Devices › Temporary carotid catheter for embolic capture
Device brand name · Temporary carotid catheter for embolic capture
Emboshield Nav6: medical device reports filed with FDA
252 reports name it, 2020–2026. Manufacturer given most often on reports: Abbott Vascular. Product code NTE.
- 252
- device reports naming the brand
- 0% of all MAUDE reports · about 40 a year
- 90
- reports, 12 months to August 2026
- 110 in the 12 months before
- 57.9%
- classified as malfunction
- 34.8% across the product code
- 0.8%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 252 reports that name the brand "Emboshield Nav6" (temporary carotid catheter for embolic capture), received between March 2020 and August 2026; the manufacturer given most often on reports is Abbott Vascular. Spellings of one product vary from report to report.
90 reports arrived in the 12 months to August 2026, down 18% from 110 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 (57.9%), injury (41.3%) and death (0.8%); 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 material separation (30.2%), improper or incorrect procedure or method (21.8%) and retraction problem (21.8%). The patient problems coded most often are device embedded in tissue or plaque, foreign body in patient and embolism/embolus. 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 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 |
|---|---|---|---|
| Material separation | 76 | 30.2% | 5.4% |
| Improper or incorrect procedure or method | 55 | 21.8% | 5.7% |
| Retraction problem | 55 | 21.8% | 3.8% |
| Difficult to removethe device was hard to remove | 47 | 18.7% | 15.6% |
| Breakthe device broke | 44 | 17.5% | 4.1% |
| Difficult to insertthe device was hard to insert | 38 | 15.1% | 3.4% |
| Deformation due to compressive stress | 32 | 12.7% | 1.9% |
| Difficult to advance | 31 | 12.3% | 2.5% |
| Device dislodged or dislocated | 26 | 10.3% | 1.1% |
| Stretched | 26 | 10.3% | 2.8% |
| Migrationthe device moved from where it was placed | 21 | 8.3% | 1.1% |
| Material split, cut or torn | 18 | 7.1% | 1.4% |
| Failure to advance | 15 | 6% | 1.8% |
| Material twisted/bent | 10 | 4% | 1.2% |
| Activation failure | 7 | 2.8% | 0.9% |
| Contamination /decontamination problem | 3 | 1.2% | 0.3% |
| Material too soft/flexible | 3 | 1.2% | 0.2% |
| Device difficult to setup or prepare | 2 | 0.8% | 0.4% |
| Premature activation | 2 | 0.8% | 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 |
|---|---|---|
| Device embedded in tissue or plaque | 14 | 5.6% |
| Foreign body in patientpart of a device left in the patient | 11 | 4.4% |
| Embolism/embolus | 10 | 4% |
| Obstruction/occlusion | 8 | 3.2% |
| Stroke/cva | 8 | 3.2% |
| Thrombosis/thrombus | 6 | 2.4% |
| Transient ischemic attack | 5 | 2% |
| Nervous system injury | 3 | 1.2% |
| Ischemia | 2 | 0.8% |
| Myocardial infarctionheart attack | 2 | 0.8% |
| Paresis | 2 | 0.8% |
| Perforation of vessels | 2 | 0.8% |
| Vascular dissection | 2 | 0.8% |
| Fatiguetiredness | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Emboshield Nav6 | Product code NTE | All MAUDE reports |
|---|---|---|---|
| Reports | 252 | 5,335 | 26,136,888 |
| Share of that pool | — | 4.7% | 0% |
| Classified as death, per 1,000 reports | 8 | 21 | 9 |
| Classified as injury | 41.3% | 62.7% | 36.2% |
| Classified as malfunction | 57.9% | 34.8% | 62.3% |
| Filed by the manufacturer | 97.6% | 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% |
| Spiderfx Embolic Protection Device | 232 | 0 | 6% |
| Rx Accunet Embolic Protection System | 429 | 0 | 2.1% |
| 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 Emboshield Nav6 reports
How many FDA reports name Emboshield Nav6?
252 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 90 in the latest 12 months.
What kinds of events are reported?
malfunction (57.9%), injury (41.3%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (30.2%), improper or incorrect procedure or method (21.8%), retraction problem (21.8%), difficult to remove (18.7%) and break (17.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.6%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Emboshield Nav6 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.