Device brand name · Catheter electrode recording or probe electrode recording
Polarsheath: medical device reports filed with FDA
418 reports name it, 2020–2026. Manufacturer given most often on reports: Boston Scientific De Costa Rica. Product code DRA.
- 418
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 12
- reports, 12 months to August 2026
- 47 in the 12 months before
- 68.9%
- classified as malfunction
- 61.9% across the product code
- 1.2%
- classified as death, as reported
- 5 reports · not verified by FDA
418 medical device reports received by FDA name the brand "Polarsheath" (catheter electrode recording or probe electrode recording); the manufacturer given most often on reports is Boston Scientific De Costa Rica; received from July 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
12 reports arrived in the 12 months to August 2026, down 74% from 47 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 (68.9%), injury (29.9%) and death (1.2%); 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 leak/splash (41.9%), air/gas in device (17.9%) and material integrity problem (7.7%). The patient problems coded most often are non specific ekg/ECG changes, air embolism 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 175 | 41.9% | 16.7% |
| Air/gas in device | 75 | 17.9% | 23.7% |
| Material integrity problema problem with the device material | 32 | 7.7% | 3.7% |
| Device contamination with body fluid | 29 | 6.9% | 3% |
| Difficult to flush | 15 | 3.6% | 0.5% |
| Detachment of device or device componentpart of the device came off | 9 | 2.2% | 0.3% |
| Mechanics altered | 5 | 1.2% | 0.1% |
| Packaging problem | 5 | 1.2% | 0.1% |
| Device-device incompatibility | 4 | 1% | 0.6% |
| Difficult to removethe device was hard to remove | 4 | 1% | 1.1% |
| Device contamination with chemical or other material | 3 | 0.7% | 0.6% |
| Material deformation | 3 | 0.7% | 0.7% |
| Human-device interface problem | 2 | 0.5% | 0.1% |
| Positioning problem | 2 | 0.5% | 0.3% |
| Unsealed device packaging | 2 | 0.5% | 0.1% |
| Connection problema connection problem | 1 | 0.2% | 0% |
| Defective devicethe device was defective | 1 | 0.2% | 0% |
| Device contaminated during manufacture or shipping | 1 | 0.2% | 0.1% |
| Difficult to advance | 1 | 0.2% | 1.8% |
| Improper flow or infusion | 1 | 0.2% | 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 |
|---|---|---|
| Non specific ekg/ECG changes | 46 | 11% |
| Air embolism | 25 | 6% |
| Pericardial effusionfluid around the heart | 18 | 4.3% |
| Cardiac tamponade | 14 | 3.3% |
| Hematomaa collection of blood under the skin or in tissue | 14 | 3.3% |
| Low blood pressure/ hypotension | 10 | 2.4% |
| Hemorrhage/blood loss/bleeding | 7 | 1.7% |
| Chest painchest pain | 6 | 1.4% |
| Dyspneashortness of breath | 5 | 1.2% |
| St segment elevation | 5 | 1.2% |
| Cardiac perforation | 4 | 1% |
| Heart block | 4 | 1% |
| Palpitationsawareness of the heartbeat | 4 | 1% |
| Perforation of vessels | 4 | 1% |
| Atrial flutter | 3 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Polarsheath | Product code DRA | All MAUDE reports |
|---|---|---|---|
| Reports | 418 | 13,946 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 12 | 18 | 9 |
| Classified as injury | 29.9% | 36.2% | 36.2% |
| Classified as malfunction | 68.9% | 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% |
| 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% |
| 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 Polarsheath reports
How many FDA reports name Polarsheath?
418 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.
What kinds of events are reported?
malfunction (68.9%), injury (29.9%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (41.9%), air/gas in device (17.9%), material integrity problem (7.7%), device contamination with body fluid (6.9%) and difficult to flush (3.6%). 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 Polarsheath 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.