2026 data FDA MAUDE openFDA

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.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Cardiac Ablation Percutaneous Catheter MID-BOOK · MAUDE

#162 of 1000 · 15,997 reports · 1992–2026

  • BOOK 15,997 reports
  • RANK #162 of 1000
  • DEATH 710 death-typed
  • INJ 9,395 injury-typed
  • MALF 5,824 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 1,839
  • PHOTO Fastener

Nearest event-volume peer: Fastener, Fixation, Biodegradable, Soft Tissue (43 report gap)

Cardiac Ablation Percutaneous Catheter sits #162 of 1000 among tracked device types with 15,997 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 →

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 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 58.7% corpus 30.4% · above corpus mean (+28.3 pp)
  • MALF 36.4% corpus 64.5% · below corpus mean (-28.1 pp)

Lead product-problem code Patient Device Interaction Problem is 30% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 65% of manufacturer-tagged reports · Top event location is 53% 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 15,997 MAUDE reports, ranked #162 of 1000.

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

Event Types

Injury 9,395 (58.7%)
Malfunction 5,824 (36.4%)
Death 710 (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.

5,757 (22.0%)
R 5,695 (21.8%)
Life Threatening 3,800 (14.6%)
L 3,234 (12.4%)
Hospitalization 2,927 (11.2%)
Required Intervention 1,619 (6.2%)
Other 1,255 (4.8%)
H 890 (3.4%)
Death 618 (2.4%)
O 150 (0.6%)
D 110 (0.4%)
S 54 (0.2%)
Disability 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Patient Device Interaction Problem 3,729
Adverse Event Without Identified Device or Use Problem 3,501
Material Puncture/Hole 673
Incorrect, Inadequate or Imprecise Result or Readings 545
Contamination /Decontamination Problem 438
Insufficient Information 437
Failure to Sense 406
High Readings 343
Obstruction of Flow 314
Coagulation in Device or Device Ingredient 253
Signal Artifact/Noise 250
Device Contamination with Body Fluid 214
Temperature Problem 184
Insufficient Cooling 179
Device Operates Differently Than Expected 178
Appropriate Term/Code Not Available 163
Device Contamination with Chemical or Other Material 156
Positioning Problem 147
Device Displays Incorrect Message 144
Communication or Transmission Problem 133

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: 173

Related Entities for Cardiac Ablation Percutaneous Catheter

Event Locations

8,491 (53.1%)
I 6,760 (42.3%)
HOSPITAL 602 (3.8%)
OTHER 86 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Cardiac Ablation Percutaneous Catheter, 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 (15,997 here).

Similar death-typed counts

Nearest other device types by death-typed report count (710 here), distinct from the volume row.

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.