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2026 data FDA MAUDE openFDA FDA Class III

Cardiac Ablation Percutaneous Catheter

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 Cardiac Ablation Percutaneous Catheter MID-BOOK · MAUDE

#166 of 1000 · 16,442 reports · 1992–2026

  • BOOK 16,442 reports
  • RANK #166 of 1000
  • DEATH 724 death-typed
  • INJ 9,595 injury-typed
  • MALF 6,055 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 1,839
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (63 report gap)

Cardiac Ablation Percutaneous Catheter sits #166 of 1000 among tracked device types with 16,442 MAUDE reports spanning 1992–2026. 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

Cardiac Ablation Percutaneous Catheter carries 58.4% INJURY-coded reports, 28.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 58.4% corpus 30.3% · above corpus mean (+28.1 pp)
  • MALF 36.8% corpus 64.8% · below corpus mean (-28.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 28% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 65% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Cardiac Ablation Percutaneous Catheter in the event-volume neighbourhood

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

reports

What this shows Cardiac Ablation Percutaneous Catheter carries 16,442 MAUDE reports, ranked #166 of 1000.

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

Event Types

Injury 9,595 (58.4%)
Malfunction 6,055 (36.8%)
Death 724 (4.4%)
Other 49 (0.3%)
19 (0.1%)

Patient Outcomes

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

5,964 (22.3%)
R 5,763 (21.5%)
Life Threatening 3,869 (14.5%)
L 3,315 (12.4%)
Hospitalization 2,967 (11.1%)
Required Intervention 1,689 (6.3%)
Other 1,290 (4.8%)
H 939 (3.5%)
Death 626 (2.3%)
O 152 (0.6%)
D 116 (0.4%)
S 54 (0.2%)
Disability 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 4,118
Patient Device Interaction Problem 3,913
Insufficient Device Problem Information 1,075
Material Puncture/Hole 680
Incorrect, Inadequate or Imprecise Result or Readings 589
Contamination /Decontamination Problem 465
Failure to Sense 460
Device Operates Differently Than Expected 426
Device Displays Incorrect Message 380
Obstruction of Flow 359
High Readings 348
Signal Artifact/Noise 320
Temperature Problem 264
Coagulation in Device or Device Ingredient 259
Break 244
Device Contamination with Body Fluid 234
Device Contamination with Chemical or Other Material 216
Positioning Problem 208
Appropriate Device Problem Term/Code Not Available 206
Insufficient Cooling 202

Yearly Trend

92
1992: 1
95
1995: 6
96
1996: 6
97
1997: 15
98
1998: 5
99
1999: 1
00
2000: 3
01
2001: 10
02
2002: 18
03
2003: 20
04
2004: 61
05
2005: 56
06
2006: 83
07
2007: 61
08
2008: 75
09
2009: 76
10
2010: 63
11
2011: 102
12
2012: 248
13
2013: 406
14
2014: 799
15
2015: 1,189
16
2016: 1,010
17
2017: 1,115
18
2018: 975
19
2019: 1,124
20
2020: 1,182
21
2021: 1,240
22
2022: 1,336
23
2023: 1,500
24
2024: 1,839
25
2025: 1,199
26
2026: 618

Reports in 2025 (1,199) held close to the prior two-year average of 1,670.

Related Entities for Cardiac Ablation Percutaneous Catheter

Top Manufacturers

BIOSENSE WEBSTER INC 9,346
BIOSENSE WEBSTER, INC. (JUAREZ) 2,828
BIOSENSE WEBSTER INC. 920
BOSTON SCIENTIFIC CORPORATION 464
MEDTRONIC CRYOCATH LP 399
BIOSENSE WEBSTER, INC. 197
ST. JUDE MEDICAL, INC. 118

Event Locations

8,922 (54.3%)
I 6,760 (41.1%)
HOSPITAL 615 (3.7%)
OTHER 87 (0.5%)
NO INFORMATION 31 (0.2%)
INVALID DATA 14 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
UNKNOWN 3 (0.0%)
NOT APPLICABLE 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
HOME 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare BIOSENSE WEBSTER INC vs BIOSENSE WEBSTER, INC. (JUAREZ) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cardiac Ablation Percutaneous 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 (16,442 here).

Prosthesis 16,505 Applier, Surgical, Clip 16,547 Prosthesis 16,332 Endoscopic Ultrasound System 16,331

Similar death-typed counts

Nearest other device types by death-typed report count (724 here), distinct from the volume row.

Stimulator 729 Device, Hemostasis, Vascular 741 Stent, Carotid 695 System 777

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

Disclaimer: MAUDE figures for Cardiac Ablation Percutaneous 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 Cardiac Ablation Percutaneous 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.