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Device brand name · Introducer catheter
Edwards eSheath+ Introducer Set: medical device reports filed with FDA
974 reports name it, 2022–2026. Manufacturer given most often on reports: Edwards Lifesciences. Product code DYB.
- 974
- device reports naming the brand
- 0% of all MAUDE reports · about 217 a year
- 393
- reports, 12 months to August 2026
- 260 in the 12 months before
- 61.3%
- classified as malfunction
- 64.6% across the product code
- 3.1%
- classified as death, as reported
- 30 reports · not verified by FDA
974 medical device reports received by FDA name the brand "Edwards eSheath+ Introducer Set" (introducer catheter); the manufacturer given most often on reports is Edwards Lifesciences; received from January 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
393 reports arrived in the 12 months to August 2026, up 51% from 260 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 (61.3%), injury (35.6%) and death (3.1%); across all introducer, catheter reports (product code DYB) death is recorded in 3.3% and malfunction in 64.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material split, cut or torn (47.6%), physical resistance/sticking (31.2%) and material puncture/hole (18.7%). The patient problems coded most often are vascular dissection, perforation of vessels and hemorrhage/blood loss/bleeding. 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 41,190 reports carrying product code DYB. 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 split, cut or torn | 464 | 47.6% | 3.8% |
| Physical resistance/sticking | 304 | 31.2% | 2.1% |
| Material puncture/hole | 182 | 18.7% | 1.9% |
| Peeled/delaminated | 168 | 17.2% | 1.4% |
| Difficult to insertthe device was hard to insert | 77 | 7.9% | 3.1% |
| Detachment of device or device componentpart of the device came off | 68 | 7% | 4.5% |
| Difficult to advance | 37 | 3.8% | 1.9% |
| Difficult to removethe device was hard to remove | 30 | 3.1% | 2.9% |
| Material integrity problema problem with the device material | 29 | 3% | 1% |
| Deformation due to compressive stress | 24 | 2.5% | 0.6% |
| Material separation | 20 | 2.1% | 12.3% |
| Failure to advance | 14 | 1.4% | 1.7% |
| Activation failure | 11 | 1.1% | 0% |
| Material twisted/bent | 11 | 1.1% | 0.8% |
| Patient device interaction problem | 9 | 0.9% | 2.4% |
| Breakthe device broke | 3 | 0.3% | 7.5% |
| Device contaminated during manufacture or shipping | 3 | 0.3% | 0.2% |
| Device damaged by another device | 2 | 0.2% | 0.2% |
| Material deformation | 2 | 0.2% | 3.3% |
| Material fragmentation | 2 | 0.2% | 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 |
|---|---|---|
| Vascular dissection | 153 | 15.7% |
| Perforation of vessels | 58 | 6% |
| Hemorrhage/blood loss/bleeding | 37 | 3.8% |
| Foreign body in patientpart of a device left in the patient | 14 | 1.4% |
| Obstruction/occlusion | 12 | 1.2% |
| Stenosis | 9 | 0.9% |
| Low blood pressure/ hypotension | 8 | 0.8% |
| Hematomaa collection of blood under the skin or in tissue | 6 | 0.6% |
| Foreign body embolism | 5 | 0.5% |
| Great vessel perforation | 5 | 0.5% |
| Pseudoaneurysm | 5 | 0.5% |
| Rupturethe device burst | 5 | 0.5% |
| Stroke/cva | 5 | 0.5% |
| Embolism/embolus | 4 | 0.4% |
| Aortic dissection | 3 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Edwards eSheath+ Introducer Set | Product code DYB | All MAUDE reports |
|---|---|---|---|
| Reports | 974 | 41,190 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 31 | 33 | 9 |
| Classified as injury | 35.6% | 31.2% | 36.2% |
| Classified as malfunction | 61.3% | 64.6% | 62.3% |
| Filed by the manufacturer | 99% | 93.6% | 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 DYB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Vizigo | 1,560 | 873 | 0.4% |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath Medium | 1,381 | 0 | 0.1% |
| Micra | 7,144 | 524 | 8.4% |
| GORE DrySeal Flex Introducer Sheath | 1,177 | 283 | 5.3% |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath - Medium | 885 | 19 | 0.2% |
| Swartz Braided Transseptal Guiding Introducer, SL0, 63 cm Length, 8.5 F | 878 | 212 | 1.5% |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath Small | 870 | 0 | 0% |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath - Small | 707 | 11 | 0% |
| Glidesheath Slender | 625 | 95 | 0% |
| Flexor Ansel Guiding Sheath | 575 | 26 | 0.5% |
| Edwards eSheath Introducer Set | 1,393 | 15 | 9.7% |
| Flexor Raabe Guiding Sheath | 539 | 30 | 1.1% |
| Fast-Cath Transseptal Guiding Introducer Swartz SL Transseptal Series, SL1 8. | 505 | 26 | 0.8% |
| Edwards Transfemoral Esheath Unknown | 504 | 9 | 44.6% |
| Swartz Braided Transseptal Introducer, SL0, 8.5 F | 479 | 98 | 0% |
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 Edwards eSheath+ Introducer Set reports
How many FDA reports name Edwards eSheath+ Introducer Set?
974 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 393 in the latest 12 months.
What kinds of events are reported?
malfunction (61.3%), injury (35.6%) and death (3.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material split, cut or torn (47.6%), physical resistance/sticking (31.2%), material puncture/hole (18.7%), peeled/delaminated (17.2%) and difficult to insert (7.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Edwards eSheath+ Introducer Set 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.