NGEN PUMP
Report
- Report Number
- 2029046-2025-04093
- Event Type
- Malfunction
- Date Received
- December 10, 2025
- Date of Event
- June 4, 2025
- Report Date
- March 10, 2026
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835017465
- PMA / PMN Number
- P990071
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E1. INITIAL REPORTER PHONE: (B)(6). D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO NGEN PUMP APPROVED UNDER P990071. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 PREMATURE VENTRICULAR CONTRACTION CARDIAC ABLATION PROCEDURE WITH A NGEN PUMP. THE SCREEN FOR THE NGEN PUMP BLACKED OUT AND DID NOT WORK. ERROR 4 WAS NOTED ON THE NGEN PUMP. CHANGED THE CABLE ORGANIZATION AND ATTEMPTED RESTART, BUT DID NOT RESTART. NGEN PUMP COULD NOT BE USED. THE NGEN PUMP MONITOR WAS NO LONGER DISPLAYED WHEN THE POWER WAS TURNED ON. DURING THE VERIFICATION, CONFIRMED AN ISSUE WHERE THE NGEN PUMP SUDDENLY REBOOTED WHILE OPERATING, AND A CPU WATCHDOG ERROR OCCURRED AT STARTUP. ADDITIONALLY, OBSERVED THE OCCURRENCE OF AN INTERNAL ERROR INDICATOR LIGHTING UP DURING USE, WHICH RESULTED IN THE SYSTEM BECOMING UNRESPONSIVE TO OPERATIONS. REPORTED THAT THE NGEN PUMP WAS THE CAUSE OF THE IRRIGATION ISSUE. THE SYSTEM EVALUATION WAS COMPLETED ON 12-FEB-2026. THE DEVICE WAS RECEIVED AT A REPAIR SITE FOR EVALUATION. WORK ORDER SERVICE REPORT WAS SENT TO JOHNSON & JOHNSON MEDTECH. AFTER SEVERAL TESTS, THE FAILURE WAS NO LONGER REPRODUCED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF THE QUALITY PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
DURING ADDITIONAL REVIEW, CORRECTED CODE UNDER "H6. MEDICAL DEVICE PROBLEM CODE" FROM OBSTRUCTION OF FLOW (A1409) TO UNEXPECTED SHUTDOWN (A0719). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
H4. DEVICE MANUFACTURE DATE AND D4. PRIMARY UDI NUMBER HAVE BEEN ADDED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
INITIALLY, THE IRRIGATION ISSUE WAS ASSESSED AS MDR REPORTABLE AND REPORTED UNDER THE QDOT MICRO CATHETER (MANUFACTURER REPORT NUMBER: 2029046-2025-02122) AND THE SMARTABLATE IRRIGATION TUBING SET (MANUFACTURER REPORT NUMBER: 2029046-2025-02123); HOWEVER, BWI BECAME AWARE ON 18-NOV-2025 THAT THE TUBING SET WAS NOT REPLACED AND ALSO REPORTED THAT THE NGEN PUMP WAS THE CAUSE OF THE IRRIGATION ISSUE AND HAVE THEREFORE, ASSESSED THE NGEN PUMP AS ALSO REPORTABLE AND HAVE DOWNGRADED TO NOT REPORTABLE THE SMARTABLATE IRRIGATION TUBING SET. THE REPORTABLE AWARENESS DATE FOR THE NGEN PUMP IS 18-NOV-2025. IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND A SMARTABLATE IRRIGATION TUBING SET. JUST BEFORE ABLATION, THE QDOT MICRO CATHETER AND THE SMARTABLATE IRRIGATION TUBING SET COULD NOT PERFORM FLUSHING. RECONNECTED AND PERFORMED FLUSHING, BUT COULD NOT. THE CATHETER WAS REPLACED WITH AN ABLATION CATHETER FROM ANOTHER COMPANY. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT PATIENT CONSEQUENCE. THE IRRIGATION ISSUE WAS NOTED AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THE IRRIGATION ISSUE WAS NOTED DURING USE OF THE TUBING. THE TUBING WAS USED ON THE PATIENT. THE IRRIGATION ISSUE WAS NOTED BEFORE ABLATION STARTED. NO FOREIGN MATERIAL OR PHYSICAL DAMAGE. THE SCREEN FOR THE NGEN PUMP BLACKED OUT AND DID NOT WORK. ERROR 4 WAS NOTED ON THE NGEN PUMP. CHANGED THE CABLE ORGANIZATION AND ATTEMPTED RESTART, BUT DID NOT RESTART. NGEN PUMP COULD NOT BE USED. THE NGEN PUMP MONITOR WAS NO LONGER DISPLAYED WHEN THE POWER WAS TURNED ON. DURING THE VERIFICATION, CONFIRMED AN ISSUE WHERE THE NGEN PUMP SUDDENLY REBOOTED WHILE OPERATING, AND A CPU WATCHDOG ERROR OCCURRED AT STARTUP. ADDITIONALLY, OBSERVED THE OCCURRENCE OF AN INTERNAL ERROR INDICATOR LIGHTING UP DURING USE, WHICH RESULTED IN THE SYSTEM BECOMING UNRESPONSIVE TO OPERATIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 18-NOV-2025. THE TUBING WAS NOT REPLACED. THE NGEN PUMP WAS THE CAUSE OF THE IRRIGATION ISSUE. THE NGEN PUMP SYSTEM WAS SWITCHED TO THE NON-BW SYSTEM (NON- IRRIGATING SYSTEM). THEREFORE, THE PUMP WAS NOT REPLACED AND WAS NOT USED. THE NGEN PUMP BLACKED OUT/DID NOT WORK ISSUE AND THE ERROR 4 ISSUE WERE ASSESSED AS NON MDR REPORTABLE ISSUES. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT THEY COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WERE REMOTE. SINCE IT WAS REPORTED ON 18-NOV-2025 THAT THE NGEN PUMP WAS THE CAUSE OF THE IRRIGATION ISSUE, ASSESSED THE NGEN PUMP ALSO AS REPORTABLE. THE REPORTABLE AWARENESS DATE FOR THE NGEN PUMP IS 18-NOV-2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382895 | NGEN PUMP | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 10846835017465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | JPN CARTO 3 SYSTEM.| QDOT MICRO, BI, TC, D-F.| SMARTABLATE IRR TUBE SET.| UNK CABLE. |