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

Catalog Number D138404

Device Problems Output below Specifications (3004); Protective Measures Problem (3015)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a ngen rf generator, japan configuration and the system continued to ablate below power setting minimum value for a few seconds.It was reported, when ablation was started, the output power was suppressed as temperature increased and the ablation was performing at 2 watts.Replaced the qdot micro catheter resolved the issue.Temperature was set to control mode.Target temperature 47¿, power 50w, impedance 50odown.The noted temperature was: 48-49¿, impedance: about 120o, power 50w.Ablation never continued beyond the cut-off temperature value.The physician stopped the ablation by foot switch at his discretion.The ngen rf generator, japan configuration system continued to ablate below power setting minimum value for about a few seconds.Since the power output was reported to be suppressed and the generator still delivered rf, the event has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

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.E1.Initial reporter phone: (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(6).

• Brand Name: NGEN RF GENERATOR, JAPAN CONFIGURATION
• 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: 18853157
• MDR Text Key: 337512583
• Report Number: 2029046-2024-00762
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 02/06/2024
• 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: JPN CARTO 3 SYSTEM; QDOT MICRO, BI, TC, D-F; QDOT MICRO, BI, TC, D-F