2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.1250 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Catheter, Percutaneous, Cutting/Scoring LIGHT-BOOK · MAUDE

#490 of 1000 · 2,083 reports · 2016–2026

  • BOOK 2,083 reports
  • RANK #490 of 1000
  • DEATH 2 death-typed
  • INJ 199 injury-typed
  • MALF 1,882 malfunction
  • SPAN 2016–2026
  • PEAK 2024: 537
  • PHOTO Hydrogel Spacer

Nearest event-volume peer: Hydrogel Spacer (4 report gap)

Catheter, Percutaneous, Cutting/Scoring sits #490 of 1000 among tracked device types with 2,083 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 →

Malfunction reports run above the device-type norm

Catheter, Percutaneous, Cutting/Scoring carries 90.4% MALFUNCTION-coded reports, 25.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 9.6% corpus 30.3% · below corpus mean (-20.7 pp)
  • MALF 90.4% corpus 64.8% · above corpus mean (+25.5 pp)

Lead product-problem code Material Rupture is 61% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 76% of manufacturer-tagged reports · Top event location is 82% 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 2,083 MAUDE reports, ranked #490 of 1000.

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

Event Types

Malfunction 1,882 (90.4%)
Injury 199 (9.6%)
Death 2 (0.1%)

Patient Outcomes

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

1,740 (84.5%)
Required Intervention 129 (6.3%)
Other 122 (5.9%)
R 30 (1.5%)
Hospitalization 29 (1.4%)
O 4 (0.2%)
Life Threatening 3 (0.1%)
Death 2 (0.1%)
H 1 (0.0%)

Top Product Problems

Material Rupture 1,499
Adverse Event Without Identified Device or Use Problem 162
Difficult to Remove 125
Detachment of Device or Device Component 104
Leak/Splash 93
Device-Device Incompatibility 66
Break 54
Deflation Problem 50
Device Dislodged or Dislocated 45
Material Deformation 41
Fluid/Blood Leak 38
Inflation Problem 30
Failure to Advance 29
Entrapment of Device 26
Material Split, Cut or Torn 18
Insufficient Device Problem Information 17
Failure to Deflate 16
Improper or Incorrect Procedure or Method 14
Burst Container or Vessel 13
Difficult to Insert 13

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: 261

Reports in 2025 (524) held close to the prior two-year average of 421.

Related Entities for Catheter, Percutaneous, Cutting/Scoring

Event Locations

1,708 (82.0%)
I 354 (17.0%)
HOSPITAL 20 (1.0%)
NO INFORMATION 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Percutaneous, Cutting/Scoring: 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 (2,083 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 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.