Devices › Catheter, electrode recording, or probe, electrode recording
Device brand name · Catheter electrode recording or probe electrode recording
Decanav Electrophysiology Catheter: medical device reports filed with FDA
153 reports name it, 2015–2025. Manufacturer given most often on reports: Biosense Webster. Product code DRF.
- 153
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 4
- reports, 12 months to August 2026
- 11 in the 12 months before
- 32.7%
- classified as malfunction
- 48.8% across the product code
- 3.3%
- classified as death, as reported
- 5 reports · not verified by FDA
153 medical device reports received by FDA name the brand "Decanav Electrophysiology Catheter" (catheter electrode recording or probe electrode recording); the manufacturer given most often on reports is Biosense Webster; received from February 2015 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
4 reports arrived in the 12 months to August 2026, down 64% from 11 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 (64.1%), malfunction (32.7%) and death (3.3%); across all catheter, electrode recording, or probe, electrode recording reports (product code DRF) death is recorded in 3.5% and malfunction in 48.8%. 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 (49%), signal artifact/noise (5.2%) and manufacturing, packaging or shipping problem (3.3%). The patient problems coded most often are cardiac tamponade, cardiac perforation 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 8,781 reports carrying product code DRF. 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 | 75 | 49% | 4.7% |
| Signal artifact/noise | 8 | 5.2% | 1.7% |
| Manufacturing, packaging or shipping problem | 5 | 3.3% | 0.3% |
| Material protrusion/extrusion | 5 | 3.3% | 0.4% |
| Mechanical jam | 5 | 3.3% | 0.6% |
| Tear, rip or hole in device packaging | 5 | 3.3% | 0.3% |
| Contamination /decontamination problem | 4 | 2.6% | 0.7% |
| Electrical shorting | 4 | 2.6% | 0.1% |
| Breakthe device broke | 3 | 2% | 3% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 2% | 1.2% |
| Delivered as unsterile product | 3 | 2% | 0.3% |
| Display or visual feedback problem | 2 | 1.3% | 0.6% |
| Failure to sense | 2 | 1.3% | 0.8% |
| Material twisted/bent | 2 | 1.3% | 9.3% |
| Detachment of device or device componentpart of the device came off | 1 | 0.7% | 1.1% |
| Device-device incompatibility | 1 | 0.7% | 0.3% |
| Material deformation | 1 | 0.7% | 4.4% |
| Material separation | 1 | 0.7% | 1.8% |
| Mechanical problema mechanical problem | 1 | 0.7% | 1% |
| Packaging problem | 1 | 0.7% | 0.1% |
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 | 54 | 35.3% |
| Cardiac perforation | 11 | 7.2% |
| Cardiac arrestthe heart stopped | 9 | 5.9% |
| Vascular dissection | 4 | 2.6% |
| Heart block | 3 | 2% |
| Ischemic heart disease | 3 | 2% |
| Low blood pressure/ hypotension | 3 | 2% |
| Perforation of vessels | 3 | 2% |
| Thrombosis/thrombus | 3 | 2% |
| Pneumothoraxa collapsed lung | 2 | 1.3% |
| Air embolism | 1 | 0.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.7% |
| Arrhythmia | 1 | 0.7% |
| Bradycardiaslow heart rate | 1 | 0.7% |
| Failure of implant | 1 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Decanav Electrophysiology Catheter | Product code DRF | All MAUDE reports |
|---|---|---|---|
| Reports | 153 | 8,781 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 33 | 35 | 9 |
| Classified as injury | 64.1% | 47.1% | 36.2% |
| Classified as malfunction | 32.7% | 48.8% | 62.3% |
| Filed by the manufacturer | 99.3% | 94.8% | 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 DRF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Achieve Mapping Catheter - 20 mm | 1,171 | 82 | 3.1% |
| Achieve Mapping Catheter | 645 | 0 | 4.7% |
| Advisor HD Grid Mapping Catheter, Sensor Enabled | 480 | 32 | 3.3% |
| Intellamap Orion High Resolution Mapping Catheter | 386 | 0 | 4.1% |
| Achieve Advance Mapping Catheter | 361 | 34 | 4.4% |
| IntellaMap Orion | 261 | 52 | 0.8% |
| Lasso 2515 Nav Eco Variable Catheter | 231 | 0 | 0.4% |
| Inquiry Steerable Diagnostic Catheter | 233 | 8 | 3.9% |
| Stockert 70 Rf Generator | 212 | 0 | 4.2% |
| Lasso 2515 Nav Variable Catheter | 188 | 0 | 0.5% |
| Navistar Electrophysiology Catheter | 184 | 0 | 6% |
| NaviStar ThermoCool | 673 | 20 | 7% |
| Polarsheath | 418 | 12 | 1.2% |
| Viking | 181 | 1 | 5% |
| QDOT Micro | 1,169 | 390 | 3% |
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 Decanav Electrophysiology Catheter reports
How many FDA reports name Decanav Electrophysiology Catheter?
153 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.
What kinds of events are reported?
injury (64.1%), malfunction (32.7%) and death (3.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (49%), signal artifact/noise (5.2%), manufacturing, packaging or shipping problem (3.3%), material protrusion/extrusion (3.3%) and mechanical jam (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Decanav Electrophysiology 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.