Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation: medical device reports filed with FDA

9,434 reports carry this product code, 2024–2026; 9 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

9,434
reports with this product code: 0% of all MAUDE reports; 5,446
reports, 12 months to August 2026: 3,295 in the 12 months before; 52.5%
classified as malfunction: 62.3% across all reports; 2.3%
classified as death, as reported: 0.9% across all reports

Product code QZI is FDA's classification for "Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation" (unknown panel), a class 3 device. 9,434 medical device reports carry this product code, 0% of the MAUDE database, from February 2024 to August 2026.

5,446 reports arrived in the 12 months to August 2026, up 65% from 3,295 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 (52.5%), injury (44.9%) and death (2.3%). 9 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Farawave	2,585	1,409	3.6%	53.6%
PulseSelect	2,144	1,266	0.8%	65%
Affera	1,106	992	2.1%	32.4%
FARAWAVE Pulsed Field Ablation Catheter, 31mm	863	85	1.4%	69.9%
FARAWAVE Pulsed Field Ablation Catheter	550	109	3.1%	42.3%
FARAWAVE Nav	526	404	3.2%	49.5%
VARIPULSE Bi-Directional Catheter	351	309	1.7%	21.9%
Farawave PFA Catheter	189	183	3.2%	65.6%
FARADRIVE Steerable Sheath Clear	2	1,559	0.5%	89.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Boston Scientific	4,043	42.9%
Medtronic Cryocath	2,125	22.5%
Medtronic	782	8.3%
Biosense Webster	619	6.6%
Farapulse	512	5.4%
Medtronic Ireland	306	3.2%

Reports by month, five years

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

Death2.3%219

Injury44.9%4,239

Malfunction52.5%4,957

Other0.2%19

Not given0%0

Who filed

Manufacturer report95.7%9,032

Voluntary report2.8%264

User facility report0%0

Distributor report0%0

Not given1.5%138

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Entrapment of device	1,035	11%
Material deformation	794	8.4%
Material twisted/bent	725	7.7%
Off-label use	638	6.8%
Device contamination with chemical or other material	487	5.2%
Patient device interaction problem	473	5%
Detachment of device or device componentpart of the device came off	393	4.2%
Contamination	312	3.3%
Material integrity problema problem with the device material	311	3.3%
Fluid/blood leak	261	2.8%
Improper flow or infusion	219	2.3%
Nonstandard device	204	2.2%
Breakthe device broke	163	1.7%
Difficult to flush	143	1.5%
Difficult to removethe device was hard to remove	140	1.5%
Air/gas in device	129	1.4%
Positioning failure	125	1.3%
Restricted flow rate	114	1.2%
Activation, positioning or separation problem	113	1.2%
Coagulation in device or device ingredient	86	0.9%

Questions about percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation reports

What is product code QZI?

FDA's classification code for "Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

9,434 reports through August 2026, 5,446 of them in the latest 12 months.

Which brands appear most often?

Farawave (2,585), PulseSelect (2,144), Affera (1,106), FARAWAVE Pulsed Field Ablation Catheter, 31mm (863) and FARAWAVE Pulsed Field Ablation Catheter (550). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.