MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAV; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Perforation (2513)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During cardiac ablation with ez steer thermocool nav catheter, the patient experienced drop in blood pressure, cardiac arrest, cardiac tamponade treated with cardiopulmonary resuscitation and drainage.After introducing percutaneous cardiopulmonary support, thoracotomy was performed and perforation was noted at the lateral side of the base of left ventricle.After completing ablation at the cusp, during premature ventricular contraction procedure, the patient's blood pressure dropped, leading to cardiac arrest, and cardiopulmonary resuscitation was initiated.Cardiac tamponade was reported and drainage was conducted, and vitals temporarily stabilized, but then deteriorated again.After introducing percutaneous cardiopulmonary support, thoracotomy was performed.The ablation sites were the cusp and near the left ventricular outflow tract, 25-30w for 60 seconds.Ablation catheter was a tc (tacticath by abott, so there was no contact force measurement).Visual impdrop indicator showed ablation, and during the final ablation, there was no excessive impedance decrease or increase.Extended hospitalization was noted.Visitag coloring setting was total time.The physician's opinions on the relationship between the event and the product judged from the blood gas results that the pericardial effusion was likely from the ventricular side.Since the only device placed on the ventricular side was the ablation catheter, the cause might be related to the ablation or catheter manipulation.No abnormalities observed prior or during use of the product.Carto 3 system was used for the procedure.Additional information indicated that the physician¿s opinion on the cause of this adverse event was pericardial effusion likely originated from the left ventricular side based on the investigation result of drained blood, and because the ablation catheter was the only device placed there, the issue may be related to the ablation itself or catheter manipulation.Ablation was performed using ez steer thermocool nav catheter.The location of the perforation was at the lateral side of the base of left ventricle.The intervention provided was drainage and percutaneous cardiopulmonary support (pcps) were performed and then the open chest surgery was conducted.The patient improved post-procedure and was weaned from pcps, but considering future needs, an impella was implanted.The outcome of the adverse event improved.Prior to noting the pe/ct ablation was performed.The event occurred after the completion of the ablation.There was no evidence of steam pop.No relevant tests/laboratory data or other relevant history/preexisting condition.An ngen generator was used during the procedure.Transseptal puncture was not performed.Initially, it was reported that the ablation catheter was a tc (tacticath by abott).Therefore, a notification was sent to the fda on 12-nov-2025 of abbott tacticath¿ contact force ablation catheter as the most suspected device.However, on 25-nov-2025, clarification was received which indicated that tacticath was not used, and only an ez steer thermocool nav catheter was used in this case as an ablation catheter.It was used during the event.
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.A manufacturing record evaluation was performed for the finished device lot number 31694610m and no internal action related to the complaint was found during the review.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).

• Brand Name: EZ STEER THERMOCOOL NAV
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23762449
• Report Number: 2029046-2025-04071
• Device Sequence Number: 18668297
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: (01)10846835003338(17)280710(10)31694610M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: BNI75TCDFH
• Device Lot Number: 31694610M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: NGEN PUMP, JAPAN CONFIGURATION; NGEN RF GENERATOR, JAPAN; TACTICATH BY ABOTT
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian