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

Catalog Number	D139702
Medical Device Problem Codes	Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure and the ngen¿ pump power box "sparked" about thirty minutes after it was powered on.The ngen¿ pump powered down and lost power.The power cable melted where it connected into the power adapter.No other equipment was affected.There was no patient consequence.They disconnected the power supply from the outlet and the ngen¿ pump itself.No other damage was observed.Additional information indicated that no catheter was being used and was not in the procedure.There was an unexpected smell from the equipment like burnt electrical.
Additional Manufacturer Narrative
D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure and the ngen¿ pump power box "sparked" about thirty minutes after it was powered on.The ngen¿ pump powered down and lost power.The power cable melted where it connected into the power adapter.Hardware investigation details: technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for evaluation.Service no longer needed for the customer unit.No further analysis on the system was performed.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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).

• 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: 24646945
• Report Number: 2029046-2026-00928
• Device Sequence Number: 9786320
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NGEN RF GENERATOR, US.
• Patient Sex: Unknown