Devices › Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Device brand name · Catheter percutaneous cardiac ablation for treatment of atrial fibrillation
Polarxfit: medical device reports filed with FDA
235 reports name it, 2023–2026. Manufacturer given most often on reports: Boston Scientific De Costa Rica. Product code OAE.
- 235
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 17
- reports, 12 months to August 2026
- 59 in the 12 months before
- 65.1%
- classified as malfunction
- 49% across the product code
- 1.7%
- classified as death, as reported
- 4 reports · not verified by FDA
235 medical device reports received by FDA name the brand "Polarxfit" (catheter percutaneous cardiac ablation for treatment of atrial fibrillation); the manufacturer given most often on reports is Boston Scientific De Costa Rica; received from August 2023 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
17 reports arrived in the 12 months to August 2026, down 71% from 59 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 (65.1%), injury (33.2%) and death (1.7%); across all catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation reports (product code OAE) death is recorded in 3% and malfunction in 49%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with body fluid (46.4%), temperature problem (4.3%) and unintended deflation (3.8%). The patient problems coded most often are nerve damage, cardiac tamponade and appropriate clinical signs, symptoms and conditions term/code not available. 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 11,466 reports carrying product code OAE. 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 |
|---|---|---|---|
| Device contamination with body fluid | 109 | 46.4% | 5.8% |
| Temperature problem | 10 | 4.3% | 1.3% |
| Unintended deflation | 9 | 3.8% | 0.1% |
| Difficult to removethe device was hard to remove | 7 | 3% | 0.1% |
| Improper flow or infusion | 5 | 2.1% | 0.9% |
| Increase in pressure | 5 | 2.1% | 0.3% |
| Off-label use | 5 | 2.1% | 0.3% |
| Infusion or flow problema problem with flow or infusion | 4 | 1.7% | 0.5% |
| Material integrity problema problem with the device material | 4 | 1.7% | 6.2% |
| Air/gas in device | 3 | 1.3% | 0% |
| Burst container or vessel | 2 | 0.9% | 0% |
| Device-device incompatibility | 2 | 0.9% | 0% |
| Failure to deflate | 2 | 0.9% | 0% |
| Nonstandard device | 2 | 0.9% | 0.1% |
| Defective devicethe device was defective | 1 | 0.4% | 0.2% |
| Detachment of device or device componentpart of the device came off | 1 | 0.4% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.4% | 0.3% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.4% | 0.1% |
| Insufficient cooling | 1 | 0.4% | 1.3% |
| Leak/splashthe device leaked | 1 | 0.4% | 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 |
|---|---|---|
| Nerve damage | 49 | 20.9% |
| Cardiac tamponade | 8 | 3.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 7 | 3% |
| Low blood pressure/ hypotension | 6 | 2.6% |
| Non specific ekg/ECG changes | 6 | 2.6% |
| Gastritisinflamed stomach lining | 3 | 1.3% |
| Pericardial effusionfluid around the heart | 3 | 1.3% |
| Arrhythmia | 2 | 0.9% |
| Cardiac arrestthe heart stopped | 2 | 0.9% |
| Chest painchest pain | 2 | 0.9% |
| Hemoptysis | 2 | 0.9% |
| Stroke/cva | 2 | 0.9% |
| Anemialow red blood cells | 1 | 0.4% |
| Balance problems | 1 | 0.4% |
| Bradycardiaslow heart rate | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Polarxfit | Product code OAE | All MAUDE reports |
|---|---|---|---|
| Reports | 235 | 11,466 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 17 | 30 | 9 |
| Classified as injury | 33.2% | 47.9% | 36.2% |
| Classified as malfunction | 65.1% | 49% | 62.3% |
| Filed by the manufacturer | 100% | 97.6% | 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 OAE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Arctic Front Advance Cardiac Cryoablation Catheter | 2,364 | 46 | 2.6% |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter | 1,727 | 152 | 2.5% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F | 1,088 | 38 | 2.4% |
| QDOT Micro | 1,169 | 390 | 3% |
| Tacticath Quartz Contact Force Ablation Catheter 75mm | 633 | 0 | 3.3% |
| Qdot Micro Catheter | 538 | 37 | 3.5% |
| TactiFlex Ablation Catheter, Sensor Enabled | 514 | 164 | 3.7% |
| IntellaNav StablePoint Open-Irrigated | 376 | 33 | 1.1% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled | 305 | 34 | 6.9% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve F-J | 219 | 6 | 2.7% |
| Tacticath Quartz Contact Force Ablation Catheter 65mm | 208 | 0 | 3.8% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve D | 188 | 11 | 1.6% |
| Heartlight | 206 | 0 | 1% |
| Tactisys Quartz Ablation System | 155 | 16 | 0% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve F | 151 | 4 | 4% |
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 Polarxfit reports
How many FDA reports name Polarxfit?
235 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 17 in the latest 12 months.
What kinds of events are reported?
malfunction (65.1%), injury (33.2%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with body fluid (46.4%), temperature problem (4.3%), unintended deflation (3.8%), difficult to remove (3%) and improper flow or infusion (2.1%). 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 Polarxfit 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.