Devices › Catheter, percutaneous
Device brand name · Percutaneous catheter
Neuron Delivery Catheter 070: medical device reports filed with FDA
293 reports name it, 2009–2020. Manufacturer given most often on reports: Penumbra. Product code DQY.
- 293
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.6%
- classified as malfunction
- 74.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
293 medical device reports received by FDA name the brand "Neuron Delivery Catheter 070" (percutaneous catheter); the manufacturer given most often on reports is Penumbra; received from January 2009 to September 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (97.6%), injury (1.7%) and other (0.7%); across all catheter, percutaneous reports (product code DQY) death is recorded in 2.2% and malfunction in 74.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are kinked (36.2%), device damaged prior to use (15.4%) and break (12.3%). The patient problems coded most often are no patient involvement, intimal dissection and occlusion. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Neuron Delivery Catheter 070 was received in the five years to August 2026; the latest was received in September 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 41,793 reports carrying product code DQY. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Kinkedthe tube or line kinked | 106 | 36.2% | 3.4% |
| Device damaged prior to usethe device was damaged before use | 45 | 15.4% | 1.8% |
| Breakthe device broke | 36 | 12.3% | 9.2% |
| Out-of-box failure | 34 | 11.6% | 0.7% |
| Nonstandard device | 29 | 9.9% | 0.2% |
| Collapse | 21 | 7.2% | 0.2% |
| Failure to advance | 21 | 7.2% | 2.6% |
| Material deformation | 13 | 4.4% | 5% |
| Physical resistance | 13 | 4.4% | 1.3% |
| Device damaged prior to receipt by user | 11 | 3.8% | 0.1% |
| Difficult to advance | 11 | 3.8% | 1.8% |
| Deformation due to compressive stress | 8 | 2.7% | 2.3% |
| Fluid/blood leak | 8 | 2.7% | 2.1% |
| Crackthe device cracked | 7 | 2.4% | 1.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 2.4% | 0.7% |
| Fracturea broken bone | 7 | 2.4% | 2.6% |
| Difficult to insertthe device was hard to insert | 5 | 1.7% | 1.2% |
| Sticking | 5 | 1.7% | 0.5% |
| Bent | 4 | 1.4% | 0.4% |
| Difficult to removethe device was hard to remove | 4 | 1.4% | 4.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 40 | 13.7% |
| Intimal dissection | 4 | 1.4% |
| Occlusion | 2 | 0.7% |
| Vasoconstriction | 2 | 0.7% |
| Blood loss | 1 | 0.3% |
| Device embedded in tissue or plaque | 1 | 0.3% |
| Embolism | 1 | 0.3% |
| Headachehead pain | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Neuron Delivery Catheter 070 | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 293 | 41,793 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 22 | 9 |
| Classified as injury | 1.7% | 22.7% | 36.2% |
| Classified as malfunction | 97.6% | 74.7% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code DQY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sterling | 4,963 | 300 | 0.1% |
| Deflect | 1,021 | 247 | 0.1% |
| Guidezilla | 1,018 | 0 | 0% |
| Lantern Delivery Microcatheter | 887 | 19 | 0% |
| WATCHMAN FXD Curve Access System | 973 | 198 | 9.6% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Coyote? | 1,767 | 122 | 0.1% |
| Advance 35 Lp Low Profile Balloon Catheter | 572 | 15 | 0.5% |
| Conquest Pta Dilatation Catheter | 505 | 0 | 0.2% |
| WATCHMAN TruSeal Access System | 716 | 50 | 8% |
| Sterling Balloon Dilatation Catheter | 488 | 0 | 0.4% |
| React catheter | 516 | 41 | 18.4% |
| Conquest Pta Balloon Dilatation Catheter | 510 | 0 | 0.2% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Neuron Max 6f 088 Long Sheath | 389 | 0 | 0.5% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Neuron Delivery Catheter 070 reports
How many FDA reports name Neuron Delivery Catheter 070?
293 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (97.6%), injury (1.7%) and other (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
kinked (36.2%), device damaged prior to use (15.4%), break (12.3%), out-of-box failure (11.6%) and nonstandard device (9.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Neuron Delivery Catheter 070 was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.