Reported Reactions

Devices › Catheter, percutaneous

Device brand name · Dqy

Velocity Delivery Microcatheter: medical device reports filed with FDA

336 reports name it, 2013–2026. Manufacturer given most often on reports: Penumbra. Product code DQY.

336
device reports naming the brand
0% of all MAUDE reports · about 25 a year
21
reports, 12 months to August 2026
14 in the 12 months before
91.4%
classified as malfunction
74.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

336 medical device reports received by FDA name the brand "Velocity Delivery Microcatheter" (dqy); the manufacturer given most often on reports is Penumbra; received from January 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

21 reports arrived in the 12 months to August 2026, up 50% from 14 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 (91.4%) and injury (8.6%); 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 break (43.2%), fracture (21.7%) and physical resistance/sticking (16.4%). The patient problems coded most often are no patient involvement, foreign body in patient and hemorrhage, subarachnoid. 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

059Sep 2021: 3Oct 2021: 3Nov 2021: 5Dec 2021: 22022Jan 2022: 0Feb 2022: 2Mar 2022: 0Apr 2022: 1May 2022: 0Jun 2022: 3Jul 2022: 2Aug 2022: 4Sep 2022: 4Oct 2022: 5Nov 2022: 2Dec 2022: 52023Jan 2023: 6Feb 2023: 7Mar 2023: 8Apr 2023: 9May 2023: 2Jun 2023: 5Jul 2023: 6Aug 2023: 3Sep 2023: 1Oct 2023: 3Nov 2023: 2Dec 2023: 12024Jan 2024: 0Feb 2024: 0Mar 2024: 1Apr 2024: 5May 2024: 2Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 2Feb 2025: 3Mar 2025: 3Apr 2025: 1May 2025: 0Jun 2025: 3Jul 2025: 2Aug 2025: 0Sep 2025: 1Oct 2025: 2Nov 2025: 1Dec 2025: 02026Jan 2026: 1Feb 2026: 0Mar 2026: 6Apr 2026: 1May 2026: 1Jun 2026: 2Jul 2026: 1Aug 2026: 5

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

027532013: 520132014: 92015: 2120152016: 252017: 1920172018: 332019: 3020192020: 292021: 4120212022: 282023: 5320232024: 82025: 1820252026: 17

Event type and report source

Event type, as classified on the report

Death0%0
Injury8.6%29
Malfunction91.4%307
Other0%0
Not given0%0

Who filed the report

Manufacturer report95.8%322
Voluntary report1.8%6
User facility report0%0
Distributor report0%0
Not given2.4%8

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)ReportsShareShare across product code
Breakthe device broke14543.2%9.2%
Fracturea broken bone7321.7%2.6%
Physical resistance/sticking5516.4%2.9%
Device damaged prior to usethe device was damaged before use4312.8%1.8%
Out-of-box failure267.7%0.7%
Kinkedthe tube or line kinked216.3%3.4%
Stretched154.5%0.5%
Material deformation133.9%5%
Failure to advance92.7%2.6%
Unraveled material92.7%2.1%
Difficult to advance82.4%1.8%
Physical resistance61.8%1.3%
Crackthe device cracked51.5%1.8%
Device operates differently than expectedthe device behaved unexpectedly30.9%0.7%
Insufficient device problem information30.9%0.9%
Bent20.6%0.4%
Device operational issue20.6%0%
Material fragmentation20.6%0.4%
Material puncture/hole20.6%0.6%
Material separation20.6%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)ReportsShare
No patient involvement5014.9%
Foreign body in patientpart of a device left in the patient30.9%
Hemorrhage, subarachnoid30.9%
Anemialow red blood cells20.6%
Device embedded in tissue or plaque20.6%
Granuloma20.6%
Hemorrhage, cerebral20.6%
Infarction, cerebral20.6%
Intracranial hemorrhage20.6%
Perforation of vessels20.6%
Vascular dissection20.6%
Appropriate clinical signs, symptoms and conditions term/code not available10.3%
Atrial fibrillationan irregular heart rhythm10.3%
Embolism10.3%
Extravasation10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureVelocity Delivery MicrocatheterProduct code DQYAll MAUDE reports
Reports33641,79326,136,888
Share of that pool—0.8%0%
Classified as death, per 1,000 reports0229
Classified as injury8.6%22.7%36.2%
Classified as malfunction91.4%74.7%62.3%
Filed by the manufacturer95.8%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

BrandReportsLatest 12 monthsClassified as death
Sterling4,9633000.1%
Deflect1,0212470.1%
Guidezilla1,01800%
Lantern Delivery Microcatheter887190%
WATCHMAN FXD Curve Access System9731989.6%
Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm1,4061700.1%
Coyote?1,7671220.1%
Advance 35 Lp Low Profile Balloon Catheter572150.5%
Conquest Pta Dilatation Catheter50500.2%
WATCHMAN TruSeal Access System716508%
Sterling Balloon Dilatation Catheter48800.4%
React catheter5164118.4%
Conquest Pta Balloon Dilatation Catheter51000.2%
Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm1,1101230.1%
Neuron Max 6f 088 Long Sheath38900.5%

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 Velocity Delivery Microcatheter reports

How many FDA reports name Velocity Delivery Microcatheter?

336 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 21 in the latest 12 months.

What kinds of events are reported?

malfunction (91.4%) and injury (8.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (43.2%), fracture (21.7%), physical resistance/sticking (16.4%), device damaged prior to use (12.8%) and out-of-box failure (7.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (95.8%) and voluntary reports (1.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Velocity Delivery Microcatheter 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.