MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D139702
Medical Device Problem Codes	Communication or Transmission Problem (2896); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation details: the product investigation was completed as no work order or any other evidence of analysis for this device was sent to johnson & johnson medtech for evaluation.The service was declined.No further analysis on the system was performed.A device history record review was performed for the finished device 110623-112 number, and no internal actions related to the complaint were found during the review.As part of the quality process, the devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a left-side atrial flutter ablation procedure with a ngen pump and the device rebooted on its own.The j&j representative on site reported that the message "pump not connected" was being displayed on the ngen¿ monitor.They reseated the cables without resolution.The they manually rebooted the ngen¿ generator and the issue was resolved.The procedure continued.No patient consequences were reported.

• Brand Name: NGEN PUMP
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER, INC.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25032519
• Report Number: 2029046-2026-01403
• Device Sequence Number: 13286136
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472(11)231106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D139702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown