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

Catalog Number	D138402
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
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.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) ablation procedure which included the use of a ngen generator and when immediately starting ablation, and after stopping ablation with the foot pedal, the flow rate still uses the low flow rate instead of normal high flow rate with ablating.Additional information was received which indicated that the pump stayed at 4ml of flow pre-ablation and for the entire duration of ablation.The pump never reset to baseline 2ml of flow before the next lesion start.It never achieved high flow at 15ml during ablation even as temperature approached and surpassed the max temp setting.Therefore, only power was titrated during ablation and not flow rate.There were no errors on the ngen generator nor on carto.No adverse patient consequence was reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter (afl) ablation procedure which included the use of a ngen generator and when immediately starting ablation, and after stopping ablation with the foot pedal, the flow rate still uses the low flow rate instead of normal high flow rate with ablating.Additional information was received which indicated that the pump stayed at 4ml of flow pre-ablation and for the entire duration of ablation.The pump never reset to baseline 2ml of flow before the next lesion start.It never achieved high flow at 15ml during ablation even as temperature approached and surpassed the max temp setting.Therefore, only power was titrated during ablation and not flow rate.There were no errors on the ngen generator nor on carto.No adverse patient consequence was reported.Hardware investigation details: technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for evaluation.The service was declined, as the issue was not presented anymore.No further investigation on this device was performed.A device history record evaluation was performed for the finished device number 23400168fg, and no internal actions related to the reported condition were identified.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).

• Brand Name: NGEN GENERATOR
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 21981966
• Report Number: 2029046-2025-01476
• Device Sequence Number: 20910986
• Product Code: OAD
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)231005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010068
• 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): 07/02/2025

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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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 PUMP, US CONFIGURATION.; UNK_CARTO 3.; UNK_QDOT MICRO.
• Patient Sex: Unknown