Devices › Catheter, intracardiac mapping, high-density array
Device brand name · Catheter intracardiac mapping high-density array
Pentaray Nav: medical device reports filed with FDA
399 reports name it, 2017–2026. Manufacturer given most often on reports: Biosense Webster. Product code MTD.
- 399
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 201
- reports, 12 months to August 2026
- 147 in the 12 months before
- 92.2%
- classified as malfunction
- 69% across the product code
- 0.8%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 399 reports that name the brand "Pentaray Nav" (catheter intracardiac mapping high-density array), received between June 2017 and August 2026; the manufacturer given most often on reports is Biosense Webster. Spellings of one product vary from report to report.
201 reports arrived in the 12 months to August 2026, up 37% from 147 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 (92.2%), injury (7%) and death (0.8%); 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 obstruction of flow (62.9%), patient device interaction problem (6.5%) and detachment of device or device component (3.3%). The patient problems coded most often are cardiac tamponade, foreign body in patient and air embolism. 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 |
|---|---|---|---|
| Obstruction of flow | 251 | 62.9% | 24.6% |
| Patient device interaction problem | 26 | 6.5% | 18.7% |
| Detachment of device or device componentpart of the device came off | 13 | 3.3% | 6.3% |
| Material twisted/bent | 12 | 3% | 3.9% |
| Signal artifact/noise | 11 | 2.8% | 4.3% |
| Entrapment of device | 10 | 2.5% | 7% |
| Device-device incompatibility | 9 | 2.3% | 3.1% |
| Material separation | 9 | 2.3% | 2.2% |
| Display or visual feedback problem | 7 | 1.8% | 1.7% |
| Improper or incorrect procedure or method | 7 | 1.8% | 1.5% |
| Positioning problem | 7 | 1.8% | 1% |
| Manufacturing, packaging or shipping problem | 6 | 1.5% | 1.1% |
| Communication or transmission problemthe device could not communicate or transmit | 5 | 1.3% | 1.5% |
| Contamination /decontamination problem | 5 | 1.3% | 4.6% |
| Material protrusion/extrusion | 4 | 1% | 2.3% |
| Breakthe device broke | 3 | 0.8% | 2.6% |
| Coagulation in device or device ingredient | 3 | 0.8% | 3.5% |
| Device displays incorrect message | 3 | 0.8% | 1.2% |
| Device markings/labelling problema problem with the device markings or label | 3 | 0.8% | 0.2% |
| Failure to sense | 3 | 0.8% | 0.6% |
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 | 9 | 2.3% |
| Foreign body in patientpart of a device left in the patient | 9 | 2.3% |
| Air embolism | 3 | 0.8% |
| Cardiac arrestthe heart stopped | 2 | 0.5% |
| Ischemic heart disease | 2 | 0.5% |
| Thrombosis/thrombus | 2 | 0.5% |
| Cardiac perforation | 1 | 0.3% |
| Ischemia stroke | 1 | 0.3% |
| Mitral valve insufficiency/ regurgitation | 1 | 0.3% |
| Myocardial infarctionheart attack | 1 | 0.3% |
| Perforation of vessels | 1 | 0.3% |
| Respiratory failurethe lungs could not supply enough oxygen | 1 | 0.3% |
| Rupturethe device burst | 1 | 0.3% |
| Stroke/cva | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pentaray Nav | Product code MTD | All MAUDE reports |
|---|---|---|---|
| Reports | 399 | 1,890 | 26,136,888 |
| Share of that pool | — | 21.1% | 0% |
| Classified as death, per 1,000 reports | 8 | 16 | 9 |
| Classified as injury | 7% | 28.6% | 36.2% |
| Classified as malfunction | 92.2% | 69% | 62.3% |
| Filed by the manufacturer | 91.2% | 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 |
|---|---|---|---|
| Pentaray Nav High-Density Mapping Eco Catheter | 533 | 9 | 1.3% |
| OCTARAY Mapping Catheter | 399 | 99 | 1.5% |
| 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 reports
How many FDA reports name Pentaray Nav?
399 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 201 in the latest 12 months.
What kinds of events are reported?
malfunction (92.2%), injury (7%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
obstruction of flow (62.9%), patient device interaction problem (6.5%), detachment of device or device component (3.3%), material twisted/bent (3%) and signal artifact/noise (2.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (91.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pentaray Nav 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.