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

Catalog Number	D139702
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cryo atrial fibrillation procedure with an ngen pump.The bubble detector on the ngen pump was not beeping when bubbles were present during the high flow flashing and on high flow normal mode.They were able to flush out all the bubbles and continue with the case without any issues.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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).
Additional Manufacturer Narrative
The investigation was completed on 06-may-2025.It was reported that a patient underwent a cryo atrial fibrillation procedure with an ngen pump.The bubble detector on the ngen pump was not beeping when bubbles were present during the high flow flashing and on high flow normal mode.They were able to flush out all the bubbles and continue with the case without any issues.The device was received at a repair site for evaluation.Work order service report was sent to johnson & johson medtech for evaluation.The failure reported by the customer was not duplicated.Other circumstances may have affected device performance.Only minor cracks on top cover and overlay panel were found and properly repaired.These findings were not originally reported and are unrelated to the flow issue reported.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.H4.Device manufacture date has been added.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿air bubbles undetected¿ issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to component failure (d02) / component code: cover (g04037) and panel (g04096) were selected as related to the biosense webster inc.Analysis finding of the ¿minor cracks on top cover and overlay panel¿.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
During internal review on 29-may-2025, noted a correction to the 3500a follow-up #1 as should have included the d4.Primary udi number.Therefore, processed.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
During an internal review on 11-jun-2025, noted a correction to 3500a follow-up #2 under g3.Date received by manufacturer as reflected as 06-jun-2025 and should have been processed as 29-may-2025.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
• 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: 21001706
• Report Number: 2029046-2024-04099
• Device Sequence Number: 13221470
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472(11)231025
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/16/2025

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: 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: 11/26/2024
• Supplement Date Received by Manufacturer: 05/06/2025; 06/06/2025; 06/11/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 05/29/2025; 06/11/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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
• Patient Sex: Unknown