Devices › Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation
Device brand name · Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with
PulseSelect: medical device reports filed with FDA
2,146 reports name it, 2024–2026. Manufacturer given most often on reports: Medtronic Cryocath. Product code QZI.
- 2,146
- device reports naming the brand
- 0% of all MAUDE reports · about 921 a year
- 1,266
- reports, 12 months to August 2026
- 805 in the 12 months before
- 65%
- classified as malfunction
- 52.5% across the product code
- 0.8%
- classified as death, as reported
- 18 reports · not verified by FDA
2,146 medical device reports received by FDA name the brand "PulseSelect" (percutaneous cardiac ablation catheter for treatment of atrial fibrillation with); the manufacturer given most often on reports is Medtronic Cryocath; received from March 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,266 reports arrived in the 12 months to August 2026, up 57% from 805 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%), injury (34.2%) and death (0.8%); 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 material deformation (33.1%), material twisted/bent (21.8%) and device contamination with chemical or other material (8.5%). The patient problems coded most often are syncope/fainting, low blood pressure/ hypotension and bradycardia. 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 |
|---|---|---|---|
| Material deformation | 710 | 33.1% | 8.4% |
| Material twisted/bent | 467 | 21.8% | 7.7% |
| Device contamination with chemical or other material | 182 | 8.5% | 5.2% |
| Breakthe device broke | 156 | 7.3% | 1.7% |
| Detachment of device or device componentpart of the device came off | 144 | 6.7% | 4.2% |
| Material integrity problema problem with the device material | 121 | 5.6% | 3.3% |
| Thermal decomposition of device | 57 | 2.7% | 0.7% |
| Coagulation in device or device ingredient | 34 | 1.6% | 0.9% |
| Clumping in device or device ingredient | 18 | 0.8% | 0.2% |
| Deformation due to compressive stress | 10 | 0.5% | 0.2% |
| Entrapment of device | 10 | 0.5% | 11% |
| Contamination | 6 | 0.3% | 3.3% |
| Off-label use | 6 | 0.3% | 6.8% |
| Unintended movement | 6 | 0.3% | 0.1% |
| Gas/air leak | 5 | 0.2% | 0.1% |
| Material split, cut or torn | 5 | 0.2% | 0.1% |
| Contamination /decontamination problem | 4 | 0.2% | 0.1% |
| Delivered as unsterile product | 4 | 0.2% | 0.3% |
| Fracturea broken bone | 4 | 0.2% | 0.1% |
| Separation problem | 4 | 0.2% | 0% |
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 |
|---|---|---|
| Syncope/fainting | 169 | 7.9% |
| Low blood pressure/ hypotension | 119 | 5.5% |
| Bradycardiaslow heart rate | 101 | 4.7% |
| Pericardial effusionfluid around the heart | 101 | 4.7% |
| Heart block | 84 | 3.9% |
| Cardiac tamponade | 76 | 3.5% |
| Stroke/cva | 67 | 3.1% |
| Atrial fibrillationan irregular heart rhythm | 56 | 2.6% |
| Cardiac arrestthe heart stopped | 53 | 2.5% |
| Non specific ekg/ECG changes | 46 | 2.1% |
| Tachycardiafast heart rate | 46 | 2.1% |
| Hemorrhage/blood loss/bleeding | 36 | 1.7% |
| Nerve damage | 32 | 1.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 30 | 1.4% |
| Arrhythmia | 25 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PulseSelect | Product code QZI | All MAUDE reports |
|---|---|---|---|
| Reports | 2,146 | 9,434 | 26,136,888 |
| Share of that pool | — | 22.7% | 0% |
| Classified as death, per 1,000 reports | 8 | 23 | 9 |
| Classified as injury | 34.2% | 44.9% | 36.2% |
| Classified as malfunction | 65% | 52.5% | 62.3% |
| Filed by the manufacturer | 99.6% | 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% |
| 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% |
| 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 PulseSelect reports
How many FDA reports name PulseSelect?
2,146 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,266 in the latest 12 months.
What kinds of events are reported?
malfunction (65%), injury (34.2%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (33.1%), material twisted/bent (21.8%), device contamination with chemical or other material (8.5%), break (7.3%) and detachment of device or device component (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) 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 PulseSelect 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.