Devices › Catheter, peripheral, atherectomy
Device brand name · Peripheral atherectomy device
Diamondback 360 Peripheral Orbital Atherectomy System: medical device reports filed with FDA
676 reports name it, 2014–2024. Manufacturer given most often on reports: Cardiovascular Systems. Product code MCW.
- 676
- device reports naming the brand
- 0% of all MAUDE reports · about 54 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 21.3%
- classified as malfunction
- 55.6% across the product code
- 0.9%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 676 reports that name the brand "Diamondback 360 Peripheral Orbital Atherectomy System" (peripheral atherectomy device), received between January 2014 and July 2024; the manufacturer given most often on reports is Cardiovascular Systems. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (77.8%), malfunction (21.3%) and death (0.9%); across all catheter, peripheral, atherectomy reports (product code MCW) death is recorded in 1.8% and malfunction in 55.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material separation (35.8%), entrapment of device (24.4%) and difficult to remove (3%). The patient problems coded most often are foreign body in patient, vascular dissection and device embedded in tissue or plaque. 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 8,514 reports carrying product code MCW. 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 | 242 | 35.8% | 7.8% |
| Entrapment of device | 165 | 24.4% | 12.2% |
| Difficult to removethe device was hard to remove | 20 | 3% | 7.1% |
| Detachment of device or device componentpart of the device came off | 14 | 2.1% | 13.2% |
| Infusion or flow problema problem with flow or infusion | 13 | 1.9% | 0.4% |
| Unexpected shutdown | 13 | 1.9% | 0.7% |
| Mechanical problema mechanical problem | 11 | 1.6% | 3.1% |
| Fluid/blood leak | 10 | 1.5% | 0.4% |
| Noise, audible | 10 | 1.5% | 1.9% |
| Unintended system motionthe device moved when it should not have | 10 | 1.5% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 1.3% | 1.5% |
| Off-label use | 8 | 1.2% | 0.2% |
| Device remains activated | 7 | 1% | 0.1% |
| Material twisted/bent | 6 | 0.9% | 0.3% |
| Sticking | 6 | 0.9% | 2.3% |
| Detachment of device component | 5 | 0.7% | 2.3% |
| Breakthe device broke | 4 | 0.6% | 15.6% |
| Device damaged by another device | 4 | 0.6% | 1.8% |
| Device-device incompatibility | 4 | 0.6% | 0.7% |
| Failure to advance | 4 | 0.6% | 1.8% |
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 | 177 | 26.2% |
| Vascular dissection | 83 | 12.3% |
| Device embedded in tissue or plaque | 69 | 10.2% |
| Perforation of vessels | 69 | 10.2% |
| Embolism/embolus | 42 | 6.2% |
| Vessel or plaque, device embedded in | 37 | 5.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 33 | 4.9% |
| Vascular system (circulation), impaired | 14 | 2.1% |
| Embolism | 10 | 1.5% |
| Embolus | 10 | 1.5% |
| Thrombosis/thrombus | 9 | 1.3% |
| Injurya physical injury | 8 | 1.2% |
| Thrombus | 8 | 1.2% |
| Painpain, site not specified | 7 | 1% |
| Vasoconstriction | 7 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Diamondback 360 Peripheral Orbital Atherectomy System | Product code MCW | All MAUDE reports |
|---|---|---|---|
| Reports | 676 | 8,514 | 26,136,888 |
| Share of that pool | — | 7.9% | 0% |
| Classified as death, per 1,000 reports | 9 | 18 | 9 |
| Classified as injury | 77.8% | 40.9% | 36.2% |
| Classified as malfunction | 21.3% | 55.6% | 62.3% |
| Filed by the manufacturer | 99.6% | 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 MCW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Rotarex | 1,340 | 373 | 0.7% |
| JETSTREAM XC Atherectomy Catheter | 741 | 71 | 0.3% |
| Jetstream Xc | 590 | 44 | 0% |
| Hawkone 6fr | 566 | 30 | 0% |
| Diamondback 360 Orbital Atherectomy System | 241 | 0 | 3.3% |
| Peripheral Rotalink Plus | 158 | 1 | 1.9% |
| JETSTREAM Atherectomy Catheter | 151 | 32 | 0.7% |
| Crosser Recanalization Catheter | 159 | 0 | 1.3% |
| Rotalink Catheter | 154 | 0 | 13% |
| Diamondback 360 Coronary Orbital Atherectomy System | 1,512 | 0 | 15.7% |
| Crosser Cto Recanalization Catheter | 362 | 0 | 0.3% |
| Fogarty Arterial Embolectomy Catheter | 1,165 | 37 | 0.2% |
| Rotablator Guide Wire | 352 | 0 | 3.7% |
| Crosser Cto Recanalization Catheters | 223 | 0 | 0% |
| Datascope | 356 | 0 | 7.3% |
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 Diamondback 360 Peripheral Orbital Atherectomy System reports
How many FDA reports name Diamondback 360 Peripheral Orbital Atherectomy System?
676 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (77.8%), malfunction (21.3%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (35.8%), entrapment of device (24.4%), difficult to remove (3%), detachment of device or device component (2.1%) and infusion or flow problem (1.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Diamondback 360 Peripheral Orbital Atherectomy System 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.