MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D134804
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right sided idiopathic premature ventricular contraction (pvc) ablation and the patient experienced a cardiac tamponade that required a pericardiocentesis and drain placement.During the procedure, the patient developed a pericardial effusion which was observed by a pressure drop and confirmed by trans thoracic echo.A pericardiocentesis was performed in which 500 cc's was removed from the pericardial space.The patient was reported to be stable and was transferred to the cardiac care unit (ccu) for observation.Additional information was received.Patient stayed overnight in the intensive care unit (icu) for drain management.The patient did not require cardiac surgery.The physician's opinion on the cause of the adverse event was perforation.The event occurred during mapping or ablation, ablation was performed prior to noting the adverse event.No transseptal puncture performed.No evidence of a steam pop.The correct catheter settings were selected on the generator.There were no issues with flow rate change at the start of the ablation.Other relevant patient history includes low ef (ejection fraction).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 02-mar-2026.The analysis has begun but is not 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.The manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a right sided idiopathic premature ventricular contraction (pvc) ablation and the patient experienced a cardiac tamponade that required a pericardiocentesis and drain placement.The device evaluation was completed on 19-mar-2026.The product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and revision of all features were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The potential cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of the quality process, all 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).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 24558936
• Report Number: 2029046-2026-00779
• Device Sequence Number: 10114656
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(17)281016(10)31773065L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: D134804
• Device Lot Number: 31773065L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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 RF GENERATOR, US.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic