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2026 data FDA MAUDE openFDA

Catheter, Nephrostomy

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, Nephrostomy LIGHT-BOOK · MAUDE

#724 of 1000 · 812 reports · 1992–2026

  • BOOK 812 reports
  • RANK #724 of 1000
  • DEATH 8 death-typed
  • INJ 259 injury-typed
  • MALF 536 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 131
  • PHOTO Applicator

Nearest event-volume peer: Applicator, Absorbent Tipped, Sterile (1 report gap)

Catheter, Nephrostomy sits #724 of 1000 among tracked device types with 812 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

Catheter, Nephrostomy carries 31.9% INJURY-coded reports, 1.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
  • INJ 31.9% corpus 30.3% · above corpus mean (+1.6 pp)
  • MALF 66.0% corpus 64.8% · above corpus mean (+1.2 pp)

Lead product-problem code Burst Container or Vessel is 13% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 32% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Catheter, Nephrostomy in the event-volume neighbourhood

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

reports

What this shows Catheter, Nephrostomy carries 812 MAUDE reports, ranked #724 of 1000.

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

Event Types

Malfunction 536 (66.0%)
Injury 259 (31.9%)
Death 8 (1.0%)
Other 6 (0.7%)
3 (0.4%)

Patient Outcomes

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

467 (54.1%)
Required Intervention 185 (21.4%)
Other 111 (12.9%)
Hospitalization 38 (4.4%)
R 29 (3.4%)
H 15 (1.7%)
Death 7 (0.8%)
O 4 (0.5%)
S 2 (0.2%)
Life Threatening 2 (0.2%)
D 1 (0.1%)
L 1 (0.1%)
Invalid Data 1 (0.1%)

Top Product Problems

Burst Container or Vessel 93
Break 83
Adverse Event Without Identified Device or Use Problem 69
Material Rupture 63
Fluid/Blood Leak 51
Difficult to Remove 48
Fracture 38
Leak/Splash 38
Detachment of Device or Device Component 32
Material Separation 32
Device, or device fragments remain in patient 28
Difficult to Advance 22
Material Deformation 20
Device Contamination with Chemical or Other Material 19
Inflation Problem 18
Replace 18
Material Puncture/Hole 17
Material Fragmentation 15
Material Split, Cut or Torn 14
Nonstandard Device 14

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 1
95
1995: 7
96
1996: 7
97
1997: 18
98
1998: 12
99
1999: 11
00
2000: 3
01
2001: 3
02
2002: 5
03
2003: 5
05
2005: 5
06
2006: 5
07
2007: 5
08
2008: 8
09
2009: 12
10
2010: 6
11
2011: 15
12
2012: 16
13
2013: 15
14
2014: 4
15
2015: 9
16
2016: 26
17
2017: 60
18
2018: 69
19
2019: 78
20
2020: 50
21
2021: 38
22
2022: 42
23
2023: 131
24
2024: 47
25
2025: 61
26
2026: 34

Reports in 2025 (61) held close to the prior two-year average of 89.

Related Entities for Catheter, Nephrostomy

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 209
COOK INC 161
C.R. BARD, INC. (COVINGTON) -1018233 85
BOSTON SCIENTIFIC - GALWAY 75
COLOPLAST A/S 71
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 19
BOSTON SCIENTIFIC 18
BOSTON SCIENTIFIC CORP. 11
C.R. BARD INC. (COVINGTON) -1018233 11

Event Locations

389 (47.9%)
I 295 (36.3%)
HOSPITAL 109 (13.4%)
NO INFORMATION 9 (1.1%)
INVALID DATA 3 (0.4%)
OUTPATIENT TREATMENT FACILITY 2 (0.2%)
UNKNOWN 2 (0.2%)
HOME 1 (0.1%)
NURSING HOME 1 (0.1%)
OTHER 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs COOK INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Nephrostomy: 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 (812 here).

Applicator, Absorbent Tipped, Sterile 813 Lithotriptor 811 Respiratory Virus Panel Nucleic Acid Assay… 808 Unit, Neonatal Phototherapy 808

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, Balloon, Transcervical 8 Container 8

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

Disclaimer: MAUDE figures for Catheter, Nephrostomy 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, Nephrostomy; 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.