MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR; SIMILAR DEVICE M490007, PMA # P990071/S017

Catalog Number D138401

Device Problems Unintended Power Up (1162); Failure to Power Up (1476)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an ngen rf generator, us configuration.The pedal was released but the ablator ablated on his own for around 3 seconds.It was reported that they had issue with the ngen and the carto during the procedure.They got the following error messages on the ngen : error 207 occurred during ablation, they released the pedal but the ablator ablated on his own during for around 3 seconds and it stopped on its own, they did not stop the ablation manually.The issue happened after a few ablations were already done.Error 210 ¿power up sequence¿ also occurred and yhey restarted the system (only ngen) and it solved the issue.Procedure completed.No patient consequences.15 minutes delay reported.Foot pedal ablation with no manual pressure is mdr-reportable.Start up error is not mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: they got the following error messages on the ngen ; error 207 ¿ during ablation, they released the pedal but the ablator ablated on his own during 4 or 5 seconds.They had to stop the ablation manually.Error 210 ¿ ¿power up sequence¿ they restarted the system (only ngen) and it solved the issue.Remote support confirmed that the unit is performing as intended.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

On 29-sep-2022, the product investigation was completed based on remote support performed by a company representative.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an ngen rf generator, us configuration.The pedal was released but the ablator ablated on his own for around 3 seconds.Device evaluation details: remote support confirmed that the unit is performing as intended.A device history record evaluation was performed for the finished device number fg20350040, and no internal actions related to the reported complaint were identified.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
• Type of Device: SIMILAR DEVICE M490007, PMA # P990071/S017
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15143629
• MDR Text Key: 304878745
• Report Number: 2029046-2022-01762
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• 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?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2020
• 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: CARTO 3 SYSTEM