Devices › Cardiac ablation percutaneous catheter
Device brand name · Cardiac ablation percutaneous catheter
Thermocool Smarttouch Uni-Directional Navigation Catheter: medical device reports filed with FDA
663 reports name it, 2014–2017. Manufacturer given most often on reports: Biosense Webster Juarez. Product code LPB.
- 663
- device reports naming the brand
- 0% of all MAUDE reports · about 53 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 34.1%
- classified as malfunction
- 37% across the product code
- 4.1%
- classified as death, as reported
- 27 reports · not verified by FDA
663 medical device reports received by FDA name the brand "Thermocool Smarttouch Uni-Directional Navigation Catheter" (cardiac ablation percutaneous catheter); the manufacturer given most often on reports is Biosense Webster Juarez; received from January 2014 to November 2017. 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, and none 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 (61.8%), malfunction (34.1%) and death (4.1%); 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 insufficient device problem information (21.3%), device operates differently than expected (8.9%) and break (6.8%). The patient problems coded most often are cardiac tamponade, pericardial effusion and low blood pressure/ hypotension. 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
No report naming Thermocool Smarttouch Uni-Directional Navigation Catheter was received in the five years to August 2026; the latest was received in November 2017.
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 |
|---|---|---|---|
| Insufficient device problem information | 141 | 21.3% | 6.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 59 | 8.9% | 2.6% |
| Breakthe device broke | 45 | 6.8% | 1.5% |
| Device displays incorrect message | 43 | 6.5% | 2.3% |
| Device contamination with chemical or other material | 31 | 4.7% | 1.3% |
| Hole in material | 23 | 3.5% | 0.7% |
| Bent | 21 | 3.2% | 0.4% |
| Noise, audible | 21 | 3.2% | 0.8% |
| Charred | 18 | 2.7% | 1% |
| Scratched material | 16 | 2.4% | 0.3% |
| Positioning problem | 15 | 2.3% | 1.3% |
| Signal artifact/noise | 14 | 2.1% | 1.9% |
| Improper or incorrect procedure or method | 13 | 2% | 0.7% |
| Temperature problem | 13 | 2% | 1.6% |
| No display/image | 12 | 1.8% | 0.7% |
| Crackthe device cracked | 11 | 1.7% | 0.7% |
| Communication or transmission problemthe device could not communicate or transmit | 10 | 1.5% | 0.9% |
| Device inoperablethe device could not be used | 9 | 1.4% | 0.3% |
| Material integrity problema problem with the device material | 8 | 1.2% | 0.6% |
| Sticking | 8 | 1.2% | 0.3% |
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 | 215 | 32.4% |
| Pericardial effusionfluid around the heart | 101 | 15.2% |
| Low blood pressure/ hypotension | 87 | 13.1% |
| Deaththe patient died; cause not stated by this term | 30 | 4.5% |
| Fistula | 29 | 4.4% |
| Hematomaa collection of blood under the skin or in tissue | 21 | 3.2% |
| Hemorrhage/blood loss/bleeding | 21 | 3.2% |
| Stroke/cva | 21 | 3.2% |
| Cardiac arrestthe heart stopped | 14 | 2.1% |
| Atrial fibrillationan irregular heart rhythm | 13 | 2% |
| Injurya physical injury | 13 | 2% |
| Cardiac perforation | 11 | 1.7% |
| Chest painchest pain | 9 | 1.4% |
| Perforation | 9 | 1.4% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 9 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Thermocool Smarttouch Uni-Directional Navigation Catheter | Product code LPB | All MAUDE reports |
|---|---|---|---|
| Reports | 663 | 16,527 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 41 | 44 | 9 |
| Classified as injury | 61.8% | 58.2% | 36.2% |
| Classified as malfunction | 34.1% | 37% | 62.3% |
| Filed by the manufacturer | 99.1% | 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 Sf Nav Bi-Directional Catheter | 607 | 0 | 6.3% |
| Thermocool Smart Touch Bi-Directional Navigation Catheter | 512 | 0 | 8% |
| 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 Smarttouch Uni-Directional Navigation Catheter reports
How many FDA reports name Thermocool Smarttouch Uni-Directional Navigation Catheter?
663 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 (61.8%), malfunction (34.1%) and death (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (21.3%), device operates differently than expected (8.9%), break (6.8%), device displays incorrect message (6.5%) and device contamination with chemical or other material (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Thermocool Smarttouch Uni-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.