2026 data FDA MAUDE openFDA

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.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

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

#276 of 1000 · 6,348 reports · 2024–2026

  • BOOK 6,348 reports
  • RANK #276 of 1000
  • DEATH 156 death-typed
  • INJ 2,630 injury-typed
  • MALF 3,559 malfunction
  • SPAN 2024–2026
  • PEAK 2025: 4,131
  • PHOTO System

Nearest event-volume peer: System, Imaging, Pulsed Echo, Ultrasonic (13 report gap)

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation sits #276 of 1000 among tracked device types with 6,348 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 →

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 2.5% corpus 1.5% · above corpus mean (+0.9 pp)
  • INJ 41.4% corpus 30.4% · above corpus mean (+11.0 pp)
  • MALF 56.1% corpus 64.5% · below corpus mean (-8.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 61% 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 6,348 MAUDE reports, ranked #276 of 1000.

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

Event Types

Malfunction 3,559 (56.1%)
Injury 2,630 (41.4%)
Death 156 (2.5%)
Other 3 (0.0%)

Patient Outcomes

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

3,720 (48.1%)
Required Intervention 1,168 (15.1%)
Hospitalization 591 (7.6%)
R 545 (7.1%)
H 508 (6.6%)
Other 449 (5.8%)
L 264 (3.4%)
Life Threatening 259 (3.4%)
Death 121 (1.6%)
O 55 (0.7%)
D 33 (0.4%)
Disability 7 (0.1%)
S 6 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,110
Entrapment of Device 846
Material Deformation 599
Material Twisted/Bent 582
Off-Label Use 489
Detachment of Device or Device Component 331
Material Integrity Problem 303
Patient Device Interaction Problem 276
Device Contamination with Chemical or Other Material 264
Improper Flow or Infusion 219
Fluid/Blood Leak 191
Contamination 158
Positioning Failure 126
Difficult to Flush 121
Use of Device Problem 115
Break 112
Air/Gas in Device 108
Difficult to Remove 107
Activation, Positioning or Separation Problem 100
Nonstandard Device 94

Yearly Trend

24
2024: 1,430
25
2025: 4,131
26
2026: 787

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

Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC CRYOCATH LP →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Percutaneous Cardiac Ablation Catheter For…, 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 (6,348 here).

Similar death-typed counts

Nearest other device types by death-typed report count (156 here), distinct from the volume row.

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.