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

Catalog Number	D134805
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia / left sided atrial flutter ablation with a stsf catheter (thermocool smarttouch sf) and the patient experienced pe (pericardial effusion) that required pericardiocentesis and surgical intervention.The patient also experienced cardiac arrest (pea - pulseless electrical activity) that required compressions.After they mapped the flutter, and started burning, the patient had moved.They had to re-initialize, make a new map and built fam, and started burning again.They were not sure on the location, and on ice (intracardiac echocardiography), it was displayed as if they were outside of the left atrium.The physician pulled the catheter back, and they noticed pressures dropped and noticed the effusion.The effusion was confirmed by using ice, looking at fam, pressure going to the manifold, and fluoroscopy.Pericardiocentesis was performed on the patient, and 200ml was drained.Emergency medical team (¿911¿) was called, and the patient did have pea (pulseless electrical activity) for a "little bit" and compressions had to be done.They got the patient back, finished draining, and the patient was then off to the hospital.Protamine and dopamine were also provided to the patient.The patient was alert, stable, and headed to the or (operating room) and the ct (cardiothoracic) surgeon was unable to find location of a perforation.A subxiphoid pericardial window was performed.The physician's opinion on the cause of the adverse event was that the patient moved during ablation.Relevant medical history includes previous atrial fibrillation history and prior ablation.The procedural activated clotting time was 342.There was one catheter exchange done during the procedure and one transseptal puncture site with an abbott brk-1 98cm needle.There were eleven radiofrequency ablations outside the pulmonary veins, and zero within pulmonary veins.Force visualization features used were graph, dashboard, vector, and visitag with parameters for stability 3g, 2.5s, 25% force, 3g.Additional filter used with the visitag was 5-30g, flash @ 30g.Green tip.Colored by impedance 0-10 ohm.Prior to noting the pe, ablation was performed.There was no evidence of steam pop.The event occurred during the ablation phase.The catheter flow setting was on stsf default irrigation settings.

• 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: 25460742
• Report Number: 3013300026-2026-01819
• Device Sequence Number: 10410063
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2026

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: D134805
• Device Lot Number: 31773073L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 07/14/2026; 08/10/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/20/2026; 09/02/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White