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 02/03/2024

Event Type  malfunction  

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.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.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 high flow rate activation problem with radio frequency issue occurred.When ablating at 36-50w in qmode, when ablation was completed, it was 4ml.If next ablation was started during post radio frequency (rf) time, when the above conditions were met, the pre rf time at the next ablation start (at 50w) started from 4ml and remained at 4ml, and only output titration was applied near the target temperature (47 degrees celsius).After the catheter moved, etc., the temperature fell below maximum low flow temp (42 degrees celsius) once, behavior returned to normal, and seemed to switch between 15ml and 4ml at the boundary of 42 degrees celsius.Timing of issue was during continuous ablation during post rf time.They completed the procedure successfully by continuing ablation while paying attention to the post rf time.No patient consequence reported.No other generator was used.Additional information was received stating the ablation never continued beyond the cut-off value.

Manufacturer Narrative

Additional information was received on 28-feb-2024.No error.The ablation never continued beyond the cut-off value.The flow rate was supposed to start at 15 mm above 36w but ended up starting at 4 mm.The flow returned to normal behavior when the max low flow temperature was lowered.The irrigation pump setup was set to automatic mode.Additional information was received on 08-mar-2024 providing the product information for the concomitant product of the originally reported unk_qdot micro.Therefore, updated the ¿d10.Concomitant medical products and therapy dates¿ section to qdot micro, bi, tc, d-f.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: 18793268
• MDR Text Key: 337553966
• Report Number: 2029046-2024-00650
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: QDOT MICRO, BI, TC, D-F.; UNK_CARTO 3.; UNK_QDOT MICRO.