to Insert 13
Improper or Incorrect Procedure or Method 13
Retraction Problem 12

Yearly Trend

16
2016: 9
17
2017: 26
18
2018: 55
19
2019: 81
20
2020: 121
21
2021: 90
22
2022: 75
23
2023: 304
24
2024: 537
25
2025: 524
26
2026: 70

Related Entities for Catheter, Percutaneous, Cutting/Scoring

Event Locations

1,519 (80.3%)
I 354 (18.7%)
HOSPITAL 18 (1.0%)
NO INFORMATION 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Percutaneous, Cutting/Scoring, 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 (1,892 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Percutaneous, Cutting/Scoring 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, Percutaneous, Cutting/Scoring; 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.