Catheter, Coronary, Atherectomy
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, Coronary, Atherectomy MID-BOOK · MAUDE
#196 of 1000 · 11,823 reports · 1993–2026
- BOOK 11,823 reports
- RANK #196 of 1000
- DEATH 874 death-typed
- INJ 4,368 injury-typed
- MALF 6,536 malfunction
- SPAN 1993–2026
- PEAK 2021: 901
- PHOTO System
Nearest event-volume peer: System, Hemodynamic, Implantable (24 report gap)
Catheter, Coronary, Atherectomy sits #196 of 1000 among tracked device types with 11,823 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm
Catheter, Coronary, Atherectomy carries 55.3% MALFUNCTION-coded reports, 9.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 7.4% corpus 1.5% · above corpus mean (+5.9 pp)
- INJ 36.9% corpus 30.3% · above corpus mean (+6.7 pp)
- MALF 55.3% corpus 64.8% · below corpus mean (-9.5 pp)
Lead product-problem code Entrapment of Device is 22% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 59% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .
Catheter, Coronary, Atherectomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Intracranial…
Intracranial Aneurysm Flow Diverter
11,926 reports
- Tampon
Tampon, Menstrual, Unscented
11,865 reports
- Catheter (this)
Catheter, Coronary, Atherectomy
11,823 reports
- System
System, Hemodynamic, Implantable
11,799 reports
- Mesh
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
11,654 reports
- Mesh, Surgical
Mesh, Surgical
11,595 reports
What this shows Catheter, Coronary, Atherectomy carries 11,823 MAUDE reports, ranked #196 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (873) held close to the prior two-year average of 752.
Related Entities for Catheter, Coronary, Atherectomy
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - CORK →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Coronary, Atherectomy: 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 (11,823 here).
Similar death-typed counts
Nearest other device types by death-typed report count (874 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Coronary, Atherectomy 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, Coronary, Atherectomy; 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.