Device brand name · Catheter steerable
FARADRIVE Steerable Sheath: medical device reports filed with FDA
192 reports name it, 2024–2026. Manufacturer given most often on reports: Boston Scientific. Product code DRA.
- 192
- device reports naming the brand
- 0% of all MAUDE reports · about 82 a year
- 102
- reports, 12 months to August 2026
- 67 in the 12 months before
- 33.3%
- classified as malfunction
- 61.9% across the product code
- 4.2%
- classified as death, as reported
- 8 reports · not verified by FDA
FDA's MAUDE database holds 192 reports that name the brand "FARADRIVE Steerable Sheath" (catheter steerable), received between March 2024 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
102 reports arrived in the 12 months to August 2026, up 52% from 67 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 (62.5%), malfunction (33.3%) and death (4.2%); across all catheter, steerable reports (product code DRA) death is recorded in 1.8% and malfunction in 61.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are air/gas in device (20.3%), difficult to advance (8.9%) and leak/splash (5.2%). The patient problems coded most often are low blood pressure/ hypotension, hemorrhage/blood loss/bleeding and pericardial effusion. 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 13,946 reports carrying product code DRA. 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 |
|---|---|---|---|
| Air/gas in device | 39 | 20.3% | 23.7% |
| Difficult to advance | 17 | 8.9% | 1.8% |
| Leak/splashthe device leaked | 10 | 5.2% | 16.7% |
| Device contamination with body fluid | 7 | 3.6% | 3% |
| Device-device incompatibility | 5 | 2.6% | 0.6% |
| Material integrity problema problem with the device material | 4 | 2.1% | 3.7% |
| Suction problem | 4 | 2.1% | 1.1% |
| Difficult or delayed positioning | 3 | 1.6% | 0.5% |
| Difficult to insertthe device was hard to insert | 3 | 1.6% | 1.3% |
| Difficult to removethe device was hard to remove | 3 | 1.6% | 1.1% |
| Fluid/blood leak | 3 | 1.6% | 4.3% |
| Off-label use | 3 | 1.6% | 0.4% |
| Device dislodged or dislocated | 2 | 1% | 0.1% |
| Restricted flow rate | 2 | 1% | 0.1% |
| Deformation due to compressive stress | 1 | 0.5% | 1.4% |
| Device contamination with chemical or other material | 1 | 0.5% | 0.6% |
| Device sensing problem | 1 | 0.5% | 0% |
| Difficult to flush | 1 | 0.5% | 0.5% |
| Fitting problem | 1 | 0.5% | 0% |
| Mechanical problema mechanical problem | 1 | 0.5% | 0.9% |
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 |
|---|---|---|
| Low blood pressure/ hypotension | 29 | 15.1% |
| Hemorrhage/blood loss/bleeding | 25 | 13% |
| Pericardial effusionfluid around the heart | 23 | 12% |
| Hematomaa collection of blood under the skin or in tissue | 17 | 8.9% |
| Non specific ekg/ECG changes | 15 | 7.8% |
| Air embolism | 13 | 6.8% |
| Cardiac perforation | 10 | 5.2% |
| Cardiac tamponade | 10 | 5.2% |
| Perforation of vessels | 9 | 4.7% |
| Pseudoaneurysm | 9 | 4.7% |
| Cardiac arrestthe heart stopped | 8 | 4.2% |
| Thrombosis/thrombus | 6 | 3.1% |
| Stroke/cva | 5 | 2.6% |
| Tachycardiafast heart rate | 5 | 2.6% |
| Fistula | 4 | 2.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | FARADRIVE Steerable Sheath | Product code DRA | All MAUDE reports |
|---|---|---|---|
| Reports | 192 | 13,946 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 42 | 18 | 9 |
| Classified as injury | 62.5% | 36.2% | 36.2% |
| Classified as malfunction | 33.3% | 61.9% | 62.3% |
| Filed by the manufacturer | 97.4% | 99.3% | 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 DRA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| FARADRIVE Steerable Sheath Clear | 4,154 | 1,559 | 0.5% |
| FlexCath Advance Steerable Sheath | 2,941 | 58 | 3.5% |
| Mitraclip System Steerable Guide Catheter | 1,528 | 16 | 3% |
| G4 Steerable Guiding Catheter | 896 | 0 | 1.6% |
| FlexCath Contour Steerable Sheath | 871 | 399 | 1.5% |
| Faradrive | 792 | 192 | 0.9% |
| Mitraclip | 3,357 | 1,161 | 2% |
| Polarsheath | 418 | 12 | 1.2% |
| Flexcath Steerable Sheath | 365 | 0 | 0.3% |
| Steerable Guide Catheter | 336 | 33 | 1.2% |
| G4 Steerable Guiding Catheter Ce | 262 | 2 | 1.1% |
| Mitraclip G4 Steerable Guide Catheter Mdr | 191 | 0 | 1.6% |
| Heartlight | 206 | 0 | 1% |
| Artisan? | 934 | 127 | 0.6% |
| Arctic Front Advance Cardiac Cryoablation Catheter | 2,364 | 46 | 2.6% |
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 FARADRIVE Steerable Sheath reports
How many FDA reports name FARADRIVE Steerable Sheath?
192 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 102 in the latest 12 months.
What kinds of events are reported?
injury (62.5%), malfunction (33.3%) and death (4.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
air/gas in device (20.3%), difficult to advance (8.9%), leak/splash (5.2%), device contamination with body fluid (3.6%) and device-device incompatibility (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.4%) and voluntary reports (2.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that FARADRIVE Steerable Sheath 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.