Devices › Temporary catheter, embolic protection, transcatheter intracardiac procedures
Device brand name · Embolic protection device
Sentinel Cerebral Protection System Us: medical device reports filed with FDA
167 reports name it, 2018–2024. Manufacturer given most often on reports: Claret Medical. Product code PUM.
- 167
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 77.8%
- classified as malfunction
- 78.6% across the product code
- 1.2%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 167 reports that name the brand "Sentinel Cerebral Protection System Us" (embolic protection device), received between October 2018 and October 2024; the manufacturer given most often on reports is Claret Medical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 2 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 (77.8%), injury (21%) and death (1.2%); across all temporary catheter, embolic protection, transcatheter intracardiac procedures reports (product code PUM) death is recorded in 1.4% and malfunction in 78.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to remove (49.1%), break (26.9%) and positioning failure (18%). The patient problems coded most often are stroke/cva, perforation of vessels 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
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 365 reports carrying product code PUM. 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 | 82 | 49.1% | 43.6% |
| Breakthe device broke | 45 | 26.9% | 17.5% |
| Positioning failure | 30 | 18% | 16.7% |
| Positioning problem | 30 | 18% | 15.9% |
| Defective devicethe device was defective | 13 | 7.8% | 9.3% |
| Device-device incompatibility | 8 | 4.8% | 4.4% |
| Detachment of device or device componentpart of the device came off | 7 | 4.2% | 3.8% |
| Difficult or delayed positioning | 7 | 4.2% | 4.7% |
| Material integrity problema problem with the device material | 6 | 3.6% | 7.7% |
| Failure to advance | 4 | 2.4% | 6.3% |
| Mechanical problema mechanical problem | 3 | 1.8% | 1.4% |
| Difficult to advance | 2 | 1.2% | 1.9% |
| Entrapment of device | 2 | 1.2% | 0.8% |
| Material deformation | 2 | 1.2% | 1.6% |
| Material twisted/bent | 2 | 1.2% | 1.4% |
| Contamination | 1 | 0.6% | 0.8% |
| Device contaminated during manufacture or shipping | 1 | 0.6% | 0.3% |
| Device contamination with chemical or other material | 1 | 0.6% | 0.8% |
| Difficult to open or close | 1 | 0.6% | 0.3% |
| Packaging problem | 1 | 0.6% | 0.5% |
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 | 18 | 10.8% |
| Perforation of vessels | 3 | 1.8% |
| Transient ischemic attack | 3 | 1.8% |
| Hemorrhage/blood loss/bleeding | 2 | 1.2% |
| Pseudoaneurysm | 2 | 1.2% |
| Vasoconstriction | 2 | 1.2% |
| Anemialow red blood cells | 1 | 0.6% |
| Deaththe patient died; cause not stated by this term | 1 | 0.6% |
| Eye injury | 1 | 0.6% |
| Hemorrhage, cerebral | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
| Thromboembolism | 1 | 0.6% |
| Thrombosis/thrombus | 1 | 0.6% |
| Vascular dissection | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sentinel Cerebral Protection System Us | Product code PUM | All MAUDE reports |
|---|---|---|---|
| Reports | 167 | 365 | 26,136,888 |
| Share of that pool | — | 45.8% | 0% |
| Classified as death, per 1,000 reports | 12 | 14 | 9 |
| Classified as injury | 21% | 20% | 36.2% |
| Classified as malfunction | 77.8% | 78.6% | 62.3% |
| Filed by the manufacturer | 100% | 88.5% | 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."
Questions about Sentinel Cerebral Protection System Us reports
How many FDA reports name Sentinel Cerebral Protection System Us?
167 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?
malfunction (77.8%), injury (21%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (49.1%), break (26.9%), positioning failure (18%), positioning problem (18%) and defective device (7.8%). 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 Sentinel Cerebral Protection System Us 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.