Devices › Catheter, peripheral, atherectomy
Device brand name · Catheter peripheral atherectomy
JETSTREAM XC Atherectomy Catheter: medical device reports filed with FDA
741 reports name it, 2014–2026. Manufacturer given most often on reports: Boston Scientific. Product code MCW.
- 741
- device reports naming the brand
- 0% of all MAUDE reports · about 61 a year
- 71
- reports, 12 months to August 2026
- 46 in the 12 months before
- 79.2%
- classified as malfunction
- 55.6% across the product code
- 0.3%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 741 reports that name the brand "JETSTREAM XC Atherectomy Catheter" (catheter peripheral atherectomy), received between May 2014 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
71 reports arrived in the 12 months to August 2026, up 54% from 46 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 (79.2%), injury (20.5%) and death (0.3%); 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 entrapment of device (37.9%), aspiration issue (13.5%) and mechanical problem (10.5%). The patient problems coded most often are embolism, reocclusion 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 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 |
|---|---|---|---|
| Entrapment of device | 281 | 37.9% | 12.2% |
| Aspiration issue | 100 | 13.5% | 1.5% |
| Mechanical problema mechanical problem | 78 | 10.5% | 3.1% |
| Suction problem | 50 | 6.7% | 2.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 30 | 4% | 1.5% |
| Difficult to removethe device was hard to remove | 27 | 3.6% | 7.1% |
| Material deformation | 24 | 3.2% | 6.5% |
| Breakthe device broke | 18 | 2.4% | 15.6% |
| Leak/splashthe device leaked | 18 | 2.4% | 1.4% |
| Suction failure | 16 | 2.2% | 0.3% |
| Noise, audible | 14 | 1.9% | 1.9% |
| Detachment of device or device componentpart of the device came off | 11 | 1.5% | 13.2% |
| Failure to advance | 10 | 1.3% | 1.8% |
| Mechanical jam | 10 | 1.3% | 5.2% |
| Device damaged by another device | 9 | 1.2% | 1.8% |
| Fracturea broken bone | 9 | 1.2% | 2.8% |
| Unexpected shutdown | 9 | 1.2% | 0.7% |
| Difficult to advance | 8 | 1.1% | 2% |
| Material separation | 8 | 1.1% | 7.8% |
| Defective devicethe device was defective | 7 | 0.9% | 0.6% |
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 |
|---|---|---|
| Embolism | 31 | 4.2% |
| Reocclusion | 29 | 3.9% |
| Vascular dissection | 27 | 3.6% |
| Perforation of vessels | 15 | 2% |
| Intimal dissection | 12 | 1.6% |
| Painpain, site not specified | 11 | 1.5% |
| Embolism/embolus | 7 | 0.9% |
| No patient involvement | 6 | 0.8% |
| Hematomaa collection of blood under the skin or in tissue | 5 | 0.7% |
| Hemorrhage/blood loss/bleeding | 5 | 0.7% |
| Thromboembolism | 5 | 0.7% |
| Foreign body in patientpart of a device left in the patient | 4 | 0.5% |
| Occlusion | 4 | 0.5% |
| Perforation | 4 | 0.5% |
| Blood loss | 3 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | JETSTREAM XC Atherectomy Catheter | Product code MCW | All MAUDE reports |
|---|---|---|---|
| Reports | 741 | 8,514 | 26,136,888 |
| Share of that pool | — | 8.7% | 0% |
| Classified as death, per 1,000 reports | 3 | 18 | 9 |
| Classified as injury | 20.5% | 40.9% | 36.2% |
| Classified as malfunction | 79.2% | 55.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| Diamondback 360 Peripheral Orbital Atherectomy System | 676 | 0 | 0.9% |
| 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 JETSTREAM XC Atherectomy Catheter reports
How many FDA reports name JETSTREAM XC Atherectomy Catheter?
741 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 71 in the latest 12 months.
What kinds of events are reported?
malfunction (79.2%), injury (20.5%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
entrapment of device (37.9%), aspiration issue (13.5%), mechanical problem (10.5%), suction problem (6.7%) and device operates differently than expected (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that JETSTREAM XC Atherectomy Catheter 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.