Temporary carotid catheter for embolic capture: medical device reports filed with FDA

5,335 reports carry this product code, 2004–2026; 14 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,335
reports with this product code: 0% of all MAUDE reports; 366
reports, 12 months to August 2026: 409 in the 12 months before; 34.8%
classified as malfunction: 62.3% across all reports; 2.1%
classified as death, as reported: 0.9% across all reports

Product code NTE is FDA's classification for "Temporary carotid catheter for embolic capture" (cardiovascular panel), a class 2 device. 5,335 medical device reports carry this product code, 0% of the MAUDE database, from September 2004 to August 2026.

366 reports arrived in the 12 months to August 2026, down 11% from 409 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 (62.7%), malfunction (34.8%) and death (2.1%). 14 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Emboshield Nav6 Embolic Protection System	1,004	0	1.7%	49.9%
ENROUTE Transcarotid Neuroprotection System	660	130	2%	4.1%
Spider Fx	527	65	2%	36.4%
Angioguard Rx	367	38	0.5%	49.6%
Enroute Neuroprotection System	331	0	0.6%	0.3%
Angioguard Rx Emboli Capture Guidewire System	316	0	0.6%	39.1%
Angioguard Xp Emboli Capture Guidewire System	272	0	0%	23.3%
Emboshield Nav6	252	90	0.8%	57.9%
Spiderfx Embolic Protection Device	216	0	6%	1.3%
Rx Accunet Embolic Protection System	212	0	2.1%	14%
FilterWire EZ	136	71	0.4%	82.1%
Filterwire Ez Emoblic Protection System	15	0	1.8%	17.1%
Abbott	1	0	7.5%	52.1%
Nanocross 0 14 Otw Pta Dilatation Catheter	1	22	0.5%	78.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Silk Road Medical	996	18.7%
Cordis	987	18.5%
Abbott Vascular	286	5.4%
Av-Temecula-Ct	283	5.3%
Ev3	262	4.9%
Invatec	256	4.8%
Abbott Vascular-Vascular Solutions	197	3.7%
Covidien	88	1.6%
Cordis US	71	1.3%
W L Gore & Associates	34	0.6%
Guidant Endovascular Solutions	17	0.3%
Cardiovascular Systems	14	0.3%
Medtronic Mexico	1	0%
Medtronic Vascular	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2.1%113

Injury62.7%3,344

Malfunction34.8%1,856

Other0.2%12

Not given0.2%10

Who filed

Manufacturer report98.1%5,234

Voluntary report0.6%33

User facility report0%0

Distributor report0%0

Not given1.3%68

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Difficult to removethe device was hard to remove	830	15.6%
Improper or incorrect procedure or method	303	5.7%
Material separation	286	5.4%
Detachment of device or device componentpart of the device came off	232	4.3%
Breakthe device broke	218	4.1%
Retraction problem	205	3.8%
Physical resistance	199	3.7%
Difficult to insertthe device was hard to insert	180	3.4%
Other (for use when an appropriate device code cannot be identified)	172	3.2%
Detachment of device component	166	3.1%
Stretched	152	2.8%
Difficult to advance	133	2.5%
Migration or expulsion of device	116	2.2%
Deformation due to compressive stress	104	1.9%
Failure to advance	95	1.8%
Material deformation	81	1.5%
Material split, cut or torn	73	1.4%
Unraveled material	71	1.3%
Kinkedthe tube or line kinked	69	1.3%
Entrapment of device	68	1.3%

Questions about temporary carotid catheter for embolic capture reports

What is product code NTE?

FDA's classification code for "Temporary carotid catheter for embolic capture", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,335 reports through August 2026, 366 of them in the latest 12 months.

Which brands appear most often?

Emboshield Nav6 Embolic Protection System (1,004), ENROUTE Transcarotid Neuroprotection System (660), Spider Fx (527), Angioguard Rx (367) and Enroute Neuroprotection System (331). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.