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

Catalog Number	D138402
Medical Device Problem Codes	Intermittent Continuity (1121); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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.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.However, no catheter information was provided.Follow-up was performed and no additional information was provided.Therefore, we are processing this mdr with the "qdot micro¿ catheter" which is the most commonly used ablation catheter with this system.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.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an ngen generator and the foot pedal became stuck.It was reported that a pedal stuck error (error 2) was being displayed on the ngen monitor.The caller stated that a low-flow mismatch error (error 52) was also displayed on the ngen monitor.The caller stated that the ngen pump was running at 15 ml.The ngen pump was rebooted and the issues were resolved.The procedure continued with no further issues.The ngen generator was used for ablation.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an ngen generator and the foot pedal became stuck.It was reported that a pedal stuck error (error 2) was being displayed on the ngen monitor.The caller stated that a low-flow mismatch error (error 52) was also displayed on the ngen monitor.The caller stated that the ngen pump was running at 15 ml.The ngen pump was rebooted and the issues were resolved.The procedure continued with no further issues.The ngen generator was used for ablation.There was no patient consequence.Device evaluation details: technical services performed remote evaluation of the device and the service report was sent to johnson & johnson medtech for analysis.No failure was found on the unit.Field service engineer contacted the bwi representative to discuss issues with foot pedal being stuck.The foot pedal stuck issues were resolved by stepping on foot pedal a couple times.A device history record evaluation was performed for the finished device number, 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 ref.# (b)(4).
Additional Manufacturer Narrative
On 25-jun-2025, additional information was received indicating a smart touch unidirectional sf ablation catheter was used.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.As such, the following fields have been updated as follows: d2a.Common device name has been updated from ¿catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation¿ to ¿cardiac ablation percutaneous catheter¿.D2b.Pro code has been updated from ¿oae¿ to ¿lpb¿.4.Pma/ 510(k) has been updated from ¿p210027¿ to ¿p030031/s078¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 22324775
• Report Number: 2029046-2025-02067
• Device Sequence Number: 15709086
• Product Code: LPB
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)230730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S078
• 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,Followup

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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/21/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/21/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NGEN PUMP, US CONFIGURATION.
• Patient Sex: Unknown