Devices › Stylet for catheter, gastro-urology
Device brand name · Stylet for catheter gastro-urology
Jagwire: medical device reports filed with FDA
1,325 reports name it, 2005–2026. Manufacturer given most often on reports: Boston Scientific - Costa Rica Coyol. Product code EZB.
- 1,325
- device reports naming the brand
- 0% of all MAUDE reports · about 62 a year
- 22
- reports, 12 months to August 2026
- 6 in the 12 months before
- 82.3%
- classified as malfunction
- 79.2% across the product code
- 0.7%
- classified as death, as reported
- 9 reports · not verified by FDA
1,325 medical device reports received by FDA name the brand "Jagwire" (stylet for catheter gastro-urology); the manufacturer given most often on reports is Boston Scientific - Costa Rica Coyol; received from January 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
22 reports arrived in the 12 months to August 2026, up 267% from 6 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 (82.3%), injury (17.1%) and death (0.7%); across all stylet for catheter, gastro-urology reports (product code EZB) death is recorded in 1% and malfunction in 79.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device component (64.2%), peeled/delaminated (11%) and device damaged prior to use (3.7%). The patient problems coded most often are no patient involvement, nonresorbable materials, unretrieved in body and therapy/non-surgical treatment, additional. 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 2,451 reports carrying product code EZB. 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 |
|---|---|---|---|
| Detachment of device component | 850 | 64.2% | 27.9% |
| Peeled/delaminated | 146 | 11% | 13.1% |
| Device damaged prior to usethe device was damaged before use | 49 | 3.7% | 2.7% |
| Tip breakage | 45 | 3.4% | 2.6% |
| Breakthe device broke | 43 | 3.2% | 9.9% |
| Device, or device fragments remain in patient | 42 | 3.2% | 2.6% |
| Difficult to removethe device was hard to remove | 22 | 1.7% | 1.6% |
| Other (for use when an appropriate device code cannot be identified) | 19 | 1.4% | 1.2% |
| Detachment of device or device componentpart of the device came off | 17 | 1.3% | 7.1% |
| Tears, rips, holes in device, device material | 17 | 1.3% | 0.9% |
| Failure to advance | 15 | 1.1% | 0.9% |
| Wire(s), breakage of | 14 | 1.1% | 1.1% |
| Difficult to insertthe device was hard to insert | 9 | 0.7% | 1.3% |
| Physical resistance | 8 | 0.6% | 0.5% |
| Kinkedthe tube or line kinked | 7 | 0.5% | 0.4% |
| Material frayed | 6 | 0.5% | 1% |
| Difficult to advance | 5 | 0.4% | 1.5% |
| Fracturea broken bone | 5 | 0.4% | 0.6% |
| Loose | 4 | 0.3% | 0.3% |
| Device contamination with chemical or other material | 3 | 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 |
|---|---|---|
| No patient involvement | 58 | 4.4% |
| Nonresorbable materials, unretrieved in body | 33 | 2.5% |
| Therapy/non-surgical treatment, additional | 22 | 1.7% |
| Perforation | 15 | 1.1% |
| Device embedded in tissue or plaque | 14 | 1.1% |
| Surgical procedure, additional | 14 | 1.1% |
| Foreign body, removal of | 8 | 0.6% |
| Deaththe patient died; cause not stated by this term | 7 | 0.5% |
| Inflammationinflammation | 7 | 0.5% |
| Therapy/non-surgical treatment, aborted/stopped | 5 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 4 | 0.3% |
| Hemorrhage/blood loss/bleeding | 3 | 0.2% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 0.2% |
| Cholangitis | 2 | 0.2% |
| Septic shockshock arising from infection | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Jagwire | Product code EZB | All MAUDE reports |
|---|---|---|---|
| Reports | 1,325 | 2,451 | 26,136,888 |
| Share of that pool | — | 54.1% | 0% |
| Classified as death, per 1,000 reports | 7 | 10 | 9 |
| Classified as injury | 17.1% | 19.6% | 36.2% |
| Classified as malfunction | 82.3% | 79.2% | 62.3% |
| Filed by the manufacturer | 99.7% | 96.1% | 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 EZB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sensor | 1,053 | 50 | 0.3% |
| NiCore Nitinol Guidewire | 201 | 45 | 0% |
| Amplatz Super Stiff | 658 | 50 | 4.7% |
| Zipwire Hydrophilic Guidewire | 279 | 0 | 0% |
| Pathfinder | 196 | 0 | 0% |
| Amplatz Super Stiff Guidewire | 403 | 0 | 3% |
| Boston Scientific | 580 | 5 | 3.3% |
| Latex Foley Catheter | 1,368 | 7 | 0% |
| Guidewire | 154 | 15 | 0.6% |
| Hiwire Nitinol Hydrophilic Wire Guide | 150 | 9 | 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 Jagwire reports
How many FDA reports name Jagwire?
1,325 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.
What kinds of events are reported?
malfunction (82.3%), injury (17.1%) and death (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device component (64.2%), peeled/delaminated (11%), device damaged prior to use (3.7%), tip breakage (3.4%) and break (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) 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 Jagwire 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.