Devices › Catheter, continuous flush
Device brand name · Catheter continuous flush
AngioJet SOLENT Proxi: medical device reports filed with FDA
175 reports name it, 2015–2026. Manufacturer given most often on reports: Boston Scientific - Maple Grove. Product code KRA.
- 175
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 5
- reports, 12 months to August 2026
- 4 in the 12 months before
- 84.6%
- classified as malfunction
- 74.2% across the product code
- 4.6%
- classified as death, as reported
- 8 reports · not verified by FDA
FDA's MAUDE database holds 175 reports that name the brand "AngioJet SOLENT Proxi" (catheter continuous flush), received between May 2015 and June 2026; the manufacturer given most often on reports is Boston Scientific - Maple Grove. Spellings of one product vary from report to report.
5 reports arrived in the 12 months to August 2026, up 25% from 4 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 (84.6%), injury (10.3%) and death (4.6%); across all catheter, continuous flush reports (product code KRA) death is recorded in 4% and malfunction in 74.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are aspiration issue (45.7%), device displays incorrect message (37.1%) and device operates differently than expected (2.9%). The patient problems coded most often are death, embolism and bradycardia. 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 9,056 reports carrying product code KRA. 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 |
|---|---|---|---|
| Aspiration issue | 80 | 45.7% | 0.9% |
| Device displays incorrect message | 65 | 37.1% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.9% | 0.3% |
| Hole in material | 5 | 2.9% | 0.8% |
| Failure to prime | 3 | 1.7% | 0% |
| Leak/splashthe device leaked | 3 | 1.7% | 5.3% |
| Suction problem | 3 | 1.7% | 0.1% |
| Breakthe device broke | 2 | 1.1% | 16.6% |
| Fluid/blood leak | 2 | 1.1% | 1.7% |
| Kinkedthe tube or line kinked | 2 | 1.1% | 0.8% |
| Device packaging compromised | 1 | 0.6% | 0% |
| Device stops intermittentlythe device stopped now and then | 1 | 0.6% | 0% |
| Entrapment of device | 1 | 0.6% | 2.3% |
| Material perforation | 1 | 0.6% | 0.8% |
| Torn material | 1 | 0.6% | 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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 6 | 3.4% |
| Embolism | 3 | 1.7% |
| Bradycardiaslow heart rate | 2 | 1.1% |
| Hemolysis | 2 | 1.1% |
| Multiple organ dysfunction syndromeseveral organs failing | 2 | 1.1% |
| Nauseafeeling sick | 2 | 1.1% |
| Abdominal painstomach or belly pain | 1 | 0.6% |
| Blood loss | 1 | 0.6% |
| Cardiopulmonary arrest | 1 | 0.6% |
| Disseminated intravascular coagulation (dic) | 1 | 0.6% |
| Dyspneashortness of breath | 1 | 0.6% |
| Headachehead pain | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| High blood pressure/ hypertension | 1 | 0.6% |
| Inflammationinflammation | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AngioJet SOLENT Proxi | Product code KRA | All MAUDE reports |
|---|---|---|---|
| Reports | 175 | 9,056 | 26,136,888 |
| Share of that pool | — | 1.9% | 0% |
| Classified as death, per 1,000 reports | 46 | 40 | 9 |
| Classified as injury | 10.3% | 20.9% | 36.2% |
| Classified as malfunction | 84.6% | 74.2% | 62.3% |
| Filed by the manufacturer | 96.6% | 97.1% | 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 KRA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Echelon | 1,352 | 584 | 3.2% |
| Marathon | 506 | 66 | 5.9% |
| Rebar | 457 | 108 | 9% |
| Prowler Select Microcatheters | 452 | 0 | 1.5% |
| Cxi Support Catheter | 408 | 23 | 0% |
| Marksman | 405 | 77 | 6.7% |
| Prowler Select Plus 150/5cm | 402 | 1 | 0.2% |
| Cathera | 342 | 0 | 7.3% |
| Renegade? HI-FLO? Kit | 266 | 15 | 0% |
| Prowler Select | 744 | 461 | 0.1% |
| Direxion? | 151 | 23 | 0% |
| Marathon Micro Catheter | 299 | 0 | 2.3% |
| Renegade? HI-FLO? FATHOM? System | 150 | 11 | 0% |
| AngioJet SOLENT omni | 671 | 26 | 1.3% |
| Angiojet Zelantedvt | 304 | 0 | 5.3% |
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 AngioJet SOLENT Proxi reports
How many FDA reports name AngioJet SOLENT Proxi?
175 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
malfunction (84.6%), injury (10.3%) and death (4.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
aspiration issue (45.7%), device displays incorrect message (37.1%), device operates differently than expected (2.9%), hole in material (2.9%) and failure to prime (1.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that AngioJet SOLENT Proxi 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.