Devices › Catheter, coronary, atherectomy
Device brand name · Catheter coronary atherectomy
ROTAWIRE Drive: medical device reports filed with FDA
369 reports name it, 2021–2026. Manufacturer given most often on reports: Boston Scientific. Product code MCX.
- 369
- device reports naming the brand
- 0% of all MAUDE reports · about 69 a year
- 85
- reports, 12 months to August 2026
- 60 in the 12 months before
- 71%
- classified as malfunction
- 55.3% across the product code
- 3.5%
- classified as death, as reported
- 13 reports · not verified by FDA
FDA's MAUDE database holds 369 reports that name the brand "ROTAWIRE Drive" (catheter coronary atherectomy), received between March 2021 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
85 reports arrived in the 12 months to August 2026, up 42% from 60 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 (71%), injury (25.5%) and death (3.5%); across all catheter, coronary, atherectomy reports (product code MCX) death is recorded in 7.4% and malfunction in 55.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are entrapment of device (46.9%), detachment of device or device component (22.2%) and difficult to remove (9.5%). The patient problems coded most often are foreign body in patient, perforation 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 11,889 reports carrying product code MCX. 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 |
|---|---|---|---|
| Entrapment of device | 173 | 46.9% | 22.4% |
| Detachment of device or device componentpart of the device came off | 82 | 22.2% | 6.1% |
| Difficult to removethe device was hard to remove | 35 | 9.5% | 5.6% |
| Material deformation | 35 | 9.5% | 1.6% |
| Nonstandard device | 34 | 9.2% | 1.4% |
| Fracturea broken bone | 26 | 7% | 7% |
| Material integrity problema problem with the device material | 20 | 5.4% | 1.6% |
| Difficult to advance | 19 | 5.1% | 1.3% |
| Positioning problem | 15 | 4.1% | 0.5% |
| Deformation due to compressive stress | 12 | 3.3% | 0.3% |
| Device contamination with chemical or other material | 11 | 3% | 1.3% |
| Stretched | 11 | 3% | 0.4% |
| Device-device incompatibility | 7 | 1.9% | 0.4% |
| Defective devicethe device was defective | 6 | 1.6% | 0.7% |
| Device damaged by another device | 4 | 1.1% | 5.9% |
| Failure to advance | 3 | 0.8% | 2.6% |
| Material twisted/bent | 3 | 0.8% | 0.2% |
| Contamination | 2 | 0.5% | 0.3% |
| Poor visibility | 2 | 0.5% | 0% |
| Unsealed device packaging | 2 | 0.5% | 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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 51 | 13.8% |
| Perforation | 14 | 3.8% |
| Perforation of vessels | 10 | 2.7% |
| Cardiac arrestthe heart stopped | 4 | 1.1% |
| Chest painchest pain | 4 | 1.1% |
| Hemorrhage/blood loss/bleeding | 4 | 1.1% |
| Cardiac tamponade | 3 | 0.8% |
| Embolism/embolus | 3 | 0.8% |
| Myocardial infarctionheart attack | 3 | 0.8% |
| Obstruction/occlusion | 3 | 0.8% |
| Pericardial effusionfluid around the heart | 3 | 0.8% |
| Discomfortdiscomfort | 2 | 0.5% |
| Ischemia | 2 | 0.5% |
| Low blood pressure/ hypotension | 2 | 0.5% |
| Non specific ekg/ECG changes | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ROTAWIRE Drive | Product code MCX | All MAUDE reports |
|---|---|---|---|
| Reports | 369 | 11,889 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 35 | 74 | 9 |
| Classified as injury | 25.5% | 36.9% | 36.2% |
| Classified as malfunction | 71% | 55.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.4% | 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 MCX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| RotaLink? Plus | 1,957 | 42 | 4.4% |
| Rotablator Rotational Atherectomy System | 1,917 | 88 | 7% |
| Rotapro | 1,565 | 313 | 4.7% |
| Diamondback 360 Coronary Orbital Atherectomy System | 1,512 | 0 | 15.7% |
| RotaWire and wireClip Torquer | 1,462 | 84 | 3.8% |
| RotaLink Burr | 627 | 39 | 8.1% |
| Diamondback Coronary | 492 | 222 | 15.9% |
| AngioJet Ultra System Console | 162 | 11 | 1.2% |
| Rotalink Catheter | 154 | 0 | 13% |
| Rotablator Guide Wire | 352 | 0 | 3.7% |
| Diamondback 360 Peripheral Orbital Atherectomy System | 676 | 0 | 0.9% |
| AngioJet SOLENT omni | 671 | 26 | 1.3% |
| Diamondback 360 Orbital Atherectomy System | 241 | 0 | 3.3% |
| Selox JT 53 | 150 | 5 | 0% |
| Synergy | 14,271 | 84 | 3.5% |
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 ROTAWIRE Drive reports
How many FDA reports name ROTAWIRE Drive?
369 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 85 in the latest 12 months.
What kinds of events are reported?
malfunction (71%), injury (25.5%) and death (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
entrapment of device (46.9%), detachment of device or device component (22.2%), difficult to remove (9.5%), material deformation (9.5%) and nonstandard device (9.2%). 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 ROTAWIRE Drive 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.