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

Catalog Number	D138402
Medical Device Problem Codes	Device Remains Activated (1525); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) procedure with ngen generator and when they tried to come off ablation with the remote stop button, ablation would not stop.There was an issue with the with ngen generator remote stop button mid procedure.When they tried coming off ablating, ablation would not stop.They had to press the stop button located in the front of the ngen generator remote multiple times to stop ablating.The procedure then continued without any further issues.There was no visible damage to the remote start button.Requested the start button to be repaired.Additional information was received.Ablation mode and thresholds; ngen- impedance cut off 250 and temperature cut off 40.The noted max temperature was 31, max impedance 240 and power 40.The cut off values were not exceeded.Foot pedal not in use.Ep lab technician had to press stop button multiple times before it would stop.
Additional Manufacturer Narrative
The investigation was completed on 03-jul-2025.It was reported that a patient underwent an atrial flutter (afl) procedure with ngen generator.There was an issue with the with ngen generator remote stop button mid procedure.When they tried coming off ablating, ablation would not stop.They had to press the stop button located in the front of the ngen generator remote multiple times to stop ablating.The procedure then continued without any further issues.Technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for evaluation.It was deemed that the remote monitor was causing the issue.After its replacement, the system worked as intended.No further evaluation on the remote monitor was performed.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.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: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22155130
• Report Number: 2029046-2025-01838
• Device Sequence Number: 7265969
• Product Code: LPB
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)240207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• 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,Followup
• Report Date (Section B): 07/28/2025

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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: CARTO 3 SYSTEM.; THMCL SMTCH SF BID, TC, D-F.
• Patient Sex: Unknown