Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
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
#288 of 1000 · 5,946 reports · 2006–2026
- BOOK 5,946 reports
- RANK #288 of 1000
- DEATH 218 death-typed
- INJ 2,808 injury-typed
- MALF 2,893 malfunction
- SPAN 2006–2026
- PEAK 2011: 486
- PHOTO Instrument
Nearest event-volume peer: Instrument, Vitreous Aspiration And Cutting, Ac-Powered (4 report gap)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter sits #288 of 1000 among tracked device types with 5,946 MAUDE reports spanning 2006–2026. 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 →
Injury-coded reports run above the device-type norm
Catheter carries 47.2% INJURY-coded reports, 16.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.7% corpus 1.5% · above corpus mean (+2.2 pp)
- INJ 47.2% corpus 30.3% · above corpus mean (+16.9 pp)
- MALF 48.7% corpus 64.8% · below corpus mean (-16.2 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 35% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 36% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Mesh
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
5,966 reports
- Catheter (this)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
5,946 reports
- Instrument
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
5,942 reports
- Stopcock
Stopcock, I.V. Set
5,928 reports
- Drug-Eluting…
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
5,888 reports
- Blade
Blade, Saw, General & Plastic Surgery, Surgical
5,861 reports
What this shows Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter carries 5,946 MAUDE reports, ranked #288 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 fell to 196 in 2025, down from an average of 305 in the two years before.
Related Entities for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BIOSENSE WEBSTER INC →
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 (5,946 here).
Similar death-typed counts
Nearest other device types by death-typed report count (218 here), distinct from the volume row.
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.