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

Catalog Number	D138402
Medical Device Problem Codes	Device Emits Odor (1425); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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, was not provided, therefore no pma details are available.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 ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) pulse field ablation procedure with a ngen generator and while the patient was on the table, one of the saline pressure bags got a pin hole in it and started spraying on the ngen power supply unit.When the saline sprayed onto the power supply unit, which was powered on, it smelled like smoke and started popping and cracking.The ngen system was not being used at the time but was powered on.The saline didn't get on any other biosense webster inc.Equipment and no other areas were affected.The power supply unit was unplugged from boom.There were no patient consequences reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
On 2-may-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) pulse field ablation procedure with a ngen generator and while the patient was on the table, one of the saline pressure bags got a pin hole in it and started spraying on the ngen power supply unit.When the saline sprayed onto the power supply unit, which was powered on, it smelled like smoke and started popping and cracking.The ngen system was not being used at the time but was powered on.The saline didn't get on any other biosense webster inc.Equipment and no other areas were affected.The power supply unit was unplugged from boom.Device evaluation details: technical services performed a remote evaluation of the device.The work order service report was sent to johnson & johnson medtech for evaluation.No visible sign of damage/water damage.The power supply and the cable were replaced to solve the problem.After this, the system was fully operational.A device history record evaluation was performed for the finished device number 23300157fg, and no internal actions related to the reported condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of johnson & johnson medtech's 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 GENERATOR
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FLEX; hamatechet 2; migdal haemek 23069 95; IS 2306995
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21746655
• Report Number: 2029046-2025-00999
• Device Sequence Number: 3862695
• Product Code: LPB
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)230725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: D138402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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: AFFERA ABLATION SYSTEM; UNKNOWN SALINE BAG
• Patient Sex: Unknown