Devices › Device types
FDA product code OAD · class 3 · Unknown
Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter: medical device reports filed with FDA
5,961 reports carry this product code, 2006–2026; 30 brands with a page.
- 5,961
- reports with this product code
- 0% of all MAUDE reports
- 252
- reports, 12 months to August 2026
- 209 in the 12 months before
- 48.6%
- classified as malfunction
- 62.3% across all reports
- 3.7%
- classified as death, as reported
- 0.9% across all reports
Product code OAD is FDA's classification for "Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter" (unknown panel), a class 3 device. 5,961 medical device reports carry this product code, 0% of the MAUDE database, from July 2006 to August 2026.
252 reports arrived in the 12 months to August 2026, up 21% from 209 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 (48.6%), injury (47.2%) and death (3.7%). 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 |
|---|---|---|
| Biosense Webster | 931 | 15.6% |
| St Jude Medical | 720 | 12.1% |
| Biosense Webster Juarez | 679 | 11.4% |
| Biosense Webster Irwindale | 502 | 8.4% |
| Boston Scientific - Costa Rica Heredia | 294 | 4.9% |
| St Jude Medical Costa Rica Ltda | 50 | 0.8% |
| Boston Scientific - Fremont Ce | 27 | 0.5% |
| Boston Scientific - Fremont Sud | 1 | 0% |
| Medtronic Vascular | 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 |
|---|---|---|
| Insufficient device problem information | 484 | 8.1% |
| Fluid/blood leak | 337 | 5.7% |
| Material integrity problema problem with the device material | 276 | 4.6% |
| Temperature problem | 260 | 4.4% |
| Leak/splashthe device leaked | 237 | 4% |
| Patient device interaction problem | 237 | 4% |
| Detachment of device component | 223 | 3.7% |
| Device displays incorrect message | 211 | 3.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 185 | 3.1% |
| Breakthe device broke | 161 | 2.7% |
| Charred | 87 | 1.5% |
| Communication or transmission problemthe device could not communicate or transmit | 87 | 1.5% |
| Positioning problem | 82 | 1.4% |
| Signal artifact/noise | 78 | 1.3% |
| Improper flow or infusion | 73 | 1.2% |
| Defective devicethe device was defective | 62 | 1% |
| High impedance | 62 | 1% |
| Obstruction of flow | 62 | 1% |
| Bent | 61 | 1% |
| Kinkedthe tube or line kinked | 60 | 1% |
Questions about catheter, percutaneous, cardiac ablation, for treatment of atrial flutter reports
What is product code OAD?
FDA's classification code for "Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
5,961 reports through August 2026, 252 of them in the latest 12 months.
Which brands appear most often?
IntellaNav MiFi? Open-Irrigated (466), IntellaNav MiFi Open-Irrigated Ablation Catheter (447), NaviStar ThermoCool (315), Ez Steer Thermocool Nav Bi-Directional Catheter (296) and Navi-Star Thermo-Cool Electrophysiology Catheter (258). 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.