Devices › Wire, guide, catheter
Device brand name · Guidewire
Starter guidewire: medical device reports filed with FDA
422 reports name it, 2003–2026. Manufacturer given most often on reports: Lake Region Medical. Product code DQX.
- 422
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 179
- reports, 12 months to August 2026
- 85 in the 12 months before
- 73%
- classified as malfunction
- 57.4% across the product code
- 1.2%
- classified as death, as reported
- 5 reports · not verified by FDA
422 medical device reports received by FDA name the brand "Starter guidewire" (guidewire); the manufacturer given most often on reports is Lake Region Medical; received from March 2003 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
179 reports arrived in the 12 months to August 2026, up 111% from 85 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 (73%), injury (25.8%) and death (1.2%); 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 fracture (17.3%), entrapment of device (16.6%) and difficult to advance (6.2%). The patient problems coded most often are pericardial effusion, cardiac tamponade 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 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 |
|---|---|---|---|
| Fracturea broken bone | 73 | 17.3% | 7.8% |
| Entrapment of device | 70 | 16.6% | 5% |
| Difficult to advance | 26 | 6.2% | 4.6% |
| Difficult to removethe device was hard to remove | 22 | 5.2% | 15.4% |
| Failure to advance | 20 | 4.7% | 4.8% |
| Material deformation | 9 | 2.1% | 2% |
| Material split, cut or torn | 8 | 1.9% | 1.2% |
| Unraveled material | 6 | 1.4% | 3.4% |
| Detachment of device or device componentpart of the device came off | 4 | 0.9% | 5.8% |
| Insufficient device problem information | 4 | 0.9% | 1.6% |
| Material twisted/bent | 4 | 0.9% | 1.3% |
| Deformation due to compressive stress | 3 | 0.7% | 1.5% |
| Device contamination with chemical or other material | 3 | 0.7% | 0.4% |
| Breakthe device broke | 2 | 0.5% | 11.4% |
| Peeled/delaminated | 2 | 0.5% | 7.1% |
| Device contaminated during manufacture or shipping | 1 | 0.2% | 0.3% |
| Device damaged by another device | 1 | 0.2% | 0.8% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.2% | 0.7% |
| Device-device incompatibility | 1 | 0.2% | 0.1% |
| Flaked | 1 | 0.2% | 0.7% |
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 |
|---|---|---|
| Pericardial effusionfluid around the heart | 37 | 8.8% |
| Cardiac tamponade | 30 | 7.1% |
| Perforation | 11 | 2.6% |
| Hemorrhage/blood loss/bleeding | 6 | 1.4% |
| Low blood pressure/ hypotension | 4 | 0.9% |
| No patient involvement | 4 | 0.9% |
| Stroke | 4 | 0.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.7% |
| Cardiac arrestthe heart stopped | 3 | 0.7% |
| Air embolism | 2 | 0.5% |
| Cardiac perforation | 2 | 0.5% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.5% |
| Perforation of vessels | 2 | 0.5% |
| Thrombosis/thrombus | 2 | 0.5% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Starter guidewire | Product code DQX | All MAUDE reports |
|---|---|---|---|
| Reports | 422 | 33,838 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 12 | 28 | 9 |
| Classified as injury | 25.8% | 38.9% | 36.2% |
| Classified as malfunction | 73% | 57.4% | 62.3% |
| Filed by the manufacturer | 99.3% | 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% |
| 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% |
| Hi-Torque Command 18 Guide Wire | 245 | 0 | 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 Starter guidewire reports
How many FDA reports name Starter guidewire?
422 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 179 in the latest 12 months.
What kinds of events are reported?
malfunction (73%), injury (25.8%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (17.3%), entrapment of device (16.6%), difficult to advance (6.2%), difficult to remove (5.2%) and failure to advance (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Starter guidewire 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.