Devices › Catheters, transluminal coronary angioplasty, percutaneous
Device brand name · Coronary dilatation catheter
Powersail Coronary Dilatation Catheter: medical device reports filed with FDA
188 reports name it, 2001–2011. Manufacturer given most often on reports: Guidant Vascular Intervention. Product code LOX.
- 188
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 78.2%
- classified as malfunction
- 85.5% across the product code
- 1.1%
- classified as death, as reported
- 2 reports · not verified by FDA
188 medical device reports received by FDA name the brand "Powersail Coronary Dilatation Catheter" (coronary dilatation catheter); the manufacturer given most often on reports is Guidant Vascular Intervention; received from May 2001 to May 2011. 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 (78.2%), injury (20.2%) and death (1.1%); 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 source, detachment from (33.5%), balloon rupture (19.7%) and material separation (19.7%). The patient problems coded most often are foreign body, removal of, therapy/non-surgical treatment, additional and no patient involvement. 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 Powersail Coronary Dilatation Catheter was received in the five years to August 2026; the latest was received in May 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 |
|---|---|---|---|
| Source, detachment from | 63 | 33.5% | 0.6% |
| Balloon rupture | 37 | 19.7% | 10.2% |
| Material separation | 37 | 19.7% | 3% |
| Difficult to removethe device was hard to remove | 26 | 13.8% | 11.3% |
| Tip breakage | 22 | 11.7% | 0.5% |
| Difficult to insertthe device was hard to insert | 16 | 8.5% | 1.2% |
| Detachment of device component | 14 | 7.4% | 4.3% |
| Failure to advance | 12 | 6.4% | 5.4% |
| Physical resistance | 12 | 6.4% | 2.3% |
| Sticking | 10 | 5.3% | 0.7% |
| Shaft break | 8 | 4.3% | 1.9% |
| Inflation problem | 7 | 3.7% | 5.6% |
| Replace | 6 | 3.2% | 4.8% |
| Deflation problem | 5 | 2.7% | 5.9% |
| Leak/splashthe device leaked | 5 | 2.7% | 2.5% |
| Breakthe device broke | 4 | 2.1% | 7.4% |
| Difficult to position | 4 | 2.1% | 1.2% |
| Balloon burst | 3 | 1.6% | 1.2% |
| Device, removal of (non-implant) | 3 | 1.6% | 2.2% |
| Air leak | 2 | 1.1% | 0.1% |
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, removal of | 17 | 9% |
| Therapy/non-surgical treatment, additional | 14 | 7.4% |
| No patient involvement | 8 | 4.3% |
| Surgical procedure | 7 | 3.7% |
| Hospitalization required | 6 | 3.2% |
| Surgical procedure, additional | 6 | 3.2% |
| Intimal dissection | 5 | 2.7% |
| Deaththe patient died; cause not stated by this term | 3 | 1.6% |
| Angina | 2 | 1.1% |
| Arrhythmia | 2 | 1.1% |
| Nonresorbable materials, unretrieved in body | 2 | 1.1% |
| Air embolism | 1 | 0.5% |
| Aneurysm | 1 | 0.5% |
| Bleeding | 1 | 0.5% |
| Cardiac arrestthe heart stopped | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Powersail Coronary Dilatation Catheter | Product code LOX | All MAUDE reports |
|---|---|---|---|
| Reports | 188 | 43,618 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 11 | 13 | 9 |
| Classified as injury | 20.2% | 12.9% | 36.2% |
| Classified as malfunction | 78.2% | 85.5% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Apex Monorail | 603 | 0 | 1.7% |
| Euphora Rx | 529 | 43 | 1.7% |
| Voyager Rx Coronary Dilatation Catheter | 736 | 0 | 0.7% |
| Apex | 876 | 78 | 1.3% |
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 Powersail Coronary Dilatation Catheter reports
How many FDA reports name Powersail Coronary Dilatation Catheter?
188 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 (78.2%), injury (20.2%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
source, detachment from (33.5%), balloon rupture (19.7%), material separation (19.7%), difficult to remove (13.8%) and tip breakage (11.7%). 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 Powersail Coronary Dilatation 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.