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 Insufficient Heating (1287)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a ngen rf generator, japan configuration and a temperature issue with ablation occurred.During ablation, the temperature of the qdot micro catheter did not rise and the temperature on the bulls eye usually rose and turned red after 3-5 seconds of ablation, but this time the behavior was different from usual, and the bulls eye remained blue.There was no error number.The catheter was used as it was.No other generator was used.The procedure was completed without patient's consequence.Additional information was received on (b)(6) 2023.The temperature and impedance values were not noted.Power noted was 50w.The generator displayed less than generator lower cut off value prior to the start of ablation and ablation was able to be conducted.Unable to identify the root cause.No replacement was conducted and the procedure was completed remaining the issue unresolved.Repair was not required.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a ngen rf generator, japan configuration.During ablation, the temperature of the qdot micro catheter did not rise and the temperature on the bulls eye usually rose and turned red after 3-5 seconds of ablation, but this time the behavior was different from usual, and the bulls eye remained blue.There was no error number.The catheter was used as it was.No other generator was used.The procedure was completed without patient's consequence.Additional information was received.The generator displayed less than generator lower cut off value prior to the start of ablation and ablation was able to be conducted.The investigation was completed on 01-feb-2024.The service was declined.No further investigation could be performed, as it was not initially required.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: 18360736
• MDR Text Key: 331207288
• Report Number: 2029046-2023-02999
• 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,Followup
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: D138404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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: OPTRELL, 48 ELECTRODES, D-F.; QDOT MICRO, BI, TC, D-F.