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

Catalog Number	D138401
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an atrio-esophageal fistula (aef) occurred after an atrial fibrillation (afib) ablation procedure with a qdot catheter and ngen generator.It was reported that an aef was noticed in the patient.It is unknown what date the injury was discovered, or if it occurred during the atrial fibrillation case, how the aef was discovered, or how it was confirmed.The patient was observed under critical condition and required intervention extended hospitalization for observation.The patient was stable at the time of reporting.The information received indicated that the esophageal injury was confirmed.The number of performed ablations was 228 with radiofrequency energy delivered.The generator ablation mode used was qmode+ on posterior wall, and the force visualization features used dashboard, vector, and visitag.The visitag parameters for stability module used range 2-2.5mm and time 3-5sec.The additional filter used with the visitag was ablation index, with color option prospectively used was other tag index.The correct catheter settings were selected on the generator, and no issues with flow rate change at the start of ablation.
Additional 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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that an atrio-esophageal fistula (aef) occurred after an atrial fibrillation (afib) ablation procedure with a qdot catheter and ngen generator.It was reported that an aef was noticed in the patient.It is unknown what date the injury was discovered, or if it occurred during the atrial fibrillation case, how the aef was discovered, or how it was confirmed.The patient was observed under critical condition and required intervention extended hospitalization for observation.The patient was stable at the time of reporting.The information received indicated that the esophageal injury was confirmed.Device investigation details: technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for analysis.It was reported that no failure was found in the system.The work order was created for documentation purposes.System is working as intended.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 9-sep-2025, additional information was received indicating they don¿t have exact numbers of ablations delivere; but approximately around 200.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: 22852497
• Report Number: 2029046-2025-02762
• Device Sequence Number: 20926168
• Product Code: OAE
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)230215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: D138401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 09/09/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/05/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; UNKNOWN OCTARAY¿ CATHETER.; UNKNOWN WEBSTER® CS CATHETER.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Female