Devices › Temporary carotid catheter for embolic capture
Device brand name · Embolic protection device nte
Angioguard Rx Emboli Capture Guidewire System: medical device reports filed with FDA
317 reports name it, 2010–2016. Manufacturer given most often on reports: Cordis. Product code NTE.
- 317
- 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
- 39.1%
- classified as malfunction
- 34.8% across the product code
- 0.6%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 317 reports that name the brand "Angioguard Rx Emboli Capture Guidewire System" (embolic protection device nte), received between October 2010 and June 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 (59.3%), malfunction (39.1%) and death (0.6%); 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 (16.4%), stretched (6.9%) and unraveled material (5.4%). The patient problems coded most often are stroke/cva, low blood pressure/ hypotension and transient ischemic attack. 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 Angioguard Rx Emboli Capture Guidewire System was received in the five years to August 2026; the latest was received in June 2016.
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 | 52 | 16.4% | 15.6% |
| Stretched | 22 | 6.9% | 2.8% |
| Unraveled material | 17 | 5.4% | 1.3% |
| Retraction problem | 13 | 4.1% | 3.8% |
| Capturing problem | 9 | 2.8% | 0.1% |
| Complete blockage | 8 | 2.5% | 0.2% |
| Defective component | 8 | 2.5% | 0.5% |
| Failure to capture | 6 | 1.9% | 0.3% |
| Insufficient device problem information | 6 | 1.9% | 0.9% |
| Bent | 5 | 1.6% | 0.2% |
| Device damaged prior to usethe device was damaged before use | 4 | 1.3% | 0.2% |
| Fracturea broken bone | 4 | 1.3% | 0.9% |
| Kinkedthe tube or line kinked | 4 | 1.3% | 1.3% |
| Torn material | 4 | 1.3% | 0.7% |
| Device damaged by another device | 3 | 0.9% | 0.9% |
| Difficult to open or close | 3 | 0.9% | 0% |
| Occlusion within devicethe device blocked | 3 | 0.9% | 0.4% |
| Detachment of device component | 2 | 0.6% | 3.1% |
| Detachment of device or device componentpart of the device came off | 2 | 0.6% | 4.3% |
| Difficult to fold, unfold or collapse | 2 | 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 |
|---|---|---|
| Stroke/cva | 59 | 18.6% |
| Low blood pressure/ hypotension | 53 | 16.7% |
| Transient ischemic attack | 37 | 11.7% |
| Vascular system (circulation), impaired | 33 | 10.4% |
| Bradycardiaslow heart rate | 19 | 6% |
| Vascular dissection | 14 | 4.4% |
| Vasoconstriction | 14 | 4.4% |
| Infarction, cerebral | 10 | 3.2% |
| Neurological deficit/dysfunction | 8 | 2.5% |
| Intimal dissection | 7 | 2.2% |
| Cardiac arrestthe heart stopped | 4 | 1.3% |
| Deaththe patient died; cause not stated by this term | 4 | 1.3% |
| Dysphasia | 4 | 1.3% |
| Seizures | 3 | 0.9% |
| High blood pressure/ hypertension | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Angioguard Rx Emboli Capture Guidewire System | Product code NTE | All MAUDE reports |
|---|---|---|---|
| Reports | 317 | 5,335 | 26,136,888 |
| Share of that pool | — | 5.9% | 0% |
| Classified as death, per 1,000 reports | 6 | 21 | 9 |
| Classified as injury | 59.3% | 62.7% | 36.2% |
| Classified as malfunction | 39.1% | 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 Xp Emboli Capture Guidewire System | 275 | 0 | 0% |
| Emboshield Nav6 | 252 | 90 | 0.8% |
| 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 Angioguard Rx Emboli Capture Guidewire System reports
How many FDA reports name Angioguard Rx Emboli Capture Guidewire System?
317 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 (59.3%), malfunction (39.1%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (16.4%), stretched (6.9%), unraveled material (5.4%), retraction problem (4.1%) and capturing problem (2.8%). 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 Angioguard Rx Emboli Capture Guidewire 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.