MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, JAPAN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D138404

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a ngen rf generator, japan configuration.When ablated at 50w, the flow rate at pre rf time was 4ml.The flow at 4ml flowed even though the temperature was maintained above max low flow temperature.Occurred reproducibly when continuous ablation was conducted in a situation where the previous ablation was completed at 4 ml.In the case where the previous ablation completed at 15 ml and in the case where continuous ablation was not performed, the behavior was normal, so the procedure was continued as it was.No other generator was used.The procedure was completed without patient's consequence.Additional information was received.The equipment allowed ablation when the issue occurred.No error., warning message.The correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.The irrigation pump setup was set to automatic mode.The qdot micro catheter was used.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Note: per fda request, mdr submissions for the ngen rf generator are to be reported with pma details of the catheter used along with the ngen rf generator.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a ngen rf generator, japan configuration.When ablated at 50w, the flow rate at pre rf time was (b)(4).The flow at 4ml flowed even though the temperature was maintained above max low flow temperature.The investigation was completed on 16-apr-2024.Remote support confirmed the unit was performing as intended; therefore, no failure was found with the system.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 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 RF GENERATOR, JAPAN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FLEX; hamatechet 2; migdal haemek ; IS
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18691947
• MDR Text Key: 335216614
• Report Number: 2029046-2024-00475
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK PUMP; UNK_QDOT MICRO