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

Catalog Number D138401

Device Problems Insufficient Cooling (1130); Device Remains Activated (1525)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen rf generator, world wide configuration and the system did not stop ablating.It was reported that when ablating with a smartouch catheter when temperature reached the ¿cluster¿ value, the normal sound of the generator stopped and it wasn't clear if the generator was ablating or not.During an accessory pathway ablation.Managed to complete the case with the issue.No patient consequences.No delay.The generator was in power control, temp cut off was 50 degrees with a warning at 43 degrees.The noted power was 30w.Cut off values did not exceed.The foot pedal was not stuck but the system did not stop ablating.

Manufacturer Narrative

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.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 ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 10-oct-2023, it was noticed the event was incorrectly assessed as a reportable malfunction of the ngen rf generator did not stop ablation, however, the event has been reviewed and considered more likely a high temperature issue that is not considered to be mdr reportable since the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

• 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: 17909274
• MDR Text Key: 325405475
• Report Number: 2029046-2023-02272
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• 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: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NGEN PUMP, EU CONFIGURATION; UNK_SMART TOUCH BIDIRECTIONAL