Devices › Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Device brand name · Catheters transluminal coronary angioplasty percutaneous
Flextome Cutting Balloon: medical device reports filed with FDA
1,656 reports name it, 2009–2022. Manufacturer given most often on reports: Boston Scientific - Galway. Product code NWX.
- 1,656
- device reports naming the brand
- 0% of all MAUDE reports · about 97 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.8%
- classified as malfunction
- 93.4% across the product code
- 0.3%
- classified as death, as reported
- 5 reports · not verified by FDA
1,656 medical device reports received by FDA name the brand "Flextome Cutting Balloon" (catheters transluminal coronary angioplasty percutaneous); the manufacturer given most often on reports is Boston Scientific - Galway; received from June 2009 to December 2022. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 malfunction (93.8%), injury (5.9%) and death (0.3%); across all catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring reports (product code NWX) death is recorded in 0.7% and malfunction in 93.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (65%), failure to advance (7.9%) and break (7.2%). The patient problems coded most often are no patient involvement, perforation of vessels and intimal 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 7,792 reports carrying product code NWX. 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 rupture | 1,077 | 65% | 70.9% |
| Failure to advance | 131 | 7.9% | 5.4% |
| Breakthe device broke | 119 | 7.2% | 7.6% |
| Difficult to removethe device was hard to remove | 69 | 4.2% | 3.5% |
| Inflation problem | 51 | 3.1% | 2.5% |
| Leak/splashthe device leaked | 41 | 2.5% | 2% |
| Detachment of device component | 38 | 2.3% | 1% |
| Device damaged prior to usethe device was damaged before use | 36 | 2.2% | 0.3% |
| Detachment of device or device componentpart of the device came off | 31 | 1.9% | 2.7% |
| Entrapment of device | 31 | 1.9% | 2.8% |
| Fracturea broken bone | 22 | 1.3% | 0.2% |
| Material deformation | 16 | 1% | 1.8% |
| Deflation problem | 12 | 0.7% | 0.6% |
| Kinkedthe tube or line kinked | 12 | 0.7% | 0.2% |
| Material integrity problema problem with the device material | 11 | 0.7% | 1.5% |
| Bent | 7 | 0.4% | 0% |
| Material puncture/hole | 7 | 0.4% | 0.6% |
| Device contamination with chemical or other material | 6 | 0.4% | 0.1% |
| Fluid/blood leak | 6 | 0.4% | 0.7% |
| Difficult to advance | 5 | 0.3% | 1.4% |
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 |
|---|---|---|
| No patient involvement | 90 | 5.4% |
| Perforation of vessels | 17 | 1% |
| Intimal dissection | 15 | 0.9% |
| Device embedded in tissue or plaque | 10 | 0.6% |
| Vascular dissection | 10 | 0.6% |
| Chest painchest pain | 5 | 0.3% |
| Deaththe patient died; cause not stated by this term | 4 | 0.2% |
| Obstruction/occlusion | 4 | 0.2% |
| Cardiac arrestthe heart stopped | 3 | 0.2% |
| Chest tightness/pressure | 3 | 0.2% |
| Low blood pressure/ hypotension | 3 | 0.2% |
| Angina | 2 | 0.1% |
| Cardiac tamponade | 2 | 0.1% |
| Injurya physical injury | 2 | 0.1% |
| Ischemia | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Flextome Cutting Balloon | Product code NWX | All MAUDE reports |
|---|---|---|---|
| Reports | 1,656 | 7,792 | 26,136,888 |
| Share of that pool | — | 21.3% | 0% |
| Classified as death, per 1,000 reports | 3 | 7 | 9 |
| Classified as injury | 5.9% | 5.9% | 36.2% |
| Classified as malfunction | 93.8% | 93.4% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.4% | 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 NWX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| WOLVERINE Coronary Cutting Balloon MONORAIL | 4,535 | 746 | 0.2% |
| Small Peripheral Cutting Balloon | 927 | 0 | 0% |
| Wolverine Coronary Cutting Balloon | 380 | 59 | 4.7% |
| Wolverine Peripheral Cutting Balloon | 355 | 81 | 0% |
| Emerge | 3,724 | 168 | 1.8% |
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 Flextome Cutting Balloon reports
How many FDA reports name Flextome Cutting Balloon?
1,656 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?
malfunction (93.8%), injury (5.9%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (65%), failure to advance (7.9%), break (7.2%), difficult to remove (4.2%) and inflation problem (3.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Flextome Cutting Balloon 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.