MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, JAPAN; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D138404

Device Problem Failure to Pump (1502)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

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.However, the catheter used in this case is currently unknown, therefore no pma details are available.Follow-up was performed and no additional information was provided.Therefore, this file is processed with the ablation catheter information of the smart touch sf.The hardware investigation has begun but it has not been completed at this time.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 Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with an ngen generator and despite reaching target temperature, the flow rate did not change and slight ¿w¿ titration was observed.The issue occurred before the 17th ablation during left pulmonary vein isolation (lpvi).The ablation was not consecutive and there was an interval between the 16th and 17th ablation.The pump was in automatic mode at the time.Since the flow rate changed without any problem during subsequent ablations, no action was taken.Ablation was not stopped.The procedure was successfully completed.The procedure was completed without patient's consequence.

• Brand Name: NGEN RF GENERATOR, JAPAN
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 19053655
• MDR Text Key: 340131029
• Report Number: 2029046-2024-01141
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• 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: 03/12/2024
• 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: UNSPECIFIED IRRIGATION PUMP