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2016 data FDA MAUDE openFDA FDA Class III

Catheter, Balloon, Transcervical

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 Catheter, Balloon, Transcervical LIGHT-BOOK · MAUDE

#758 of 1000 · 753 reports · 1998–2016

  • BOOK 753 reports
  • RANK #758 of 1000
  • DEATH 8 death-typed
  • INJ 298 injury-typed
  • MALF 418 malfunction
  • SPAN 1998–2016
  • PEAK 2002: 133
  • PHOTO Catheter, Balloon Type

Nearest event-volume peer: Catheter, Balloon Type (2 report gap)

Catheter, Balloon, Transcervical sits #758 of 1000 among tracked device types with 753 MAUDE reports spanning 1998–2016. 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 →

Malfunction reports sit below the device-type norm

Catheter, Balloon, Transcervical carries 55.5% MALFUNCTION-coded reports, 9.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 39.6% corpus 30.3% · above corpus mean (+9.3 pp)
  • MALF 55.5% corpus 64.8% · below corpus mean (-9.3 pp)

Lead product-problem code Replace is 14% of coded problems · Lead manufacturer ETHICON, INC. accounts for 96% of manufacturer-tagged reports · Top event location HOSPITAL is 74% of location-tagged rows .

Catheter, Balloon, Transcervical in the event-volume neighbourhood

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

reports

What this shows Catheter, Balloon, Transcervical carries 753 MAUDE reports, ranked #758 of 1000.

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

Event Types

Malfunction 418 (55.5%)
Injury 298 (39.6%)
Other 20 (2.7%)
9 (1.2%)
Death 8 (1.1%)

Patient Outcomes

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

427 (51.6%)
Required Intervention 215 (26.0%)
Hospitalization 61 (7.4%)
R 53 (6.4%)
Other 37 (4.5%)
L 12 (1.5%)
Death 8 (1.0%)
Disability 5 (0.6%)
O 4 (0.5%)
H 2 (0.2%)
Life Threatening 2 (0.2%)
S 1 (0.1%)

Top Product Problems

Replace 152
Balloon leak(s) 127
Other (for use when an appropriate device code cannot be identified) 124
Unknown (for use when the device problem is not known) 107
Device Displays Incorrect Message 94
Decrease in Pressure 84
Pressure, insufficient 57
Material Perforation 46
Thermal Decomposition of Device 40
Balloon burst 36
Device Issue 27
Leak/Splash 25
Device Maintenance Issue 23
Hole In Material 22
Inflation Problem 22
Loss of Power 22
Fluid/Blood Leak 21
Overheating of Device 20
Tears, rips, holes in device, device material 18
Increase in Pressure 14

Yearly Trend

98
1998: 5
99
1999: 12
00
2000: 12
01
2001: 38
02
2002: 133
03
2003: 24
04
2004: 40
05
2005: 36
06
2006: 59
07
2007: 96
08
2008: 84
09
2009: 78
10
2010: 82
11
2011: 24
12
2012: 8
13
2013: 9
14
2014: 7
15
2015: 5
16
2016: 1

Reports fell to 5 in 2015, down from an average of 8 in the two years before.

Related Entities for Catheter, Balloon, Transcervical

Top Manufacturers

ETHICON, INC. 408
UNK 17

Event Locations

HOSPITAL 556 (73.8%)
OTHER 63 (8.4%)
52 (6.9%)
UNKNOWN 43 (5.7%)
AMBULATORY SURGICAL FACILITY 22 (2.9%)
OUTPATIENT TREATMENT FACILITY 9 (1.2%)
HOME 5 (0.7%)
INVALID DATA 1 (0.1%)
NO INFORMATION 1 (0.1%)
NURSING HOME 1 (0.1%)

Compare ETHICON, INC. vs UNK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Balloon, Transcervical: 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 (753 here).

Catheter, Balloon Type 751 Extractor, Vacuum, Fetal 751 Prosthesis 755 Mesh 756

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Nephrostomy 8 Container 8

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

Disclaimer: MAUDE figures for Catheter, Balloon, Transcervical 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 Catheter, Balloon, Transcervical; 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.