Devices › Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Device brand name · Coronary sinus catheter
Endoplege Coronary Sinus Catheter: medical device reports filed with FDA
254 reports name it, 2009–2012. Manufacturer given most often on reports: Edwards Lifesciences. Product code DWF.
- 254
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 85%
- classified as malfunction
- 73% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
254 medical device reports received by FDA name the brand "Endoplege Coronary Sinus Catheter" (coronary sinus catheter); the manufacturer given most often on reports is Edwards Lifesciences; received from May 2009 to November 2012. 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 (85%), injury (13.8%) and death (0.4%); across all catheter, cannula and tubing, vascular, cardiopulmonary bypass reports (product code DWF) death is recorded in 4.8% and malfunction in 73%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (21.3%), material rupture (11.8%) and balloon rupture (10.6%). The patient problems coded most often are no patient involvement, blood loss and surgery, prolonged. 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 Endoplege Coronary Sinus Catheter was received in the five years to August 2026; the latest was received in November 2012.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,314 reports carrying product code DWF. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 54 | 21.3% | 5.6% |
| Material rupture | 30 | 11.8% | 1.2% |
| Balloon rupture | 27 | 10.6% | 0.5% |
| Balloon burst | 24 | 9.4% | 0.3% |
| Balloon leak(s) | 24 | 9.4% | 0.5% |
| Fluid/blood leak | 14 | 5.5% | 9.1% |
| Material integrity problema problem with the device material | 12 | 4.7% | 1.2% |
| Other (for use when an appropriate device code cannot be identified) | 12 | 4.7% | 1.1% |
| Insufficient device problem information | 8 | 3.1% | 1.3% |
| Breakthe device broke | 6 | 2.4% | 4.3% |
| Balloon pinhole | 5 | 2% | 0.1% |
| Inadequate or insufficient training | 3 | 1.2% | 0% |
| Physical resistance | 3 | 1.2% | 0.3% |
| Pressure problem | 3 | 1.2% | 0.1% |
| Component missing | 2 | 0.8% | 1% |
| Defective devicethe device was defective | 2 | 0.8% | 0.4% |
| Detachment of device component | 2 | 0.8% | 2.1% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.8% | 0.1% |
| Device dislodged or dislocated | 2 | 0.8% | 0.3% |
| Device issuea problem with the device | 2 | 0.8% | 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 |
|---|---|---|
| No patient involvement | 17 | 6.7% |
| Blood loss | 4 | 1.6% |
| Surgery, prolonged | 4 | 1.6% |
| Needle stick/puncture | 2 | 0.8% |
| Perforation | 2 | 0.8% |
| Therapy/non-surgical treatment, additional | 2 | 0.8% |
| Cardiac arrestthe heart stopped | 1 | 0.4% |
| Cardiac perforation | 1 | 0.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.4% |
| Device embedded in tissue or plaque | 1 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.4% |
| Foreign body reaction | 1 | 0.4% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
| Low blood pressure/ hypotension | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endoplege Coronary Sinus Catheter | Product code DWF | All MAUDE reports |
|---|---|---|---|
| Reports | 254 | 6,314 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 4 | 48 | 9 |
| Classified as injury | 13.8% | 19.9% | 36.2% |
| Classified as malfunction | 85% | 73% | 62.3% |
| Filed by the manufacturer | 100% | 92.9% | 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 DWF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Custom Tubing Pack | 1,039 | 353 | 1.1% |
| EOPA Arterial Cannula | 262 | 100 | 1.1% |
| Cannula 77010 Art One Piece 10fr | 211 | 160 | 0% |
| Cardiovascular Procedure Kit | 553 | 0 | 1.3% |
| Endoclamp Aortic Catheter | 169 | 0 | 2.4% |
| Fogarty Arterial Embolectomy Catheter | 1,165 | 37 | 0.2% |
| Arctic Sun 5000 | 15,438 | 1,032 | 0% |
| Catheter | 244 | 9 | 3.7% |
| Tubing Set | 336 | 104 | 14% |
| Terumo Cardiovascular Procedure Kit | 150 | 24 | 0.7% |
| Terumo | 181 | 0 | 2.8% |
| Unknown ArcticGel Pads | 517 | 20 | 0% |
| Argyle | 871 | 60 | 1% |
| Artic Sun 5000 115v Na | 240 | 0 | 0% |
| Codman | 183 | 0 | 1.6% |
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 Endoplege Coronary Sinus Catheter reports
How many FDA reports name Endoplege Coronary Sinus Catheter?
254 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 (85%), injury (13.8%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (21.3%), material rupture (11.8%), balloon rupture (10.6%), balloon burst (9.4%) and balloon leak(s) (9.4%). 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 Endoplege Coronary Sinus 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.