MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN GENERATOR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D138402
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional 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 investigation was completed on (b)(6) 2025.Technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for analysis.No failure was found on the system.It was confirmed the ngen generator functioned without error and the system has been used successfully in multiple cases since.The system is ready for use.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 the quality process.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that 21 days after an atrial fibrillation (afib) radio frequency (rf) ablation with a qdot micro catheter and a ngen generator, the patient experienced an esophageal fistula treated with surgical repair.It was reported 21 days after the procedure, that the patient was admitted to the emergency room (er) with abnormal labs.The patient was taken to surgery and a "dime sized" esophageal fistula was found.The esophageal fistula was repaired within the operating room (or).The physician indicated that the patient was slowly recovering but remained in stable condition.The adverse event was assessed as mdr reportable under both the qdot micro catheter and the ngen generator.

• Brand Name: NGEN GENERATOR
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22835401
• Report Number: 2029046-2025-02739
• Device Sequence Number: 8850781
• Product Code: OAE
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)231019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: D138402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; QDOT MICRO, UNI, TC, F.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown