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FDA product code OAE · class 3 · Unknown
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation: medical device reports filed with FDA
11,466 reports carry this product code, 2009–2026; 30 brands with a page.
- 11,466
- reports with this product code
- 0% of all MAUDE reports
- 1,088
- reports, 12 months to August 2026
- 1,719 in the 12 months before
- 49%
- classified as malfunction
- 62.3% across all reports
- 3%
- classified as death, as reported
- 0.9% across all reports
Product code OAE is FDA's classification for "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation" (unknown panel), a class 3 device. 11,466 medical device reports carry this product code, 0% of the MAUDE database, from February 2009 to August 2026.
1,088 reports arrived in the 12 months to August 2026, down 37% from 1,719 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 (49%), injury (47.9%) and death (3%). 30 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
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 |
|---|---|---|
| Medtronic Cryocath | 3,515 | 30.7% |
| St Jude Medical | 1,996 | 17.4% |
| Biosense Webster | 1,851 | 16.1% |
| Mpri | 578 | 5% |
| St Jude Medical Costa Rica Ltda | 385 | 3.4% |
| Medtronic Puerto Rico Villalba | 213 | 1.9% |
| Biosense Webster Juarez | 24 | 0.2% |
| Boston Scientific - Costa Rica Heredia | 17 | 0.1% |
| Biosense Webster Irwindale | 1 | 0% |
| Medtronic Mexico | 1 | 0% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Material twisted/bent | 969 | 8.5% |
| Patient device interaction problem | 956 | 8.3% |
| Material integrity problema problem with the device material | 714 | 6.2% |
| Device contamination with body fluid | 664 | 5.8% |
| Optical problem | 490 | 4.3% |
| Fluid/blood leak | 376 | 3.3% |
| Protective measures problem | 355 | 3.1% |
| Communication or transmission problemthe device could not communicate or transmit | 335 | 2.9% |
| Incorrect, inadequate or imprecise result or readings | 295 | 2.6% |
| Insufficient device problem information | 295 | 2.6% |
| Fracturea broken bone | 244 | 2.1% |
| Coagulation in device or device ingredient | 203 | 1.8% |
| Material deformation | 188 | 1.6% |
| Temperature problem | 148 | 1.3% |
| Insufficient cooling | 147 | 1.3% |
| Contamination /decontamination problem | 141 | 1.2% |
| Gas/air leak | 138 | 1.2% |
| Device displays incorrect message | 128 | 1.1% |
| Electrical shorting | 121 | 1.1% |
| Obstruction of flow | 116 | 1% |
Questions about catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation reports
What is product code OAE?
FDA's classification code for "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
11,466 reports through August 2026, 1,088 of them in the latest 12 months.
Which brands appear most often?
Arctic Front Advance Cardiac Cryoablation Catheter (2,356), Arctic Front Advance Pro Cardiac Cryoablation Catheter (1,727), TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F (1,085), QDOT Micro (1,081) and Tacticath Quartz Contact Force Ablation Catheter 75mm (628). 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.