Device brand name · Catheter steerable
FlexCath Advance Steerable Sheath: medical device reports filed with FDA
2,941 reports name it, 2013–2026. Manufacturer given most often on reports: Medtronic Cryocath. Product code DRA.
- 2,941
- device reports naming the brand
- 0% of all MAUDE reports · about 221 a year
- 58
- reports, 12 months to August 2026
- 149 in the 12 months before
- 45.4%
- classified as malfunction
- 61.9% across the product code
- 3.5%
- classified as death, as reported
- 103 reports · not verified by FDA
FDA's MAUDE database holds 2,941 reports that name the brand "FlexCath Advance Steerable Sheath" (catheter steerable), received between March 2013 and August 2026; the manufacturer given most often on reports is Medtronic Cryocath. Spellings of one product vary from report to report.
58 reports arrived in the 12 months to August 2026, down 61% from 149 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 (51.1%), malfunction (45.4%) and death (3.5%); 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 material twisted/bent (12.5%), gas/air leak (11.7%) and air leak (11.6%). The patient problems coded most often are pericardial effusion, cardiac tamponade and low blood pressure/ hypotension. 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 |
|---|---|---|---|
| Material twisted/bent | 369 | 12.5% | 4.7% |
| Gas/air leak | 345 | 11.7% | 4.3% |
| Air leak | 340 | 11.6% | 2.9% |
| Fluid/blood leak | 215 | 7.3% | 4.3% |
| Material integrity problema problem with the device material | 110 | 3.7% | 3.7% |
| Insufficient device problem information | 95 | 3.2% | 1% |
| Compatibility problem | 88 | 3% | 0.7% |
| Kinkedthe tube or line kinked | 70 | 2.4% | 0.6% |
| Material deformation | 54 | 1.8% | 0.7% |
| Detachment of device component | 44 | 1.5% | 0.5% |
| Device handling problem | 39 | 1.3% | 0.3% |
| Leak/splashthe device leaked | 34 | 1.2% | 16.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 25 | 0.9% | 0.8% |
| Peeled/delaminated | 24 | 0.8% | 0.3% |
| Mechanical problema mechanical problem | 16 | 0.5% | 0.9% |
| Device contamination with body fluid | 15 | 0.5% | 3% |
| Aspiration issue | 13 | 0.4% | 0.2% |
| Device contamination with chemical or other material | 10 | 0.3% | 0.6% |
| Delivered as unsterile product | 8 | 0.3% | 0.1% |
| Difficult to insertthe device was hard to insert | 7 | 0.2% | 1.3% |
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 | 492 | 16.7% |
| Cardiac tamponade | 443 | 15.1% |
| Low blood pressure/ hypotension | 381 | 13% |
| Hematomaa collection of blood under the skin or in tissue | 166 | 5.6% |
| Pseudoaneurysm | 144 | 4.9% |
| St segment elevation | 134 | 4.6% |
| Cardiac perforation | 109 | 3.7% |
| Air embolism | 103 | 3.5% |
| Fistula | 100 | 3.4% |
| Hemorrhage/blood loss/bleeding | 83 | 2.8% |
| Stroke/cva | 66 | 2.2% |
| Cardiac arrestthe heart stopped | 56 | 1.9% |
| Deaththe patient died; cause not stated by this term | 49 | 1.7% |
| Non specific ekg/ECG changes | 48 | 1.6% |
| Chest painchest pain | 41 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | FlexCath Advance Steerable Sheath | Product code DRA | All MAUDE reports |
|---|---|---|---|
| Reports | 2,941 | 13,946 | 26,136,888 |
| Share of that pool | — | 21.1% | 0% |
| Classified as death, per 1,000 reports | 35 | 18 | 9 |
| Classified as injury | 51.1% | 36.2% | 36.2% |
| Classified as malfunction | 45.4% | 61.9% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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% |
| FARADRIVE Steerable Sheath | 192 | 102 | 4.2% |
| 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 FlexCath Advance Steerable Sheath reports
How many FDA reports name FlexCath Advance Steerable Sheath?
2,941 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 58 in the latest 12 months.
What kinds of events are reported?
injury (51.1%), malfunction (45.4%) and death (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material twisted/bent (12.5%), gas/air leak (11.7%), air leak (11.6%), fluid/blood leak (7.3%) and material integrity problem (3.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that FlexCath Advance 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.