Devices › Catheters, transluminal coronary angioplasty, percutaneous
Device brand name · Catheters transluminal coronary angioplasty percutaneous
Apex Monorail: medical device reports filed with FDA
603 reports name it, 2007–2011. Manufacturer given most often on reports: Boston Scientific. Product code LOX.
- 603
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 84.6%
- classified as malfunction
- 85.5% across the product code
- 1.7%
- classified as death, as reported
- 10 reports · not verified by FDA
FDA's MAUDE database holds 603 reports that name the brand "Apex Monorail" (catheters transluminal coronary angioplasty percutaneous), received between October 2007 and October 2011; the manufacturer given most often on reports is Boston Scientific. 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 malfunction (84.6%), injury (13.3%) and death (1.7%); across all catheters, transluminal coronary angioplasty, percutaneous reports (product code LOX) death is recorded in 1.3% and malfunction in 85.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are balloon rupture (37.5%), material rupture (28.4%) and difficult to remove (4.5%). The patient problems coded most often are intimal dissection, surgical procedure, additional and death. 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
No report naming Apex Monorail was received in the five years to August 2026; the latest was received in October 2011.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 43,618 reports carrying product code LOX. 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 |
|---|---|---|---|
| Balloon rupture | 226 | 37.5% | 10.2% |
| Material rupture | 171 | 28.4% | 38.3% |
| Difficult to removethe device was hard to remove | 27 | 4.5% | 11.3% |
| Shaft break | 20 | 3.3% | 1.9% |
| Breakthe device broke | 15 | 2.5% | 7.4% |
| Failure to advance | 15 | 2.5% | 5.4% |
| Balloon burst | 14 | 2.3% | 1.2% |
| Inflation problem | 9 | 1.5% | 5.6% |
| Kinkedthe tube or line kinked | 8 | 1.3% | 1.8% |
| Physical resistance | 8 | 1.3% | 2.3% |
| Fracturea broken bone | 7 | 1.2% | 0.8% |
| Balloon pinhole | 6 | 1% | 0.1% |
| Deflation problem | 5 | 0.8% | 5.9% |
| Detachment of device component | 5 | 0.8% | 4.3% |
| Device damaged prior to usethe device was damaged before use | 5 | 0.8% | 0.7% |
| Entrapment of device | 5 | 0.8% | 1.5% |
| Hole in material | 5 | 0.8% | 0.4% |
| Sticking | 5 | 0.8% | 0.7% |
| Burst container or vessel | 4 | 0.7% | 2.2% |
| Detachment of device or device componentpart of the device came off | 4 | 0.7% | 1.6% |
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 |
|---|---|---|
| Intimal dissection | 37 | 6.1% |
| Surgical procedure, additional | 23 | 3.8% |
| Deaththe patient died; cause not stated by this term | 12 | 2% |
| No patient involvement | 9 | 1.5% |
| Perforation | 9 | 1.5% |
| Perforation of vessels | 8 | 1.3% |
| Chest painchest pain | 7 | 1.2% |
| Low blood pressure/ hypotension | 4 | 0.7% |
| Vascular dissection | 4 | 0.7% |
| Cardiac tamponade | 3 | 0.5% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 3 | 0.5% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 3 | 0.5% |
| Cardiac arrestthe heart stopped | 2 | 0.3% |
| Cardiogenic shockshock from the heart failing to pump | 2 | 0.3% |
| Device embedded in tissue or plaque | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Apex Monorail | Product code LOX | All MAUDE reports |
|---|---|---|---|
| Reports | 603 | 43,618 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 17 | 13 | 9 |
| Classified as injury | 13.3% | 12.9% | 36.2% |
| Classified as malfunction | 84.6% | 85.5% | 62.3% |
| Filed by the manufacturer | 99.3% | 97.7% | 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 LOX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| NC Emerge | 5,690 | 543 | 1.4% |
| Nc Trek Coronary Dilatation Catheter | 4,689 | 0 | 0.5% |
| Emerge | 3,724 | 168 | 1.8% |
| NC Quantum Apex? | 2,518 | 30 | 0.8% |
| Trek Coronary Dilatation Catheter | 2,204 | 3 | 1.1% |
| Maverick2 Monorail Ptca Catheter | 1,579 | 0 | 1.1% |
| Mini Trek Coronary Dilatation Catheter | 1,538 | 0 | 0.5% |
| Maverick? | 1,337 | 71 | 0.4% |
| Ptca Catheters | 1,269 | 0 | 0.4% |
| Quantum? Maverick? | 1,173 | 39 | 0.3% |
| Voyager Nc Coronary Dilatation Catheter | 747 | 0 | 0.5% |
| Euphora Rx | 529 | 43 | 1.7% |
| Voyager Rx Coronary Dilatation Catheter | 736 | 0 | 0.7% |
| Apex | 876 | 78 | 1.3% |
| Nc Traveler Coronary Dilatation Catheter | 504 | 0 | 0.6% |
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 Apex Monorail reports
How many FDA reports name Apex Monorail?
603 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 (84.6%), injury (13.3%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
balloon rupture (37.5%), material rupture (28.4%), difficult to remove (4.5%), shaft break (3.3%) and break (2.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Apex Monorail 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.