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

Catalog Number	D139702
Medical Device Problem Code	Decreased Pump Speed (1500)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
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 fibrillation (afib) ablation procedure which included a ngen pump and the low fluid warning failed on the pump.They were not receiving a low fluid warning when the bag reached below the 100 ml level.The equipment allowed ablation when the issue occurred.There was no error or warning message about the fluid level on either the ngen monitor or the carto workstation.There was a bubble detected error by the pump which led them to realize the low fluid level.The correct catheter setting was selected, and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.Irrigation pump setup was automatic.The ngen generator was being used in power-controlled mode.No troubleshooting was performed.They replaced and reset the bag; however, they did not go below the threshold again.The issue remained unresolved.They declined any service or repair follow-up.No adverse patient consequence was reported.
Additional Manufacturer Narrative
Correction to the initial report: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a ngen pump and the low fluid warning failed on the pump.They were not receiving a low fluid warning when the bag reached below the 100 ml level.The equipment allowed ablation when the issue occurred.There was no error or warning message about the fluid level on either the ngen monitor or the carto workstation.There was a bubble detected error by the pump which led them to realize the low fluid level.The correct catheter setting was selected, and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.Irrigation pump setup was automatic.The ngen generator was being used in power-controlled mode.No troubleshooting was performed.They replaced and reset the bag; however, they did not go below the threshold again.The issue remained unresolved.They declined any service or repair follow-up.No adverse patient consequence was reported.Device investigation details: the unit was analyzed by technical services, following their procedures.They concluded that no failure was found on the unit.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster'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).
Additional Manufacturer Narrative
The hardware investigation has been updated including the h6 codes: as per work order, the reporter replaced the bag and declined the service.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster'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 PUMP, US CONFIGURATION
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19028505
• Report Number: 2029046-2024-01109
• Device Sequence Number: 7069170
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: 10846835017472
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 10/28/2024

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: Not provided
• Supplement Date Received by Manufacturer: 08/27/2024; 10/03/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: UNK_CARTO 3; UNK_NGEN RF GENERATOR; UNK_SMART TOUCH BIDIRECTIONAL SF
• Patient Sex: Unknown