Devices › Catheter, intracardiac mapping, high-density array
Device brand name · Catheter intracardiac mapping high-density array
Pentaray Nav High-Density Mapping Eco Catheter: medical device reports filed with FDA
533 reports name it, 2018–2025. Manufacturer given most often on reports: Biosense Webster. Product code MTD.
- 533
- device reports naming the brand
- 0% of all MAUDE reports · about 63 a year
- 9
- reports, 12 months to August 2026
- 38 in the 12 months before
- 68.1%
- classified as malfunction
- 69% across the product code
- 1.3%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 533 reports that name the brand "Pentaray Nav High-Density Mapping Eco Catheter" (catheter intracardiac mapping high-density array), received between February 2018 and November 2025; the manufacturer given most often on reports is Biosense Webster. Spellings of one product vary from report to report.
9 reports arrived in the 12 months to August 2026, down 76% from 38 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 (68.1%), injury (30.6%) and death (1.3%); across all catheter, intracardiac mapping, high-density array reports (product code MTD) death is recorded in 1.6% and malfunction in 69%. 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 (21.8%), obstruction of flow (19.9%) and entrapment of device (11.1%). The patient problems coded most often are cardiac tamponade, foreign body in patient and cardiac arrest. 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 1,890 reports carrying product code MTD. 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 | 116 | 21.8% | 18.7% |
| Obstruction of flow | 106 | 19.9% | 24.6% |
| Entrapment of device | 59 | 11.1% | 7% |
| Detachment of device or device componentpart of the device came off | 57 | 10.7% | 6.3% |
| Signal artifact/noise | 36 | 6.8% | 4.3% |
| Contamination /decontamination problem | 33 | 6.2% | 4.6% |
| Coagulation in device or device ingredient | 30 | 5.6% | 3.5% |
| Sharp edges | 28 | 5.3% | 1.6% |
| Device contamination with body fluid | 27 | 5.1% | 4.6% |
| Material protrusion/extrusion | 27 | 5.1% | 2.3% |
| Material twisted/bent | 25 | 4.7% | 3.9% |
| Device-device incompatibility | 23 | 4.3% | 3.1% |
| Breakthe device broke | 19 | 3.6% | 2.6% |
| Complete blockage | 15 | 2.8% | 1% |
| Display or visual feedback problem | 15 | 2.8% | 1.7% |
| Material separation | 15 | 2.8% | 2.2% |
| Material deformation | 11 | 2.1% | 1.5% |
| Mechanical jam | 9 | 1.7% | 0.8% |
| Positioning problem | 5 | 0.9% | 1% |
| Improper or incorrect procedure or method | 4 | 0.8% | 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 | 62 | 11.6% |
| Foreign body in patientpart of a device left in the patient | 40 | 7.5% |
| Cardiac arrestthe heart stopped | 13 | 2.4% |
| Air embolism | 7 | 1.3% |
| Ischemic heart disease | 7 | 1.3% |
| Thrombosis/thrombus | 7 | 1.3% |
| Cardiac perforation | 6 | 1.1% |
| Stroke/cva | 6 | 1.1% |
| Device embedded in tissue or plaque | 4 | 0.8% |
| Heart block | 4 | 0.8% |
| Rupturethe device burst | 4 | 0.8% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 4 | 0.8% |
| Low blood pressure/ hypotension | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Deaththe patient died; cause not stated by this term | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pentaray Nav High-Density Mapping Eco Catheter | Product code MTD | All MAUDE reports |
|---|---|---|---|
| Reports | 533 | 1,890 | 26,136,888 |
| Share of that pool | — | 28.2% | 0% |
| Classified as death, per 1,000 reports | 13 | 16 | 9 |
| Classified as injury | 30.6% | 28.6% | 36.2% |
| Classified as malfunction | 68.1% | 69% | 62.3% |
| Filed by the manufacturer | 100% | 94.9% | 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 MTD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| OCTARAY Mapping Catheter | 399 | 99 | 1.5% |
| Pentaray Nav | 399 | 201 | 0.8% |
| Advisor HD Grid Mapping Catheter, Sensor Enabled | 480 | 32 | 3.3% |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath Medium | 1,381 | 0 | 0.1% |
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 Pentaray Nav High-Density Mapping Eco Catheter reports
How many FDA reports name Pentaray Nav High-Density Mapping Eco Catheter?
533 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
malfunction (68.1%), injury (30.6%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (21.8%), obstruction of flow (19.9%), entrapment of device (11.1%), detachment of device or device component (10.7%) and signal artifact/noise (6.8%). 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 Pentaray Nav High-Density Mapping Eco 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.