Devices › Catheter, percutaneous
Device brand name · System appendage closure left atrial
WATCHMAN TruSeal Access System: medical device reports filed with FDA
716 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code DQY.
- 716
- device reports naming the brand
- 0% of all MAUDE reports · about 90 a year
- 50
- reports, 12 months to August 2026
- 33 in the 12 months before
- 24.9%
- classified as malfunction
- 74.7% across the product code
- 8%
- classified as death, as reported
- 57 reports · not verified by FDA
716 medical device reports received by FDA name the brand "WATCHMAN TruSeal Access System" (system appendage closure left atrial); the manufacturer given most often on reports is Boston Scientific; received from August 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
50 reports arrived in the 12 months to August 2026, up 52% from 33 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 injury (67.2%), malfunction (24.9%) and death (8%); across all catheter, percutaneous reports (product code DQY) death is recorded in 2.2% and malfunction in 74.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material deformation (13.7%), material integrity problem (6.3%) and difficult to remove (4.2%). The patient problems coded most often are pericardial effusion, hematoma and thrombosis/thrombus. 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 41,793 reports carrying product code DQY. 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 deformation | 98 | 13.7% | 5% |
| Material integrity problema problem with the device material | 45 | 6.3% | 2.1% |
| Difficult to removethe device was hard to remove | 30 | 4.2% | 4.1% |
| Deformation due to compressive stress | 27 | 3.8% | 2.3% |
| Gas/air leak | 9 | 1.3% | 0.2% |
| Air/gas in device | 8 | 1.1% | 0.4% |
| Difficult to advance | 7 | 1% | 1.8% |
| Leak/splashthe device leaked | 7 | 1% | 4.6% |
| Detachment of device or device componentpart of the device came off | 6 | 0.8% | 4.6% |
| Device-device incompatibility | 5 | 0.7% | 0.6% |
| Difficult to insertthe device was hard to insert | 5 | 0.7% | 1.2% |
| Device contamination with chemical or other material | 4 | 0.6% | 0.4% |
| Nonstandard device | 3 | 0.4% | 0.2% |
| Physical resistance/sticking | 3 | 0.4% | 2.9% |
| Positioning problem | 2 | 0.3% | 0.3% |
| Activation, positioning or separation problem | 1 | 0.1% | 0.1% |
| Device dislodged or dislocated | 1 | 0.1% | 0.5% |
| Difficult to flush | 1 | 0.1% | 0.1% |
| Failure to advance | 1 | 0.1% | 2.6% |
| Fitting problem | 1 | 0.1% | 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 |
|---|---|---|
| Pericardial effusionfluid around the heart | 131 | 18.3% |
| Hematomaa collection of blood under the skin or in tissue | 74 | 10.3% |
| Thrombosis/thrombus | 69 | 9.6% |
| Cardiac perforation | 62 | 8.7% |
| Hemorrhage/blood loss/bleeding | 48 | 6.7% |
| Low blood pressure/ hypotension | 47 | 6.6% |
| Cardiac tamponade | 45 | 6.3% |
| Perforation of vessels | 38 | 5.3% |
| Air embolism | 35 | 4.9% |
| Pseudoaneurysm | 32 | 4.5% |
| Thrombosis | 23 | 3.2% |
| Cardiac arrestthe heart stopped | 21 | 2.9% |
| Retroperitoneal hemorrhage | 19 | 2.7% |
| Non specific ekg/ECG changes | 15 | 2.1% |
| Blood loss | 10 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WATCHMAN TruSeal Access System | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 716 | 41,793 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 80 | 22 | 9 |
| Classified as injury | 67.2% | 22.7% | 36.2% |
| Classified as malfunction | 24.9% | 74.7% | 62.3% |
| Filed by the manufacturer | 99.6% | 97.4% | 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 DQY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sterling | 4,963 | 300 | 0.1% |
| Deflect | 1,021 | 247 | 0.1% |
| Guidezilla | 1,018 | 0 | 0% |
| Lantern Delivery Microcatheter | 887 | 19 | 0% |
| WATCHMAN FXD Curve Access System | 973 | 198 | 9.6% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Coyote? | 1,767 | 122 | 0.1% |
| Advance 35 Lp Low Profile Balloon Catheter | 572 | 15 | 0.5% |
| Conquest Pta Dilatation Catheter | 505 | 0 | 0.2% |
| Sterling Balloon Dilatation Catheter | 488 | 0 | 0.4% |
| React catheter | 516 | 41 | 18.4% |
| Conquest Pta Balloon Dilatation Catheter | 510 | 0 | 0.2% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Neuron Max 6f 088 Long Sheath | 389 | 0 | 0.5% |
| WATCHMAN TruSteer? Access System | 401 | 260 | 9.2% |
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 WATCHMAN TruSeal Access System reports
How many FDA reports name WATCHMAN TruSeal Access System?
716 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
injury (67.2%), malfunction (24.9%) and death (8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (13.7%), material integrity problem (6.3%), difficult to remove (4.2%), deformation due to compressive stress (3.8%) and gas/air leak (1.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that WATCHMAN TruSeal Access System 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.