MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN GENERATOR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D138402
Medical Device Problem Codes	Smoking (1585); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen generator and they heard a loud audible noise that came from the vicinity of the ngen generator.They went to ensure the generator was functioning properly.They then noticed that the ngen generator was powered off completely and a "lost communication with ngen" message appeared on the carto 3 system.They powered on the ngen generator and the ngen generator made a loud "boom" noise.It was noted that the ngen began to spark and smoke.The reporter did not personally see any fire or flames; however, the nurse standing next to the reporter stated that she saw sparks.They could just smell the smoke and it smelled like something was burning.The ngen system was powered down and unplugged from the power source.The case continued without the use of the ngen.No adverse patient consequence was reported.
Additional Manufacturer Narrative
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.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 an atrial fibrillation (afib) ablation procedure with a ngen generator and they heard a loud audible noise that came from the vicinity of the ngen generator.They went to ensure the generator was functioning properly.They then noticed that the ngen generator was powered off completely and a "lost communication with ngen" message appeared on the carto 3 system.They powered on the ngen generator and the ngen generator made a loud "boom" noise.It was noted that the ngen began to spark and smoke.The reporter did not personally see any fire or flames; however, the nurse standing next to the reporter stated that she saw sparks.They could just smell the smoke and it smelled like something was burning.The ngen system was powered down and unplugged from the power source.The case continued without the use of the ngen.No adverse patient consequence was reported.Hardware evaluation details: according to the work order information, the console was replaced to solve the problem.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.Correction to the initial report: the h 4.Device manufacture date has been updated.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, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FLEX; hamatechet 2; migdal haemek ; IS
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21370281
• Report Number: 2029046-2025-00409
• Device Sequence Number: 20962133
• Product Code: OAE
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)240109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• 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): 05/13/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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: SOUNDSTAR ECO GE 8F CATHETER.; UNK_CARTO 3.; UNK_QDOT MICRO.
• Patient Sex: Unknown