Devices › Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Device brand name · Similar device ni75tcjh pma p030031
NaviStar ThermoCool: medical device reports filed with FDA
673 reports name it, 2001–2026. Manufacturer given most often on reports: Biosense Webster Irwindale. Product code OAD.
- 673
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 20
- reports, 12 months to August 2026
- 10 in the 12 months before
- 21%
- classified as malfunction
- 48.6% across the product code
- 7%
- classified as death, as reported
- 47 reports · not verified by FDA
673 medical device reports received by FDA name the brand "NaviStar ThermoCool" (similar device ni75tcjh pma p030031); the manufacturer given most often on reports is Biosense Webster Irwindale; received from October 2001 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
20 reports arrived in the 12 months to August 2026, up 100% from 10 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 (71.3%), malfunction (21%) and death (7%); across all catheter, percutaneous, cardiac ablation, for treatment of atrial flutter reports (product code OAD) death is recorded in 3.7% and malfunction in 48.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (20.5%), device operates differently than expected (4.2%) and device displays incorrect message (3%). The patient problems coded most often are cardiac tamponade, hematoma and pericardial effusion. 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 5,961 reports carrying product code OAD. 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 |
|---|---|---|---|
| Insufficient device problem information | 138 | 20.5% | 8.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 28 | 4.2% | 3.1% |
| Device displays incorrect message | 20 | 3% | 3.5% |
| Failure to read input signal | 15 | 2.2% | 0.3% |
| Patient device interaction problem | 11 | 1.6% | 4% |
| Obstruction of flow | 9 | 1.3% | 1% |
| Breakthe device broke | 8 | 1.2% | 2.7% |
| Crackthe device cracked | 7 | 1% | 0.5% |
| Difficult to position | 7 | 1% | 0.3% |
| Positioning problem | 7 | 1% | 1.4% |
| No display/image | 6 | 0.9% | 0.4% |
| Sensor problems | 6 | 0.9% | 0.1% |
| Bent | 5 | 0.7% | 1% |
| Out-of-box failure | 5 | 0.7% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 0.6% | 1.5% |
| Device inoperablethe device could not be used | 4 | 0.6% | 0.1% |
| Insufficient cooling | 4 | 0.6% | 0.4% |
| Signal artifact/noise | 4 | 0.6% | 1.3% |
| Electromagnetic interference | 3 | 0.4% | 0.4% |
| Extrusion | 3 | 0.4% | 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 |
|---|---|---|
| Cardiac tamponade | 134 | 19.9% |
| Hematomaa collection of blood under the skin or in tissue | 53 | 7.9% |
| Pericardial effusionfluid around the heart | 52 | 7.7% |
| Deaththe patient died; cause not stated by this term | 50 | 7.4% |
| Transient ischemic attack | 43 | 6.4% |
| Stroke/cva | 41 | 6.1% |
| Hemorrhage/blood loss/bleeding | 37 | 5.5% |
| Pseudoaneurysm | 26 | 3.9% |
| Fistula | 24 | 3.6% |
| Cardiac perforation | 21 | 3.1% |
| Complete heart block | 17 | 2.5% |
| Heart failure | 17 | 2.5% |
| Nerve damage | 15 | 2.2% |
| Pneumothoraxa collapsed lung | 13 | 1.9% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 13 | 1.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | NaviStar ThermoCool | Product code OAD | All MAUDE reports |
|---|---|---|---|
| Reports | 673 | 5,961 | 26,136,888 |
| Share of that pool | — | 11.3% | 0% |
| Classified as death, per 1,000 reports | 70 | 37 | 9 |
| Classified as injury | 71.3% | 47.2% | 36.2% |
| Classified as malfunction | 21% | 48.6% | 62.3% |
| Filed by the manufacturer | 87.5% | 95.8% | 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 OAD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| IntellaNav MiFi? Open-Irrigated | 466 | 6 | 1.1% |
| IntellaNav MiFi Open-Irrigated Ablation Catheter | 448 | 13 | 1.1% |
| Ez Steer Thermocool Nav Bi-Directional Catheter | 302 | 0 | 6.3% |
| Navi-Star Thermo-Cool Electrophysiology Catheter | 259 | 2 | 1.9% |
| Flexability Ablation Catheter Sensor Enabled | 210 | 9 | 9% |
| Intellatip Mifi Xp Temperature Ablation Catheter | 166 | 0 | 0% |
| Therapy Ablation Catheter | 182 | 7 | 0.5% |
| Navistar Rmt Thermocool Electrophysiology Catheter | 170 | 0 | 7.1% |
| Ampere RF Ablation Generator | 177 | 14 | 1.1% |
| Unk Navistar Thermocool | 220 | 0 | 4.5% |
| Unk Smart Touch Bidirectional | 213 | 0 | 1.4% |
| QDOT Micro | 1,169 | 390 | 3% |
| Thermocool Smarttouch Uni-Directional Navigation Catheter | 663 | 0 | 4.1% |
| Thermocool Smarttouch Bi-Directional Navigation Catheter | 1,224 | 0 | 5% |
| Qdot Micro Catheter | 538 | 37 | 3.5% |
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 NaviStar ThermoCool reports
How many FDA reports name NaviStar ThermoCool?
673 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 20 in the latest 12 months.
What kinds of events are reported?
injury (71.3%), malfunction (21%) and death (7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (20.5%), device operates differently than expected (4.2%), device displays incorrect message (3%), failure to read input signal (2.2%) and patient device interaction problem (1.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (87.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that NaviStar ThermoCool 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.