NGEN RF GENERATOR
Report
- Report Number
- 2029046-2025-02637
- Event Type
- Malfunction
- Date Received
- August 12, 2025
- Date of Event
- July 16, 2025
- Report Date
- February 17, 2026
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835016109
- PMA / PMN Number
- P030031/S053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON 26-JAN-2026, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NGEN RF GENERATOR AND THE MEDICAL TEAM REALIZED THAT THERE WAS 0 ML/MIN FLOW ON THE NGEN MONITOR AND AFTER CHECKING THE PUMP NOTICED A BUBBLE ERROR BUT NO AUDIBLE ALARM HAD GONE OFF AT ALL. DEVICE INVESTIGATION DETAILS: NO WORK ORDER OR ANY OTHER EVIDENCE OF ANALYSIS FOR THIS DEVICE WAS SENT TO JOHNSON & JOHNSON MEDTECH FOR EVALUATION. AFTER CHECKING THE MONITOR SETTINGS, THEY NOTICED THE HOSPITAL HAD TURNED OFF THE ALARM TONE FOR THE GENERATOR AND THAT WAS WHY THEY DID NOT GET THE ALERT. THE SERVICE WAS DECLINED AND NO FURTHER INFORMATION WAS RECEIVED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 23050094FG, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
NOTE: PER FDA REQUEST, MDR SUBMISSIONS FOR THE NGEN RF GENERATOR ARE TO BE REPORTED WITH PMA DETAILS OF THE CATHETER USED ALONG WITH THE NGEN RF GENERATOR. HOWEVER, THE CATHETER USED IN THIS CASE IS CURRENTLY UNKNOWN, THEREFORE NO PMA DETAILS ARE AVAILABLE. FOLLOW-UP WAS PERFORMED AND NO ADDITIONAL INFORMATION WAS PROVIDED. THEREFORE, THIS FILE IS PROCESSED WITH THE ABLATION CATHETER INFORMATION OF THE SMART TOUCH SF. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NGEN RF GENERATOR AND THE MEDICAL TEAM REALIZED THAT THERE WAS 0 ML/MIN FLOW ON THE NGEN MONITOR AND AFTER CHECKING THE PUMP NOTICED A BUBBLE ERROR BUT NO AUDIBLE ALARM HAD GONE OFF AT ALL. THE FLUID LEVEL ON THE NGEN MONITOR SHOWED THAT THERE WAS 47ML OF FLUID STILL LEFT IN THE BAG BUT AFTER CHECKING THE BAG WE NOTICED THAT THERE WAS NO FLUID IN THE BAG AT ALL. THE TEAM DID NOT KNOW HOW MANY LESIONS THEY HAD CREATED WITH NO FLUID, IF ANY. THE CATHETER WAS INSPECTED AND THERE WAS NO CHAR. THE CASE WAS STILL SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. AFTER THE CASE WAS COMPLETED, THE TEAM RECHECKED THE GENERATOR TO SEE IF THEY COULD REPLICATE THE ISSUE AND WHEN IT HIT THE 100ML WARNING LEVEL, THE SYSTEM ONCE AGAIN DID NOT ALARM AT ALL. IT WAS THEN NOTED THAT THE HOSPITAL HAD TURNED OFF THE ALARM AUDIO TONE FOR THE GENERATOR. HOWEVER, IT IS NOT CONFIRMED WHETHER OR NOT A VISUAL MESSAGE APPEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099847 | NGEN RF GENERATOR | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 10846835016109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | TRUPULSE GENERATOR, WW |