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

Catalog Number D138401

Device Problems Device Emits Odor (1425); Communication or Transmission Problem (2896); Protective Measures Problem (3015)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent the ventricular tachycardia (vt) procedure with a ngen rf generator, world wide configuration and a possible burning smell issue occurred.Initially it was reported that there was no communication between the ngen rf generator, world wide configuration and the console before the procedure.No harm on the patient.Additional information was received on 12-jan-2024.They also observed a possible burning smell when near the equipment.Additional information was received on 15-jan-2024.No fire or flames.No melting.No visual smoke, but it smelled like electrical over heating.The device did not start correctly.An irrigated catheter was used.Additional information was received on 18-jan-2024.Error 201 displayed.Leds are red.Replaced psu and had same outcome.Replaced console and had same outcome.With new psu and console, selftest does not pass.

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.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, no catheter information was provided.Follow-up was performed and no additional information was provided.Therefore, processed with the ablation catheter information of the smart touch sf.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent the ventricular tachycardia (vt) procedure with a ngen rf generator, world wide configuration.It was reported that there was no communication between the ngen rf generator, world wide configuration and the console before the procedure.No harm on the patient.Additional information was received.They also observed a possible burning smell when near the equipment.No fire or flames.No melting.No visual smoke, but it smelled like electrical overheating.The device did not start correctly.An irrigated catheter was used.Error 201 displayed.Leds are red.Replaced psu and had same outcome.Replaced console and had same outcome.With new psu and console, selftest does not pass.The console and the psu were defined as damaged on arrival (doa) and were replaced.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.H6: component code of ¿appropriate term/code not available" represents "damaged on arrival".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, WORLD WIDE CONFIGURATION
• 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: 18632073
• MDR Text Key: 334442514
• Report Number: 2029046-2024-00382
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NGEN PUMP, EU CONFIGURATION; UNKNOWN ABLATION CATHETER (IRRIGATED)