MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, WORLD WIDE CONFIGURATION; CATHETER, ELECTRODE RECORDING

Catalog Number D138401

Device Problems Failure to Discharge (1169); Device Remains Activated (1525)

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

Event Date 07/15/2022

Event Type  malfunction  

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 4.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, the catheter used in this case, is not fda approved, therefore no pma details are available.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 atrial fibrillation (afib) ablation procedure with a ngen rf generator, world wide configuration and the pedal was not able to stop the radio frequency.The foot pedal was not working during the procedure (afib ablation using a qdot catheter).They got an error message (foot pedal error).The foot pedal was disconnected and reconnected and the issue had not been resolved.They rebooted the ngen rf generator, world wide configuration to manage and complete the procedure.There was no patient consequences.There was a 5 minute delay.The foot pedal error was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on 18-jul-2022.The issue was that the pedal was not able to stop the radio frequency release and an error was shown.A reboot was needed and then all worked fine.The additional information provided on 18-jul-2022 stating that the pedal was unable to stop the radio frequency was assessed as mdr reportable.The awareness date of this reportable issue is 18-jul-2022.

Manufacturer Narrative

The device evaluation was completed on 31-aug-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen rf generator, world wide configuration.The foot pedal was not working during the procedure (afib ablation using a qdot catheter).They got an error message (foot pedal error).The foot pedal was disconnected and reconnected and the issue had not been resolved.They rebooted the ngen rf generator, world wide configuration to manage and complete the procedure.There was no patient consequences.Additional information was received.The issue was that the pedal was not able to stop the radio frequency release and an error was shown.A reboot was needed and then all worked fine.The footswitch cable was damaged, so it was 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.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 13-oct-2022, the product investigation was reopened to clarify/correct the investigation findings which resulted in the following changes.The failure was not duplicated.However, the foot pedal cable was replaced as preventive maintenance, according to the customer request.Therefore, corrected the codes under h6.Investigation findings and h6.Investigation conclusions.H6.Component code should have been left blank.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-001162493 on 11-nov-2022, the product investigation was reopened to clarify/correct the investigation findings which resulted in the following changes.No further evaluation could be performed since additional service was declined.It was not possible to determine what caused the issue reported.Therefore, corrected the codes under h6.Investigation findings and h6.Investigation conclusions.

• Brand Name: NGEN RF GENERATOR, WORLD WIDE CONFIGURATION
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 15213313
• MDR Text Key: 305010255
• Report Number: 2029046-2022-01851
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNK_QDOT MICRO