Devices › Introducer, catheter
Device brand name · Guiding sheath
Halo One Thin-Walled Guiding Sheath: medical device reports filed with FDA
159 reports name it, 2016–2026. Manufacturer given most often on reports: Clearstream Technologies. Product code DYB.
- 159
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 23
- reports, 12 months to August 2026
- 30 in the 12 months before
- 91.8%
- classified as malfunction
- 64.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
159 medical device reports received by FDA name the brand "Halo One Thin-Walled Guiding Sheath" (guiding sheath); the manufacturer given most often on reports is Clearstream Technologies; received from July 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
23 reports arrived in the 12 months to August 2026, down 23% from 30 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 (91.8%) and injury (8.2%); 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 deformation (37.1%), material split, cut or torn (22%) and failure to advance (19.5%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, hemorrhage/blood loss/bleeding and perforation. 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 deformation | 59 | 37.1% | 3.3% |
| Material split, cut or torn | 35 | 22% | 3.8% |
| Failure to advance | 31 | 19.5% | 1.7% |
| Connection problema connection problem | 18 | 11.3% | 0.2% |
| Difficult to insertthe device was hard to insert | 17 | 10.7% | 3.1% |
| Unraveled material | 13 | 8.2% | 1.7% |
| Device contamination with chemical or other material | 12 | 7.5% | 0.5% |
| Breakthe device broke | 7 | 4.4% | 7.5% |
| Leak/splashthe device leaked | 5 | 3.1% | 4.4% |
| Packaging problem | 4 | 2.5% | 0.2% |
| Detachment of device or device componentpart of the device came off | 3 | 1.9% | 4.5% |
| Difficult to advance | 3 | 1.9% | 1.9% |
| Retraction problem | 3 | 1.9% | 0.1% |
| Device-device incompatibility | 2 | 1.3% | 1.4% |
| Material separation | 2 | 1.3% | 12.3% |
| Contamination | 1 | 0.6% | 0.1% |
| Device contamination with body fluid | 1 | 0.6% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.6% | 0.2% |
| Device dislodged or dislocated | 1 | 0.6% | 0.2% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.6% | 0.1% |
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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 2.5% |
| Hemorrhage/blood loss/bleeding | 4 | 2.5% |
| Perforation | 3 | 1.9% |
| Painpain, site not specified | 2 | 1.3% |
| Swelling/ edema | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Halo One Thin-Walled Guiding Sheath | Product code DYB | All MAUDE reports |
|---|---|---|---|
| Reports | 159 | 41,190 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 33 | 9 |
| Classified as injury | 8.2% | 31.2% | 36.2% |
| Classified as malfunction | 91.8% | 64.6% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Edwards eSheath+ Introducer Set | 974 | 393 | 3.1% |
| 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% |
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 Halo One Thin-Walled Guiding Sheath reports
How many FDA reports name Halo One Thin-Walled Guiding Sheath?
159 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 23 in the latest 12 months.
What kinds of events are reported?
malfunction (91.8%) and injury (8.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (37.1%), material split, cut or torn (22%), failure to advance (19.5%), connection problem (11.3%) and difficult to insert (10.7%). 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 Halo One Thin-Walled Guiding Sheath 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.