Devices › Catheter, coronary, atherectomy
Device brand name · Catheter coronary atherectomy
Diamondback Coronary: medical device reports filed with FDA
492 reports name it, 2016–2026. Manufacturer given most often on reports: Cardiovascular Systems. Product code MCX.
- 492
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 222
- reports, 12 months to August 2026
- 198 in the 12 months before
- 19.5%
- classified as malfunction
- 55.3% across the product code
- 15.9%
- classified as death, as reported
- 78 reports · not verified by FDA
492 medical device reports received by FDA name the brand "Diamondback Coronary" (catheter coronary atherectomy); the manufacturer given most often on reports is Cardiovascular Systems; received from October 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
222 reports arrived in the 12 months to August 2026, up 12% from 198 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 injury (64.6%), malfunction (19.5%) and death (15.9%); 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 material separation (40.2%), device damaged by another device (17.5%) and unintended system motion (11.8%). The patient problems coded most often are perforation of vessels, foreign body in patient and vascular dissection. 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 |
|---|---|---|---|
| Material separation | 198 | 40.2% | 7.9% |
| Device damaged by another device | 86 | 17.5% | 5.9% |
| Unintended system motionthe device moved when it should not have | 58 | 11.8% | 1.3% |
| Improper or incorrect procedure or method | 38 | 7.7% | 0.4% |
| Difficult to removethe device was hard to remove | 34 | 6.9% | 5.6% |
| Unexpected shutdown | 22 | 4.5% | 0.3% |
| Entrapment of device | 20 | 4.1% | 22.4% |
| Difficult to advance | 14 | 2.8% | 1.3% |
| Failure to advance | 13 | 2.6% | 2.6% |
| Noise, audible | 5 | 1% | 1.2% |
| Off-label use | 4 | 0.8% | 0.1% |
| Air/gas in device | 3 | 0.6% | 0% |
| Deformation due to compressive stress | 3 | 0.6% | 0.3% |
| Poor visibility | 3 | 0.6% | 0% |
| Activation problem | 2 | 0.4% | 0% |
| Fluid/blood leak | 2 | 0.4% | 1.1% |
| Activation failure | 1 | 0.2% | 0% |
| Activation, positioning or separation problem | 1 | 0.2% | 0% |
| Breakthe device broke | 1 | 0.2% | 2.3% |
| Contamination /decontamination problem | 1 | 0.2% | 0% |
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 |
|---|---|---|
| Perforation of vessels | 115 | 23.4% |
| Foreign body in patientpart of a device left in the patient | 106 | 21.5% |
| Vascular dissection | 56 | 11.4% |
| Obstruction/occlusion | 54 | 11% |
| Myocardial infarctionheart attack | 53 | 10.8% |
| Cardiac arrestthe heart stopped | 42 | 8.5% |
| Low blood pressure/ hypotension | 35 | 7.1% |
| Arrhythmia | 16 | 3.3% |
| Pericardial effusionfluid around the heart | 14 | 2.8% |
| Embolism/embolus | 13 | 2.6% |
| Angina | 12 | 2.4% |
| Cardiac tamponade | 8 | 1.6% |
| Reduced blood flow | 8 | 1.6% |
| Cardiac enzyme elevation | 7 | 1.4% |
| Device embedded in tissue or plaque | 6 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Diamondback Coronary | Product code MCX | All MAUDE reports |
|---|---|---|---|
| Reports | 492 | 11,889 | 26,136,888 |
| Share of that pool | — | 4.1% | 0% |
| Classified as death, per 1,000 reports | 159 | 74 | 9 |
| Classified as injury | 64.6% | 36.9% | 36.2% |
| Classified as malfunction | 19.5% | 55.3% | 62.3% |
| Filed by the manufacturer | 92.1% | 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% |
| ROTAWIRE Drive | 369 | 85 | 3.5% |
| 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 Diamondback Coronary reports
How many FDA reports name Diamondback Coronary?
492 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 222 in the latest 12 months.
What kinds of events are reported?
injury (64.6%), malfunction (19.5%) and death (15.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (40.2%), device damaged by another device (17.5%), unintended system motion (11.8%), improper or incorrect procedure or method (7.7%) and difficult to remove (6.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (92.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Diamondback Coronary 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.