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

Catalog Number	D139702
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 pump and high flow would intermittently not go on.It was reported that when ablating with the qdot catheter, the fluid for the qdot catheter would intermittently not go to high flow, the temperature would rise and titrate the power readings displayed on the ngen monitor.The qdot catheter was reseated without resolution.The presets were switched on the ngen generator but the issue persisted.The caller used a default preset for the ngen generator without resolution.The power settings were changed from 40 to 45 on the ngen monitor but the issue persisted.The caller stated that when the issue would be noticed, they would come off ablation.The caller stated that when coming back on ablation, the issue would resolve temporarily.The procedure continued with the issue occurring intermittently throughout the case.There was no patient consequence.
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: for field d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not 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.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen pump and high flow would intermittently not go on.It was reported that when ablating with the qdot catheter, the fluid for the qdot catheter would intermittently not go to high flow, the temperature would rise and titrate the power readings displayed on the ngen monitor.The qdot catheter was reseated without resolution.The presets were switched on the ngen generator but the issue persisted.When the issue would be noticed, they would come off ablation.The caller stated that when coming back on ablation, the issue would resolve temporarily.The procedure continued with the issue occurring intermittently throughout the case.There was no patient consequence.Device evaluation details: according to the service report sent to johnson & johnson medtech, service was declined by the customer.No further analysis on the system was performed.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of the quality process.Note: the full udi has now been provided under field d4.Primary udi number.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 PUMP
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER, INC.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22376480
• Report Number: 2029046-2025-02146
• Device Sequence Number: 18199405
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S037
• 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

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: D139702
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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; PULSESELECT GENERATOR; UNK_QDOT MICRO
• Patient Sex: Unknown