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	04/22/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen pump.When radiofrequency (rf) energy was applied to the qdot micro catheter, the power setting did not climb as suspected.They removed the catheter, and it was found that the irrigation was turned off to the catheter.The irrigation was turned back on to the catheter and it irrigated properly.The catheter was reinserted and when rf energy was applied, the power settings performed as suspected.There was no indication from the ngen pump (no error/alert) that the catheter was not irrigating properly.No adverse patient consequence was reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen pump.When radiofrequency (rf) energy was applied to the qdot micro catheter, the power setting did not climb as suspected.They removed the catheter, and it was found that the irrigation was turned off to the catheter.There was no indication from the ngen pump (no error/alert) that the catheter was not irrigating properly.Technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for evaluation.After several communications between clinical account specialist and technical services, it was noticed that the irrigation tube was not connected to the catheter.After securing connection, catheter functioned appropriately.The event reported by the customer was confirmed.The root cause is related to user, as the catheter was not properly connected to the device.The user cannot start ablation until the irrigation is initiated.In this case, the pump and the generator were performing as expected: the pump had no irrigation errors and the irrigation was initiated as usual.Then, the generator met the threshold to interrupt ablation; the temperature was not decreasing due to the pump not being connected to catheter irrigation port.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.The manufacture date in h4 and udi in d4 have been updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (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: 22041786
• Report Number: 2029046-2025-01605
• Device Sequence Number: 9280415
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472(11)230513(21)091123-120
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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: QDOT MICRO, BI, TC, D-F.; SOUNDSTAR ECO CABLE ASSY 10 FT.; UNK_CARTO 3.
• Patient Sex: Unknown