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2026 data FDA MAUDE openFDA FDA Class II

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.1252 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Percutaneous Catheter For Creation Of An Ar… LIGHT-BOOK · MAUDE

#903 of 1000 · 486 reports · 2018–2026

  • BOOK 486 reports
  • RANK #903 of 1000
  • DEATH 7 death-typed
  • INJ 211 injury-typed
  • MALF 268 malfunction
  • SPAN 2018–2026
  • PEAK 2024: 78
  • PHOTO Cane

Nearest event-volume peer: Cane (2 report gap)

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access sits #903 of 1000 among tracked device types with 486 MAUDE reports spanning 2018–2026. 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

Percutaneous Catheter For Creation Of An Ar… carries 43.4% INJURY-coded reports, 13.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 43.4% corpus 30.3% · above corpus mean (+13.1 pp)
  • MALF 55.1% corpus 64.8% · below corpus mean (-9.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 96% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Percutaneous Catheter For Creation Of An Ar… in the event-volume neighbourhood

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

reports

What this shows Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access carries 486 MAUDE reports, ranked #903 of 1000.

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

Event Types

Malfunction 268 (55.1%)
Injury 211 (43.4%)
Death 7 (1.4%)

Patient Outcomes

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

232 (46.5%)
Required Intervention 173 (34.7%)
Other 60 (12.0%)
R 11 (2.2%)
Death 8 (1.6%)
O 6 (1.2%)
Hospitalization 4 (0.8%)
Life Threatening 4 (0.8%)
S 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 202
Material Deformation 105
Failure to Cut 81
Failure to Align 47
Activation Problem 38
Break 32
Device Dislodged or Dislocated 23
Difficult to Remove 16
Difficult to Advance 10
Device-Device Incompatibility 9
Activation, Positioning or Separation Problem 8
Mechanical Jam 8
Device Damaged Prior to Use 7
Stretched 6
Improper or Incorrect Procedure or Method 5
Material Twisted/Bent 5
Insufficient Device Problem Information 4
Physical Resistance/Sticking 3
Positioning Problem 3
Restricted Flow rate 3

Yearly Trend

18
2018: 3
19
2019: 51
20
2020: 61
21
2021: 74
22
2022: 77
23
2023: 71
24
2024: 78
25
2025: 44
26
2026: 27

Reports fell to 44 in 2025, down from an average of 75 in the two years before.

Related Entities for Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Top Manufacturers

BARD PERIPHERAL VASCULAR, INC. 80
UNK 2
UNKNOWN 1

Event Locations

329 (67.7%)
I 155 (31.9%)
HOSPITAL 1 (0.2%)
NO INFORMATION 1 (0.2%)

Compare BARD PERIPHERAL VASCULAR, INC. vs UNK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Percutaneous Catheter For Creation Of An Ar…: 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 (486 here).

Cane 484 Patient Examination Glove 484 Joint, Knee, External Brace 489 Reservoir, Blood, Cardiopulmonary Bypass 490

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

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

Disclaimer: MAUDE figures for Percutaneous Catheter For Creation Of An Ar… 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 Percutaneous Catheter For Creation Of An Ar…; 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.