Devices › Catheter, percutaneous
Device brand name · Catheter percutaneous
WATCHMAN TruSteer? Access System: medical device reports filed with FDA
401 reports name it, 2024–2026. Manufacturer given most often on reports: Boston Scientific. Product code DQY.
- 401
- device reports naming the brand
- 0% of all MAUDE reports · about 185 a year
- 260
- reports, 12 months to August 2026
- 134 in the 12 months before
- 7.5%
- classified as malfunction
- 74.7% across the product code
- 9.2%
- classified as death, as reported
- 37 reports · not verified by FDA
401 medical device reports received by FDA name the brand "WATCHMAN TruSteer? Access System" (catheter percutaneous); the manufacturer given most often on reports is Boston Scientific; received from May 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
260 reports arrived in the 12 months to August 2026, up 94% from 134 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 (83.3%), death (9.2%) and malfunction (7.5%); 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 (3.5%), material integrity problem (3%) and deformation due to compressive stress (2%). The patient problems coded most often are pericardial effusion, low blood pressure/ hypotension 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 | 14 | 3.5% | 5% |
| Material integrity problema problem with the device material | 12 | 3% | 2.1% |
| Deformation due to compressive stress | 8 | 2% | 2.3% |
| Difficult to advance | 8 | 2% | 1.8% |
| Air/gas in device | 5 | 1.2% | 0.4% |
| Physical resistance/sticking | 5 | 1.2% | 2.9% |
| Nonstandard device | 3 | 0.7% | 0.2% |
| Device-device incompatibility | 2 | 0.5% | 0.6% |
| Connection problema connection problem | 1 | 0.2% | 0.3% |
| Defective devicethe device was defective | 1 | 0.2% | 0.2% |
| Device contaminated during manufacture or shipping | 1 | 0.2% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.2% | 0.4% |
| Difficult or delayed positioning | 1 | 0.2% | 0.1% |
| Difficult to flush | 1 | 0.2% | 0.1% |
| Fitting problem | 1 | 0.2% | 0.1% |
| Fluid/blood leak | 1 | 0.2% | 2.1% |
| Leak/splashthe device leaked | 1 | 0.2% | 4.6% |
| Retraction problem | 1 | 0.2% | 2.3% |
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 |
|---|---|---|
| Pericardial effusionfluid around the heart | 132 | 32.9% |
| Low blood pressure/ hypotension | 106 | 26.4% |
| Thrombosis/thrombus | 100 | 24.9% |
| Cardiac perforation | 63 | 15.7% |
| Cardiac tamponade | 52 | 13% |
| Air embolism | 35 | 8.7% |
| Non specific ekg/ECG changes | 33 | 8.2% |
| Hematomaa collection of blood under the skin or in tissue | 23 | 5.7% |
| Perforation of vessels | 20 | 5% |
| Cardiac arrestthe heart stopped | 19 | 4.7% |
| Hemorrhage/blood loss/bleeding | 18 | 4.5% |
| Stroke/cva | 11 | 2.7% |
| Arrhythmia | 9 | 2.2% |
| Retroperitoneal hemorrhage | 9 | 2.2% |
| Asystole | 7 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WATCHMAN TruSteer? Access System | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 401 | 41,793 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 92 | 22 | 9 |
| Classified as injury | 83.3% | 22.7% | 36.2% |
| Classified as malfunction | 7.5% | 74.7% | 62.3% |
| Filed by the manufacturer | 99.3% | 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% |
| WATCHMAN TruSeal Access System | 716 | 50 | 8% |
| 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% |
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 TruSteer? Access System reports
How many FDA reports name WATCHMAN TruSteer? Access System?
401 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 260 in the latest 12 months.
What kinds of events are reported?
injury (83.3%), death (9.2%) and malfunction (7.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (3.5%), material integrity problem (3%), deformation due to compressive stress (2%), difficult to advance (2%) and air/gas in device (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that WATCHMAN TruSteer? 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.