Devices › Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation
Device brand name · Percutaneous cardiac abl cath for treatmt of afib w irreversible electroporation
VARIPULSE Bi-Directional Catheter: medical device reports filed with FDA
351 reports name it, 2025–2026. Manufacturer given most often on reports: Biosense Webster. Product code QZI.
- 351
- device reports naming the brand
- 0% of all MAUDE reports · about 235 a year
- 309
- reports, 12 months to August 2026
- 42 in the 12 months before
- 21.9%
- classified as malfunction
- 52.5% across the product code
- 1.7%
- classified as death, as reported
- 6 reports · not verified by FDA
351 medical device reports received by FDA name the brand "VARIPULSE Bi-Directional Catheter" (percutaneous cardiac abl cath for treatmt of afib w irreversible electroporation); the manufacturer given most often on reports is Biosense Webster; received from January 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
309 reports arrived in the 12 months to August 2026, up 636% from 42 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 (76.4%), malfunction (21.9%) and death (1.7%); 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 patient device interaction problem (76.9%), obstruction of flow (4.8%) and mechanical jam (4.6%). The patient problems coded most often are stroke/cva, cardiac tamponade and cardiac arrest. 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.
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 |
|---|---|---|---|
| Patient device interaction problem | 270 | 76.9% | 5% |
| Obstruction of flow | 17 | 4.8% | 0.3% |
| Mechanical jam | 16 | 4.6% | 0.3% |
| Coagulation in device or device ingredient | 6 | 1.7% | 0.9% |
| Positioning problem | 5 | 1.4% | 0.2% |
| High readingsreadings were too high | 4 | 1.1% | 0.2% |
| Breakthe device broke | 3 | 0.9% | 1.7% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 0.9% | 0.7% |
| Delivered as unsterile product | 3 | 0.9% | 0.3% |
| Failure to sense | 3 | 0.9% | 0% |
| Improper or incorrect procedure or method | 3 | 0.9% | 0.1% |
| Unintended movement | 3 | 0.9% | 0.1% |
| Electrical shorting | 2 | 0.6% | 0.1% |
| Low readingsreadings were too low | 2 | 0.6% | 0% |
| Tear, rip or hole in device packaging | 2 | 0.6% | 0.4% |
| Activation failure | 1 | 0.3% | 0.3% |
| Air/gas in device | 1 | 0.3% | 1.4% |
| Device contamination with body fluid | 1 | 0.3% | 0.1% |
| Device sensing problem | 1 | 0.3% | 0.1% |
| Display or visual feedback problem | 1 | 0.3% | 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 |
|---|---|---|
| Stroke/cva | 102 | 29.1% |
| Cardiac tamponade | 69 | 19.7% |
| Cardiac arrestthe heart stopped | 15 | 4.3% |
| Cardiac perforation | 14 | 4% |
| Transient ischemic attack | 10 | 2.8% |
| Ischemic heart disease | 8 | 2.3% |
| Asystole | 7 | 2% |
| Respiratory failurethe lungs could not supply enough oxygen | 7 | 2% |
| Vasospasm | 7 | 2% |
| Heart block | 6 | 1.7% |
| Hemolysis | 5 | 1.4% |
| Ischemia stroke | 5 | 1.4% |
| Thrombosis/thrombus | 5 | 1.4% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 5 | 1.4% |
| Bradycardiaslow heart rate | 4 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | VARIPULSE Bi-Directional Catheter | Product code QZI | All MAUDE reports |
|---|---|---|---|
| Reports | 351 | 9,434 | 26,136,888 |
| Share of that pool | — | 3.7% | 0% |
| Classified as death, per 1,000 reports | 17 | 23 | 9 |
| Classified as injury | 76.4% | 44.9% | 36.2% |
| Classified as malfunction | 21.9% | 52.5% | 62.3% |
| Filed by the manufacturer | 93.2% | 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, 31mm | 863 | 85 | 1.4% |
| FARAWAVE Pulsed Field Ablation Catheter | 551 | 109 | 3.1% |
| FARAWAVE Nav | 527 | 404 | 3.2% |
| 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 VARIPULSE Bi-Directional Catheter reports
How many FDA reports name VARIPULSE Bi-Directional Catheter?
351 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 309 in the latest 12 months.
What kinds of events are reported?
injury (76.4%), malfunction (21.9%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (76.9%), obstruction of flow (4.8%), mechanical jam (4.6%), coagulation in device or device ingredient (1.7%) and positioning problem (1.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.2%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that VARIPULSE Bi-Directional Catheter 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.