Devices › Catheter, intravascular, diagnostic
Device brand name · Thrombectomy systems dqo
Trapease Filter: medical device reports filed with FDA
165 reports name it, 2003–2016. Manufacturer given most often on reports: Cordis. Product code DQO.
- 165
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 11.5%
- classified as malfunction
- 56% across the product code
- 13.9%
- classified as death, as reported
- 23 reports · not verified by FDA
FDA's MAUDE database holds 165 reports that name the brand "Trapease Filter" (thrombectomy systems dqo), received between April 2003 and September 2016; the manufacturer given most often on reports is Cordis. Spellings of one product vary from report to report.
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 injury (73.9%), death (13.9%) and malfunction (11.5%); 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 occlusion within device (12.7%), fracture (12.1%) and difficult to remove (7.9%). The patient problems coded most often are thrombosis, death and pulmonary embolism. 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 Trapease Filter was received in the five years to August 2026; the latest was received in September 2016.
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 |
|---|---|---|---|
| Occlusion within devicethe device blocked | 21 | 12.7% | 0.9% |
| Fracturea broken bone | 20 | 12.1% | 7.8% |
| Difficult to removethe device was hard to remove | 13 | 7.9% | 8.7% |
| Unintended movement | 13 | 7.9% | 0.5% |
| Migration or expulsion of device | 10 | 6.1% | 3.1% |
| Failure to align | 8 | 4.8% | 1.2% |
| Insufficient device problem information | 6 | 3.6% | 0.2% |
| Complete blockage | 4 | 2.4% | 0.2% |
| Expulsion | 3 | 1.8% | 0% |
| Detachment of device component | 1 | 0.6% | 3.8% |
| Device issuea problem with the device | 1 | 0.6% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.6% | 0.5% |
| Difficult or delayed positioning | 1 | 0.6% | 0.2% |
| Failure to adhere or bond | 1 | 0.6% | 0% |
| Inaccurate delivery | 1 | 0.6% | 0% |
| Therapy delivered to incorrect body area | 1 | 0.6% | 0% |
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 |
|---|---|---|
| Thrombosis | 63 | 38.2% |
| Deaththe patient died; cause not stated by this term | 18 | 10.9% |
| Pulmonary embolisma blood clot in the lung | 12 | 7.3% |
| Injurya physical injury | 8 | 4.8% |
| Occlusion | 8 | 4.8% |
| Perforation | 7 | 4.2% |
| Stenosis | 6 | 3.6% |
| Embolism | 3 | 1.8% |
| Hemorrhage/blood loss/bleeding | 3 | 1.8% |
| Respiratory distressdifficulty breathing | 3 | 1.8% |
| Device embedded in tissue or plaque | 2 | 1.2% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.2% |
| Low blood pressure/ hypotension | 2 | 1.2% |
| Painpain, site not specified | 2 | 1.2% |
| Perforation of vessels | 2 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Trapease Filter | Product code DQO | All MAUDE reports |
|---|---|---|---|
| Reports | 165 | 20,198 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 139 | 22 | 9 |
| Classified as injury | 73.9% | 37.6% | 36.2% |
| Classified as malfunction | 11.5% | 56% | 62.3% |
| Filed by the manufacturer | 98.2% | 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% |
| Dragonfly OpStar | 187 | 88 | 0.5% |
| V-Cath | 175 | 0 | 1.7% |
| Arrow | 830 | 65 | 3.4% |
| Bard | 1,124 | 2 | 1.8% |
| 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 Trapease Filter reports
How many FDA reports name Trapease Filter?
165 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?
injury (73.9%), death (13.9%) and malfunction (11.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
occlusion within device (12.7%), fracture (12.1%), difficult to remove (7.9%), unintended movement (7.9%) and migration or expulsion of device (6.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.2%) and voluntary reports (1.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Trapease Filter 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.