Devices › Cardiac ablation percutaneous catheter
Device brand name · Cardiac ablation percutaneous catheter
Thermocool Smart Touch Bi-Directional Navigation Catheter: medical device reports filed with FDA
512 reports name it, 2014–2024. Manufacturer given most often on reports: Biosense Webster. Product code LPB.
- 512
- device reports naming the brand
- 0% of all MAUDE reports · about 41 a year
- 0
- reports, 12 months to August 2026
- 6 in the 12 months before
- 26.6%
- classified as malfunction
- 37% across the product code
- 8%
- classified as death, as reported
- 41 reports · not verified by FDA
512 medical device reports received by FDA name the brand "Thermocool Smart Touch Bi-Directional Navigation Catheter" (cardiac ablation percutaneous catheter); the manufacturer given most often on reports is Biosense Webster; received from February 2014 to December 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 6 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 (65.4%), malfunction (26.6%) and death (8%); across all cardiac ablation percutaneous catheter reports (product code LPB) death is recorded in 4.4% and malfunction in 37%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are patient device interaction problem (32.2%), material puncture/hole (8.6%) and contamination /decontamination problem (2.7%). The patient problems coded most often are cardiac tamponade, death and heart block. 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 16,527 reports carrying product code LPB. 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 |
|---|---|---|---|
| Patient device interaction problem | 165 | 32.2% | 23.8% |
| Material puncture/hole | 44 | 8.6% | 4.1% |
| Contamination /decontamination problem | 14 | 2.7% | 2.9% |
| High readingsreadings were too high | 12 | 2.3% | 2.1% |
| Coagulation in device or device ingredient | 11 | 2.1% | 1.6% |
| Insufficient cooling | 10 | 2% | 1.2% |
| Electrical shorting | 8 | 1.6% | 0.6% |
| Incorrect, inadequate or imprecise result or readings | 8 | 1.6% | 3.6% |
| Material split, cut or torn | 7 | 1.4% | 0.4% |
| Entrapment of device | 6 | 1.2% | 0.6% |
| Temperature problem | 6 | 1.2% | 1.6% |
| Communication or transmission problemthe device could not communicate or transmit | 5 | 1% | 0.9% |
| Device contamination with body fluid | 5 | 1% | 1.4% |
| Detachment of device or device componentpart of the device came off | 4 | 0.8% | 0.3% |
| Device contamination with chemical or other material | 4 | 0.8% | 1.3% |
| High impedance | 4 | 0.8% | 0.9% |
| Hole in material | 4 | 0.8% | 0.7% |
| Positioning problem | 4 | 0.8% | 1.3% |
| Signal artifact/noise | 4 | 0.8% | 1.9% |
| Breakthe device broke | 3 | 0.6% | 1.5% |
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 | 233 | 45.5% |
| Deaththe patient died; cause not stated by this term | 24 | 4.7% |
| Heart block | 24 | 4.7% |
| Stroke/cva | 24 | 4.7% |
| Cardiac arrestthe heart stopped | 21 | 4.1% |
| Pericarditisinflammation of the sac around the heart | 15 | 2.9% |
| Pericardial effusionfluid around the heart | 13 | 2.5% |
| Fistula | 11 | 2.1% |
| Cardiac perforation | 10 | 2% |
| Hemorrhage/blood loss/bleeding | 9 | 1.8% |
| Ischemic heart disease | 9 | 1.8% |
| Myocardial infarctionheart attack | 8 | 1.6% |
| Arrhythmia | 6 | 1.2% |
| Not applicable | 6 | 1.2% |
| Vascular dissection | 6 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Thermocool Smart Touch Bi-Directional Navigation Catheter | Product code LPB | All MAUDE reports |
|---|---|---|---|
| Reports | 512 | 16,527 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 80 | 44 | 9 |
| Classified as injury | 65.4% | 58.2% | 36.2% |
| Classified as malfunction | 26.6% | 37% | 62.3% |
| Filed by the manufacturer | 100% | 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 LPB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Thermocool Smart Touch Sf Bi-Directional Navigation Catheter | 4,538 | 22 | 4.5% |
| ThermoCool SmartTouch SF | 1,722 | 657 | 3.8% |
| Thermocool Smarttouch Bi-Directional Navigation Catheter | 1,224 | 0 | 5% |
| Thermocool Smart Touch Sf Uni-Directional Navigation Catheter | 881 | 14 | 3.7% |
| Thermocool Smart Touch Electrophysiology Catheter | 715 | 5 | 2.8% |
| Thermocool Smarttouch Uni-Directional Navigation Catheter | 663 | 0 | 4.1% |
| Thermocool Sf Nav Bi-Directional Catheter | 607 | 0 | 6.3% |
| Thermocool Smarttouch Sf Bi-Directional Nav Catheter | 354 | 0 | 3.4% |
| NaviStar ThermoCool | 673 | 20 | 7% |
| ThermoCool SmartTouch | 313 | 100 | 2.6% |
| CryoConsole | 318 | 15 | 1.6% |
| Thermocool Sf Nav Uni-Directional Catheter | 292 | 0 | 4.1% |
| Ez Steer Nav Bi-Directional Electrophysiology Catheter | 184 | 1 | 3.8% |
| Unk Smart Touch Bidirectional | 213 | 0 | 1.4% |
| Unk Navistar Thermocool | 220 | 0 | 4.5% |
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 Thermocool Smart Touch Bi-Directional Navigation Catheter reports
How many FDA reports name Thermocool Smart Touch Bi-Directional Navigation Catheter?
512 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (65.4%), malfunction (26.6%) and death (8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (32.2%), material puncture/hole (8.6%), contamination /decontamination problem (2.7%), high readings (2.3%) and coagulation in device or device ingredient (2.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Thermocool Smart Touch Bi-Directional Navigation Catheter 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.