MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP, US CONFIGURATION; 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	06/18/2024
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.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 flutter left (l-afl) ablation procedure with a ngen pump and multiple times during the procedure, while ablating the left atrium, the ngen would cut off ablation.An error "high flow mismatch" was displayed on the ngen.They had to restart with a new lesion to continue using the foot pedal.No adverse patient consequence was reported.
Additional Manufacturer Narrative
On 18-jun-2024, additional information was received, and it was indicated that the generator was on automatic mode.The correct catheter settings were selected on the generator.No service is needed.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.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
It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with a ngen pump and multiple times during the procedure, while ablating the left atrium, the ngen would cut off ablation.An error "high flow mismatch" was displayed on the ngen.They had to restart with a new lesion to continue using the foot pedal.No adverse patient consequence was reported.The hardware investigation has been completed.No failure was found.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 johnson & johnson medtech's quality process.Correction to the initial report: full udi has been populated to 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 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: 19747028
• Report Number: 2029046-2024-02369
• Device Sequence Number: 15707239
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472(11)230922
• 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
• Report Date (Section B): 12/05/2024

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: 06/18/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 11/12/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/26/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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 RF GENERATOR, US; QDOT MICRO, BI, TC, D-F; UNK CABLE; UNK_CARTO 3
• Patient Sex: Unknown