Devices › Catheter, intravascular, diagnostic
Device brand name · Catheter intravascular diagnostic
Dragonfly OpStar: medical device reports filed with FDA
187 reports name it, 2020–2026. Manufacturer given most often on reports: Lightlab Imaging. Product code DQO.
- 187
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 88
- reports, 12 months to August 2026
- 60 in the 12 months before
- 83.4%
- classified as malfunction
- 56% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 187 reports that name the brand "Dragonfly OpStar" (catheter intravascular diagnostic), received between April 2020 and August 2026; the manufacturer given most often on reports is Lightlab Imaging. Spellings of one product vary from report to report.
88 reports arrived in the 12 months to August 2026, up 47% from 60 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 (83.4%), injury (16%) and death (0.5%); across all catheter, intravascular, diagnostic reports (product code DQO) death is recorded in 2.2% and malfunction in 56%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to remove (46.5%), material split, cut or torn (17.1%) and material separation (13.9%). The patient problems coded most often are vascular dissection, obstruction/occlusion and non specific ekg/ECG changes. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 20,198 reports carrying product code DQO. 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 |
|---|---|---|---|
| Difficult to removethe device was hard to remove | 87 | 46.5% | 8.7% |
| Material split, cut or torn | 32 | 17.1% | 0.5% |
| Material separation | 26 | 13.9% | 9.8% |
| Difficult to advance | 21 | 11.2% | 0.7% |
| Deformation due to compressive stress | 19 | 10.2% | 0.2% |
| Breakthe device broke | 18 | 9.6% | 13.8% |
| Communication or transmission problemthe device could not communicate or transmit | 13 | 7% | 0.2% |
| No display/image | 13 | 7% | 0.3% |
| Improper or incorrect procedure or method | 12 | 6.4% | 0.2% |
| Failure to advance | 9 | 4.8% | 1% |
| Fluid/blood leak | 8 | 4.3% | 2.5% |
| Poor quality image | 7 | 3.7% | 0.1% |
| Air/gas in device | 4 | 2.1% | 0.1% |
| Entrapment of device | 4 | 2.1% | 1.5% |
| Activation failure | 3 | 1.6% | 0% |
| Gas/air leak | 3 | 1.6% | 0.1% |
| Material rupture | 3 | 1.6% | 1.1% |
| Material too soft/flexible | 3 | 1.6% | 0% |
| Stretched | 3 | 1.6% | 0.4% |
| Activation, positioning or separation problem | 2 | 1.1% | 0.1% |
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 |
|---|---|---|
| Vascular dissection | 12 | 6.4% |
| Obstruction/occlusion | 6 | 3.2% |
| Non specific ekg/ECG changes | 4 | 2.1% |
| Vasoconstriction | 3 | 1.6% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 3 | 1.6% |
| Air embolism | 2 | 1.1% |
| Angina | 2 | 1.1% |
| Bradycardiaslow heart rate | 2 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 1.1% |
| Cardiac arrestthe heart stopped | 1 | 0.5% |
| Cardiac enzyme elevation | 1 | 0.5% |
| Device embedded in tissue or plaque | 1 | 0.5% |
| Ischemia | 1 | 0.5% |
| Low blood pressure/ hypotension | 1 | 0.5% |
| Myocardial infarctionheart attack | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dragonfly OpStar | Product code DQO | All MAUDE reports |
|---|---|---|---|
| Reports | 187 | 20,198 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 5 | 22 | 9 |
| Classified as injury | 16% | 37.6% | 36.2% |
| Classified as malfunction | 83.4% | 56% | 62.3% |
| Filed by the manufacturer | 97.3% | 82.1% | 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 DQO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Merit Custom Kit | 1,590 | 13 | 0.1% |
| Ultrasonic Imaging Catheter - Coronary | 569 | 0 | 0% |
| Trapease Pvcf Fem/Jug 55cm Csi | 983 | 0 | 3.7% |
| 466p306x | 717 | 0 | 1.8% |
| Renegade | 301 | 0 | 0.3% |
| Infiniti | 267 | 141 | 0% |
| Tempo | 721 | 155 | 0.7% |
| Impress Braided Catheter | 215 | 0 | 0% |
| Impress | 200 | 25 | 1% |
| Impress Peripheral Catheter | 186 | 0 | 0% |
| V-Cath | 175 | 0 | 1.7% |
| Arrow | 830 | 65 | 3.4% |
| Bard | 1,124 | 2 | 1.8% |
| Trapease Filter | 165 | 0 | 13.9% |
| Guide Wires | 374 | 0 | 1.6% |
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 Dragonfly OpStar reports
How many FDA reports name Dragonfly OpStar?
187 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 88 in the latest 12 months.
What kinds of events are reported?
malfunction (83.4%), injury (16%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (46.5%), material split, cut or torn (17.1%), material separation (13.9%), difficult to advance (11.2%) and deformation due to compressive stress (10.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Dragonfly OpStar 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.