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	09/17/2025
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 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 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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro catheter and an ngen generator and suffered an esophageal pericardial fistula which required an esophagus patch and the pericardial sac flushed.The patient had an esophageal pericardial fistula.The fistula did not go all the way to the atrium.The patient went into the emergency room (er) in (b)(6) 2025 about 2-3 weeks following the procedure.Unable to provide details about the patient symptoms and unsure what specific date the patient came into the er.The event was reported to the jnj representative on (b)(6) 2025.Fluid was noticed in the thoracic space.It was unknown how the injury was confirmed, and more testing was performed.The esophagus was patched up and the pericardial sac had to be flushed out a few times.The patient's pericardial sac had to be flushed out because the fistula in the esophagus was leaking fluid and acids into the pericardial sac.The last known patient status was alive and discharged.A qdot micro catheter was used for ablation.Qmode plus was used.The ngen generator was used for ablation and carto 3 system was used for mapping.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.This adverse event was assessed as mdr reportable under both the qdot micro catheter and the ngen generator.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro catheter and an ngen generator and suffered an esophageal pericardial fistula which required an esophagus patch and the pericardial sac flushed.The investigation was completed on 09-dec-2025.Technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for evaluation.No failure was found during the evaluation.Account has done several cases with the ngen since incident without issue.Customer did not ask for a system check.System is ready for clinical use.Other circumstances may have affected device performance.System is fully operational.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.As part of the quality process, the devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 06-nov-2025.Confirmed that at the time he initially called on 21-oct-2025, he was in a case and had to drop the call.Therefore, called the following day 22-oct-2025 to provide the remaining information on the event.The patient went into the er about 3 weeks after the procedure date of (b)(6) 2025.Did not have the exact event date and therefore provided oct 2025.It did not penetrate deep enough to go into the atrium; therefore, the event was an esophageal pericardial fistula.Does not have lot or catalog # for the qdot micro catheter since it was 3 weeks after the procedure.The specific date of the event was 17-sept-2025.The physician¿s opinion on the cause of this adverse event was using qdot on the posterior wall.The intervention provided was the esophagus was patched, and pericardial sac of the heart was flushed out multiple times.The outcome of the adverse event was improved.The patient required extended hospitalization because the patient was in the intenisve care unit (icu) for an extended period.Relevant tests/laboratory data was ct scan of chest showed fluid in pericardial space.After intervention barium swallow showed no leakage of esophagus to pericardial sac.Ngen generator was used in qmode plus.No error messages were observed on biosense webster equipment during the procedure.The modalities used to prevent esophageal injury was temperature probe.The esophageal injury confirmed that the patient went to the hospital and had fluid in the thoracic space.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.The carto 3 system did not indicate to re-zero the catheter.The force visualization features used were graph, dashboard, vector and visitag.The visitag module parameters for stability used was qmode plus.No additional filter was used with the visitag.Since the event date was provided of 17-sep-2025, processed b3.Date of event.Additionally provided the patient¿s sex, gender and weight.Hence, processed the following fields: -a3a.Sex.-a3b.Gender.-a4.Weight of the patient.-a4.Weight unit.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 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: 23453087
• Report Number: 2029046-2025-03673
• Device Sequence Number: 8057160
• Product Code: OAE
• UDI-Device Identifier: 10846835018080
• UDI-Public: (01)10846835018080(11)230824
• 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,Followup,Followup
• Report Date (Section B): 01/05/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 12/09/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/04/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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.; UNK_QDOT MICRO.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 137 KG