Devices › Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation
Device brand name · Cardiac irreversible electroporation system catheter
FARAWAVE Pulsed Field Ablation Catheter, 31mm: medical device reports filed with FDA
863 reports name it, 2024–2026. Manufacturer given most often on reports: Boston Scientific. Product code QZI.
- 863
- device reports naming the brand
- 0% of all MAUDE reports · about 358 a year
- 85
- reports, 12 months to August 2026
- 406 in the 12 months before
- 69.9%
- classified as malfunction
- 52.5% across the product code
- 1.4%
- classified as death, as reported
- 12 reports · not verified by FDA
863 medical device reports received by FDA name the brand "FARAWAVE Pulsed Field Ablation Catheter, 31mm" (cardiac irreversible electroporation system catheter); the manufacturer given most often on reports is Boston Scientific; received from February 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
85 reports arrived in the 12 months to August 2026, down 79% from 406 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 (69.9%), injury (28.7%) and death (1.4%); across all percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation reports (product code QZI) death is recorded in 2.3% and malfunction in 52.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are entrapment of device (27.8%), off-label use (10.8%) and detachment of device or device component (10.1%). The patient problems coded most often are pericardial effusion, low blood pressure/ hypotension and cardiac tamponade. 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 9,434 reports carrying product code QZI. 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 |
|---|---|---|---|
| Entrapment of device | 240 | 27.8% | 11% |
| Off-label use | 93 | 10.8% | 6.8% |
| Detachment of device or device componentpart of the device came off | 87 | 10.1% | 4.2% |
| Improper flow or infusion | 64 | 7.4% | 2.3% |
| Fluid/blood leak | 55 | 6.4% | 2.8% |
| Material twisted/bent | 52 | 6% | 7.7% |
| Positioning failure | 46 | 5.3% | 1.3% |
| Material integrity problema problem with the device material | 44 | 5.1% | 3.3% |
| Device contamination with chemical or other material | 37 | 4.3% | 5.2% |
| Difficult to flush | 34 | 3.9% | 1.5% |
| Activation, positioning or separation problem | 28 | 3.2% | 1.2% |
| Difficult to removethe device was hard to remove | 23 | 2.7% | 1.5% |
| Restricted flow rate | 20 | 2.3% | 1.2% |
| Contamination | 18 | 2.1% | 3.3% |
| Air/gas in device | 14 | 1.6% | 1.4% |
| Nonstandard device | 13 | 1.5% | 2.2% |
| Tear, rip or hole in device packaging | 8 | 0.9% | 0.4% |
| Device-device incompatibility | 7 | 0.8% | 0.8% |
| Material deformation | 5 | 0.6% | 8.4% |
| Difficult to advance | 4 | 0.5% | 0.7% |
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 | 59 | 6.8% |
| Low blood pressure/ hypotension | 53 | 6.1% |
| Cardiac tamponade | 28 | 3.2% |
| Non specific ekg/ECG changes | 28 | 3.2% |
| Syncope/fainting | 24 | 2.8% |
| Atrial fibrillationan irregular heart rhythm | 20 | 2.3% |
| Vasoconstriction | 18 | 2.1% |
| Cardiac perforation | 14 | 1.6% |
| Arrhythmia | 13 | 1.5% |
| Chest painchest pain | 13 | 1.5% |
| Atrial flutter | 12 | 1.4% |
| Cardiac arrestthe heart stopped | 12 | 1.4% |
| Stroke/cva | 12 | 1.4% |
| Bradycardiaslow heart rate | 10 | 1.2% |
| Dyspneashortness of breath | 10 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | FARAWAVE Pulsed Field Ablation Catheter, 31mm | Product code QZI | All MAUDE reports |
|---|---|---|---|
| Reports | 863 | 9,434 | 26,136,888 |
| Share of that pool | — | 9.1% | 0% |
| Classified as death, per 1,000 reports | 14 | 23 | 9 |
| Classified as injury | 28.7% | 44.9% | 36.2% |
| Classified as malfunction | 69.9% | 52.5% | 62.3% |
| Filed by the manufacturer | 100% | 95.7% | 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 QZI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Farawave | 2,590 | 1,409 | 3.6% |
| PulseSelect | 2,146 | 1,266 | 0.8% |
| Affera | 1,159 | 992 | 2.1% |
| FARAWAVE Pulsed Field Ablation Catheter | 551 | 109 | 3.1% |
| FARAWAVE Nav | 527 | 404 | 3.2% |
| VARIPULSE Bi-Directional Catheter | 351 | 309 | 1.7% |
| Farawave PFA Catheter | 189 | 183 | 3.2% |
| FARADRIVE Steerable Sheath Clear | 4,154 | 1,559 | 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 FARAWAVE Pulsed Field Ablation Catheter, 31mm reports
How many FDA reports name FARAWAVE Pulsed Field Ablation Catheter, 31mm?
863 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 85 in the latest 12 months.
What kinds of events are reported?
malfunction (69.9%), injury (28.7%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
entrapment of device (27.8%), off-label use (10.8%), detachment of device or device component (10.1%), improper flow or infusion (7.4%) and fluid/blood leak (6.4%). 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 FARAWAVE Pulsed Field Ablation Catheter, 31mm 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.