Devices › Drug-eluting percutaneous transluminal coronary angioplasty catheter
Device brand name · Drug-eluting percutaneous transluminal coronary angioplasty catheter
Agent: medical device reports filed with FDA
674 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code OOB.
- 674
- device reports naming the brand
- 0% of all MAUDE reports · about 80 a year
- 304
- reports, 12 months to August 2026
- 194 in the 12 months before
- 61.6%
- classified as malfunction
- 57.9% across the product code
- 10.1%
- classified as death, as reported
- 68 reports · not verified by FDA
674 medical device reports received by FDA name the brand "Agent" (drug-eluting percutaneous transluminal coronary angioplasty catheter); the manufacturer given most often on reports is Boston Scientific; received from February 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
304 reports arrived in the 12 months to August 2026, up 57% from 194 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 (61.6%), injury (28.3%) and death (10.1%); across all drug-eluting percutaneous transluminal coronary angioplasty catheter reports (product code OOB) death is recorded in 11.4% and malfunction in 57.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (32%), break (14.2%) and failure to advance (11.9%). The patient problems coded most often are myocardial infarction, restenosis 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 598 reports carrying product code OOB. 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 | 216 | 32% | 32.8% |
| Breakthe device broke | 96 | 14.2% | 13.2% |
| Failure to advance | 80 | 11.9% | 12.4% |
| Nonstandard device | 42 | 6.2% | 6.9% |
| Difficult to advance | 35 | 5.2% | 4.8% |
| Entrapment of device | 28 | 4.2% | 4.7% |
| Difficult to removethe device was hard to remove | 20 | 3% | 3.3% |
| Inflation problem | 19 | 2.8% | 2.8% |
| Material deformation | 17 | 2.5% | 1.7% |
| Material integrity problema problem with the device material | 12 | 1.8% | 1.3% |
| Leak/splashthe device leaked | 11 | 1.6% | 1% |
| Deformation due to compressive stress | 10 | 1.5% | 1.7% |
| Physical resistance/sticking | 9 | 1.3% | 1.3% |
| Device-device incompatibility | 8 | 1.2% | 1.3% |
| Detachment of device or device componentpart of the device came off | 6 | 0.9% | 0.8% |
| Failure to deflate | 6 | 0.9% | 1% |
| Mechanical jam | 6 | 0.9% | 1% |
| Material separation | 4 | 0.6% | 0.7% |
| Contamination | 3 | 0.4% | 0.3% |
| Device contamination with chemical or other material | 3 | 0.4% | 0.3% |
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 |
|---|---|---|
| Myocardial infarctionheart attack | 86 | 12.8% |
| Restenosis | 80 | 11.9% |
| Vascular dissection | 52 | 7.7% |
| Cardiac arrestthe heart stopped | 43 | 6.4% |
| Cardiogenic shockshock from the heart failing to pump | 30 | 4.5% |
| Angina | 25 | 3.7% |
| Chest painchest pain | 24 | 3.6% |
| Cardiac enzyme elevation | 23 | 3.4% |
| Heart failure/congestive heart failure | 23 | 3.4% |
| Perforation of vessels | 18 | 2.7% |
| Hemorrhage/blood loss/bleeding | 14 | 2.1% |
| Hematomaa collection of blood under the skin or in tissue | 12 | 1.8% |
| Ischemia | 12 | 1.8% |
| Cardiac tamponade | 11 | 1.6% |
| Dyspneashortness of breath | 11 | 1.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Agent | Product code OOB | All MAUDE reports |
|---|---|---|---|
| Reports | 674 | 598 | 26,136,888 |
| Share of that pool | — | 112.7% | 0% |
| Classified as death, per 1,000 reports | 101 | 114 | 9 |
| Classified as injury | 28.3% | 30.6% | 36.2% |
| Classified as malfunction | 61.6% | 57.9% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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."
Questions about Agent reports
How many FDA reports name Agent?
674 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 304 in the latest 12 months.
What kinds of events are reported?
malfunction (61.6%), injury (28.3%) and death (10.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (32%), break (14.2%), failure to advance (11.9%), nonstandard device (6.2%) and difficult to advance (5.2%). 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 Agent 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.