Devices › Wire, guide, catheter
Device brand name · Enroute st mod s hy us 95-014
Enroute St Mod S Hy Us 95-014: medical device reports filed with FDA
183 reports name it, 2018–2026. Manufacturer given most often on reports: Lake Region Medical. Product code DQX.
- 183
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 13
- reports, 12 months to August 2026
- 4 in the 12 months before
- 96.7%
- classified as malfunction
- 57.4% across the product code
- 1.6%
- classified as death, as reported
- 3 reports · not verified by FDA
183 medical device reports received by FDA name the brand "Enroute St Mod S Hy Us 95-014" (enroute st mod s hy us 95-014); the manufacturer given most often on reports is Lake Region Medical; received from January 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
13 reports arrived in the 12 months to August 2026, up 225% from 4 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 (96.7%), death (1.6%) and injury (1.6%); across all wire, guide, catheter reports (product code DQX) death is recorded in 2.8% and malfunction in 57.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to advance (60.7%), failure to advance (44.8%) and positioning problem (16.9%). The patient problems coded most often are vascular dissection, hemorrhagic stroke and perforation of vessels. 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 33,838 reports carrying product code DQX. 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 advance | 111 | 60.7% | 4.6% |
| Failure to advance | 82 | 44.8% | 4.8% |
| Positioning problem | 31 | 16.9% | 0.6% |
| Insufficient device problem information | 4 | 2.2% | 1.6% |
| Activation, positioning or separation problem | 3 | 1.6% | 0.2% |
| Material twisted/bent | 3 | 1.6% | 1.3% |
| Breakthe device broke | 2 | 1.1% | 11.4% |
| Malposition of device | 2 | 1.1% | 0.1% |
| Difficult or delayed positioning | 1 | 0.5% | 0.2% |
| Fracturea broken bone | 1 | 0.5% | 7.8% |
| Material deformation | 1 | 0.5% | 2% |
| Material fragmentation | 1 | 0.5% | 0.9% |
| Material integrity problema problem with the device material | 1 | 0.5% | 1.8% |
| Material perforation | 1 | 0.5% | 0.2% |
| Migrationthe device moved from where it was placed | 1 | 0.5% | 0% |
| Positioning failure | 1 | 0.5% | 0.1% |
| Unraveled material | 1 | 0.5% | 3.4% |
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 | 144 | 78.7% |
| Hemorrhagic stroke | 2 | 1.1% |
| Perforation of vessels | 2 | 1.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.5% |
| Bruise/contusion | 1 | 0.5% |
| Device embedded in tissue or plaque | 1 | 0.5% |
| Extravasation | 1 | 0.5% |
| Stroke/cva | 1 | 0.5% |
| Thrombosis/thrombus | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enroute St Mod S Hy Us 95-014 | Product code DQX | All MAUDE reports |
|---|---|---|---|
| Reports | 183 | 33,838 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 16 | 28 | 9 |
| Classified as injury | 1.6% | 38.9% | 36.2% |
| Classified as malfunction | 96.7% | 57.4% | 62.3% |
| Filed by the manufacturer | 100% | 88.6% | 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 DQX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| V-18 Control Wire | 554 | 47 | 0.7% |
| Amplatz Super Stiff | 658 | 50 | 4.7% |
| Hi-Torque Balance Middleweight Universal Guide Wire | 479 | 0 | 1.3% |
| Starter guidewire | 422 | 179 | 1.2% |
| Amplatz Super Stiff Guidewire | 403 | 0 | 3% |
| Acs Hi-Torque Balance Middleweight Guide Wire | 380 | 0 | 3.2% |
| Arrow Ra Cath Set 22 Ga X 1-3/8 | 346 | 0 | 0% |
| Radifocus Glidewire | 330 | 25 | 2.1% |
| V-14 Controlwire | 325 | 0 | 0.3% |
| Pt | 322 | 13 | 4% |
| V-14? Control Wire? | 305 | 25 | 0.3% |
| Acs Hi-Torque Balance Middleweight Guide Wire With Hydrocoat Hydrophilic Coating | 304 | 0 | 1.3% |
| Guide Wires | 374 | 0 | 1.6% |
| Runthrough Ns | 259 | 0 | 1.9% |
| Hi-Torque Pilot Guide Wire | 256 | 0 | 4.3% |
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 Enroute St Mod S Hy Us 95-014 reports
How many FDA reports name Enroute St Mod S Hy Us 95-014?
183 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
malfunction (96.7%), death (1.6%) and injury (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to advance (60.7%), failure to advance (44.8%), positioning problem (16.9%), insufficient device problem information (2.2%) and activation, positioning or separation problem (1.6%). 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 Enroute St Mod S Hy Us 95-014 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.