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2026 data FDA MAUDE openFDA FDA Class III

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Percutaneous Cardiac Ablation Catheter For… LIGHT-BOOK · MAUDE

#230 of 1000 · 8,981 reports · 2024–2026

  • BOOK 8,981 reports
  • RANK #230 of 1000
  • DEATH 210 death-typed
  • INJ 4,034 injury-typed
  • MALF 4,734 malfunction
  • SPAN 2024–2026
  • PEAK 2025: 4,130
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Continuous Flush (16 report gap)

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation sits #230 of 1000 among tracked device types with 8,981 MAUDE reports spanning 2024–2026. 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

Percutaneous Cardiac Ablation Catheter For… carries 44.9% INJURY-coded reports, 14.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 44.9% corpus 30.3% · above corpus mean (+14.6 pp)
  • MALF 52.7% corpus 64.8% · below corpus mean (-12.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 55% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .

Percutaneous Cardiac Ablation Catheter For… in the event-volume neighbourhood

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

reports

What this shows Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation carries 8,981 MAUDE reports, ranked #230 of 1000.

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

Event Types

Malfunction 4,734 (52.7%)
Injury 4,034 (44.9%)
Death 210 (2.3%)
Other 3 (0.0%)

Patient Outcomes

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

4,860 (44.8%)
Required Intervention 1,741 (16.1%)
Hospitalization 876 (8.1%)
R 813 (7.5%)
H 736 (6.8%)
Other 710 (6.5%)
Life Threatening 419 (3.9%)
L 394 (3.6%)
Death 140 (1.3%)
O 84 (0.8%)
D 46 (0.4%)
Disability 14 (0.1%)
S 9 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,258
Entrapment of Device 1,013
Material Deformation 771
Material Twisted/Bent 706
Off-Label Use 608
Patient Device Interaction Problem 442
Device Contamination with Chemical or Other Material 441
Detachment of Device or Device Component 383
Material Integrity Problem 309
Contamination 252
Fluid/Blood Leak 252
Improper Flow or Infusion 219
Nonstandard Device 196
Use of Device Problem 172
Break 161
Difficult to Flush 138
Difficult to Remove 135
Air/Gas in Device 126
Positioning Failure 125
Activation, Positioning or Separation Problem 112

Yearly Trend

24
2024: 1,430
25
2025: 4,130
26
2026: 3,421

Related Entities for Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 4,659
MEDTRONIC CRYOCATH LP 1,975
MEDTRONIC, INC. 723
BIOSENSE WEBSTER INC 549
MEDTRONIC IRELAND 300
ABBOTT MEDICAL 121
Medtronic CryoCath LP 49
Biosense Webster Inc 19
Medtronic Ireland 18

Event Locations

8,860 (98.7%)
HOSPITAL 121 (1.3%)

Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC CRYOCATH LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Percutaneous Cardiac Ablation Catheter For…: 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 (8,981 here).

Catheter, Continuous Flush 8,965 Negative Pressure Wound Therapy Powered Suc… 9,164 Controller 9,165 Intervertebral Fusion Device With Bone Graft 9,183

Similar death-typed counts

Nearest other device types by death-typed report count (210 here), distinct from the volume row.

Stent, Iliac 211 Compressor, Cardiac, External 206 Heparin, Vascular Access Flush 206 Patch 215

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

Disclaimer: MAUDE figures for Percutaneous Cardiac Ablation Catheter For… 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 Percutaneous Cardiac Ablation Catheter For…; 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.