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	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent and idiopathic ventricular tachycardia ablation procedure with a thermocool smarttouch sf catheter and the patient experienced cardiac tamponade that required pericardiocentesis.A pericardial effusion around the right ventricle was noticed.While ablating in the right ventricular outflow tract (rvot), the catheter displayed on the carto 3 system jumped and slid outside of the fast anatomical mapping where it should have been.The pericardial effusion was confirmed with intracardiac echocardiogram.The procedure was aborted.The medical intervention provided was pericardiocentesis.The patient was monitored with ultrasound for about 10 minutes to confirm that the pericardial effusion did not return.The physician¿s opinion on the cause of this adverse event were the ablations were in the anterior rvot, which is thinner.The outcome of the adverse event was that the patient is fully recovered.The patient required extended hospitalization because the patient was taken to the intensive care unit instead of the recovery room.The sheath and the catheter were exchanged once.No transseptal puncture was performed during the procedure.Six ablations were performed with radiofrequency for all ablations.No ablations were performed within the pulmonary veins.No evidence of steam pop.The event occurred during ablation phase.The flow setting was 15 ml/min during ablation.The correct catheter settings were selected on the generator.The force visualization features used were graph, vector and visitag.The visitag module parameters used for stability were respiratory adjustment, minimum time was 3, fot was 25%, minimum force 3g, and tag size three.No additional filter was used with the visitag.The color options prospectively used was time.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot: 31716950l and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.However, if the product is received at a later date, the investigation will be updated as applicable.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
During an internal review on 25-jan-2026, noted a correction to the 3500a initial under the d10.Concomitant medical products and therapy dates section.Initially reported unk_ngen rf generator and ngen pump.However, should have been reported as ngen rf generator, us and ngen pump, us configuration.Therefore, updated d10.Concomitant medical products and therapy dates section.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: 24024607
• Report Number: 2029046-2026-00098
• Device Sequence Number: 10583473
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(17)280820(10)31716950L
• 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): 01/26/2026

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: 31716950L
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: CARTO 3 SYSTEM; NGEN PUMP; NGEN PUMP, US CONFIGURATION; NGEN RF GENERATOR, US; UNK_NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White