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

Catalog Number D138401

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 01/05/2024

Event Type  Death  

Manufacturer Narrative

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.The catheter used in this case is the qdot micro catheter.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).Biosense webster manufacturer's reference number (b)(4) has 2 reports.

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a ngen generator and a qdot-micro, bi-directional, d-f curve, c3, split handle and the patient experienced post-op esophageal fistula that resulted in death.The complication was declared several days/weeks after the intervention.The physician's opinion was that use of the qdot-micro contributed to the death but did not elaborate on the issue.The generator was in temperature control mode with a temperature cut off of 55°c.The correct catheter settings were selected on the generator.No error messages observed on biosense webster equipment during the procedure.When asked what modalities were used to prevent esophageal injury, the physician responded with: "temperature in the esophagus".The physician also stated that no perforations occurred during the procedure.This report is for the ngen rf generator.Another report has been submitted for the qdot catheter.

Manufacturer Narrative

On 31-jan-2024, bwi received additional information indicating that the previously reported event date of 8-jan-2024 is actually 5-jan-2024.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 16-apr-2024, the product investigation was completed as the customer confirmed that no generator malfunctions were reported and that servicing was not needed for the device.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.A device history record evaluation was performed for the finished device number (b)(6), and no internal actions related to the reported condition 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: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18599012
• MDR Text Key: 333989173
• Report Number: 2029046-2024-00319
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010068, P03
• 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,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D138401
• Device Lot Number: NGEN CONSOLE 2222 0022 DC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/31/2024; 04/16/2024
• Supplement Dates FDA Received: 02/21/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM WITH VISITAG; NGEN PUMP, EU CONFIGURATION
• Patient Outcome(s): Death; Life Threatening