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2026 data FDA MAUDE openFDA

Catheters, Transluminal Coronary Angioplasty, Percutaneous

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.

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FDA MAUDE casebook

openFDA event book Catheters MID-BOOK · MAUDE

#76 of 1000 · 42,925 reports · 1992–2026

  • BOOK 42,925 reports
  • RANK #76 of 1000
  • DEATH 578 death-typed
  • INJ 5,554 injury-typed
  • MALF 36,696 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 2,753
  • PHOTO Powered Laser Surgica…

Nearest event-volume peer: Powered Laser Surgical Instrument (195 report gap)

Catheters, Transluminal Coronary Angioplasty, Percutaneous sits #76 of 1000 among tracked device types with 42,925 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 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 12.9% corpus 30.4% · below corpus mean (-17.5 pp)
  • MALF 85.5% corpus 64.5% · above corpus mean (+21.0 pp)

Lead product-problem code Material Rupture is 38% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 23% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Catheters in the event-volume neighbourhood

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

reports

What this shows Catheters, Transluminal Coronary Angioplasty, Percutaneous carries 42,925 MAUDE reports, ranked #76 of 1000.

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

Event Types

Malfunction 36,696 (85.5%)
Injury 5,554 (12.9%)
Death 578 (1.3%)
58 (0.1%)
Other 39 (0.1%)

Patient Outcomes

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

36,432 (82.8%)
Required Intervention 3,763 (8.6%)
Other 1,394 (3.2%)
R 698 (1.6%)
Death 571 (1.3%)
Hospitalization 535 (1.2%)
Life Threatening 132 (0.3%)
O 108 (0.2%)
L 102 (0.2%)
S 93 (0.2%)
H 83 (0.2%)
Disability 68 (0.2%)
D 19 (0.0%)
Congenital Anomaly 3 (0.0%)
Invalid Data 3 (0.0%)

Top Product Problems

Material Rupture 10,318
Difficult to Remove 2,461
Break 1,935
Failure to Advance 1,375
Difficult to Advance 1,311
Adverse Event Without Identified Device or Use Problem 1,238
Deflation Problem 1,194
Improper or Incorrect Procedure or Method 1,145
Inflation Problem 992
Material Separation 940
Detachment Of Device Component 642
Burst Container or Vessel 641
Leak/Splash 573
Detachment of Device or Device Component 486
Material Deformation 458
Entrapment of Device 400
Physical Resistance 302
Deformation Due to Compressive Stress 205
Kinked 205
Failure to Deflate 175

Yearly Trend

92
1992: 2
93
1993: 4
94
1994: 36
95
1995: 34
96
1996: 261
97
1997: 490
98
1998: 432
99
1999: 224
00
2000: 334
01
2001: 436
02
2002: 651
03
2003: 724
04
2004: 615
05
2005: 873
06
2006: 1,076
07
2007: 1,053
08
2008: 1,063
09
2009: 1,353
10
2010: 1,392
11
2011: 2,090
12
2012: 2,092
13
2013: 2,436
14
2014: 2,316
15
2015: 2,060
16
2016: 2,577
17
2017: 2,753
18
2018: 2,225
19
2019: 2,102
20
2020: 1,974
21
2021: 1,738
22
2022: 1,816
23
2023: 1,720
24
2024: 1,804
25
2025: 1,922
26
2026: 247

Related Entities for Catheters, Transluminal Coronary Angioplasty, Percutaneous

Top Manufacturers

AV-TEMECULA-CT 8,562
BOSTON SCIENTIFIC CORPORATION 8,507
BOSTON SCIENTIFIC - MAPLE GROVE 7,804
BOSTON SCIENTIFIC 4,399
ABBOTT VASCULAR 2,967
MEDTRONIC MEXICO 1,730
BOSTON SCIENTIFIC - GALWAY 1,333
ABBOTT VASCULAR INC. 927
GUIDANT VASCULAR INTERVENTION 608
ABBOTT VASCULAR-CARDIAC THERAPIES 589

Event Locations

25,215 (58.7%)
I 13,714 (31.9%)
HOSPITAL 2,133 (5.0%)
UNKNOWN 721 (1.7%)
OTHER 659 (1.5%)
NOT APPLICABLE 265 (0.6%)
NO INFORMATION 131 (0.3%)
INVALID DATA 80 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
HOME 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare AV-TEMECULA-CT vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheters, 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 (42,925 here).

Powered Laser Surgical Instrument 42,730 Dialyzer 42,530 Neurological Stereotaxic Instrument 42,097 Stimulator, Spinal-Cord, Implanted 43,829

Similar death-typed counts

Nearest other device types by death-typed report count (578 here), distinct from the volume row.

Monitor, Cardiac 575 Intracranial Aneurysm Flow Diverter 600 Tubes, Gastrointestinal 620 Intracranial Neurovascular Stent 533

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

Disclaimer: MAUDE figures for Catheters 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 Catheters; 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.