Devices › Temporary carotid catheter for embolic capture
Device brand name · Embolic protection system
Rx Accunet Embolic Protection System: medical device reports filed with FDA
429 reports name it, 2004–2015. Manufacturer given most often on reports: Guidant Endovascular Solutions. Product code NTE.
- 429
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 14%
- classified as malfunction
- 34.8% across the product code
- 2.1%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 429 reports that name the brand "Rx Accunet Embolic Protection System" (embolic protection system), received between October 2004 and December 2015; the manufacturer given most often on reports is Guidant Endovascular Solutions. 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 (83.9%), malfunction (14%) and death (2.1%); across all temporary carotid catheter for embolic capture reports (product code NTE) death is recorded in 2.1% and malfunction in 34.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to remove (34.5%), physical resistance (19.3%) and failure to advance (8.2%). The patient problems coded most often are therapy/non-surgical treatment, additional, foreign body, removal of and hospitalization required. 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 Rx Accunet Embolic Protection System was received in the five years to August 2026; the latest was received in December 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,335 reports carrying product code NTE. 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 | 148 | 34.5% | 15.6% |
| Physical resistance | 83 | 19.3% | 3.7% |
| Failure to advance | 35 | 8.2% | 1.8% |
| Source, detachment from | 34 | 7.9% | 0.5% |
| Detachment of device component | 28 | 6.5% | 3.1% |
| Replace | 26 | 6.1% | 0.5% |
| Sticking | 24 | 5.6% | 0.4% |
| Device, removal of (non-implant) | 20 | 4.7% | 0.6% |
| Breakthe device broke | 18 | 4.2% | 4.1% |
| Difficult to position | 16 | 3.7% | 0.9% |
| Device remains implanted | 13 | 3% | 0.3% |
| Difficult to insertthe device was hard to insert | 13 | 3% | 3.4% |
| Kinkedthe tube or line kinked | 13 | 3% | 1.3% |
| Material separation | 13 | 3% | 5.4% |
| Migration or expulsion of device | 13 | 3% | 2.2% |
| Device damaged by another device | 8 | 1.9% | 0.9% |
| Improper or incorrect procedure or method | 7 | 1.6% | 5.7% |
| Stretched | 7 | 1.6% | 2.8% |
| Device, or device fragments remain in patient | 6 | 1.4% | 0.2% |
| Device difficult to setup or prepare | 5 | 1.2% | 0.4% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 134 | 31.2% |
| Foreign body, removal of | 104 | 24.2% |
| Hospitalization required | 75 | 17.5% |
| Stroke | 60 | 14% |
| Treatment with medication(s) | 43 | 10% |
| Neurological deficit/dysfunction | 31 | 7.2% |
| Embolism | 27 | 6.3% |
| Surgical procedure | 27 | 6.3% |
| Stroke/cva | 25 | 5.8% |
| Low blood pressure/ hypotension | 19 | 4.4% |
| No patient involvement | 17 | 4% |
| Weakness | 17 | 4% |
| Other (for use when an appropriate patient code cannot be identified) | 16 | 3.7% |
| Transient ischemic attack | 14 | 3.3% |
| Disability | 13 | 3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Rx Accunet Embolic Protection System | Product code NTE | All MAUDE reports |
|---|---|---|---|
| Reports | 429 | 5,335 | 26,136,888 |
| Share of that pool | — | 8% | 0% |
| Classified as death, per 1,000 reports | 21 | 21 | 9 |
| Classified as injury | 83.9% | 62.7% | 36.2% |
| Classified as malfunction | 14% | 34.8% | 62.3% |
| Filed by the manufacturer | 100% | 98.1% | 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 NTE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Emboshield Nav6 Embolic Protection System | 1,004 | 0 | 1.7% |
| ENROUTE Transcarotid Neuroprotection System | 660 | 130 | 2% |
| Spider Fx | 649 | 65 | 2% |
| Angioguard Rx | 367 | 38 | 0.5% |
| Enroute Neuroprotection System | 331 | 0 | 0.6% |
| Angioguard Rx Emboli Capture Guidewire System | 317 | 0 | 0.6% |
| Angioguard Xp Emboli Capture Guidewire System | 275 | 0 | 0% |
| Emboshield Nav6 | 252 | 90 | 0.8% |
| Spiderfx Embolic Protection Device | 232 | 0 | 6% |
| FilterWire EZ | 507 | 71 | 0.4% |
| Filterwire Ez Emoblic Protection System | 164 | 0 | 1.8% |
| Abbott | 265 | 0 | 7.5% |
| Nanocross 0 14 Otw Pta Dilatation Catheter | 211 | 22 | 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 Rx Accunet Embolic Protection System reports
How many FDA reports name Rx Accunet Embolic Protection System?
429 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 (83.9%), malfunction (14%) and death (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (34.5%), physical resistance (19.3%), failure to advance (8.2%), source, detachment from (7.9%) and detachment of device component (6.5%). 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 Rx Accunet Embolic Protection System 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.