MAUDE Adverse Event Report: Biosense Webster Inc Dual Energy Thermocool Smarttouch SF Catheter; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Catalog Number	D134815
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Block (4444)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (af) ablation procedure with a dual energy thermocool smarttouch sf (stsf de) catheter and the patient experienced arrhythmia (junctional rhythm).During an af procedure with general anesthesia, they decided to do superior vena cava (svc) isolation with the stsf de with pules field ablation (pfa).They did mapping with pentaray during coronary sinus (cs) pacing and then did the ablation.After encircling the svc, they did a remap to check for isolation and then stopped pacing to check during sinus rhythm.However, when pacing was stopped, the patient did not have any rhythm, so they started pacing again.When pacing slower, a junctional rhythm emerged with a very few sinus beats in between.They then stopped the procedure.After the patient was awake, there was still junctional rhythm and no sinus rhythm.His heart rhythm slowing medications are now stopped and he'll receive a holter examination soon to see whether his sinus rhythm has come back.On (b)(6) 2026: sinus rhythm was restored in patient.The physician's opinion on the cause of the adverse event was that there was temporary stunning of sinus node tissue due to ablation with pfa in close proximity.It was also noted that the patient had experienced earlier temporary sinus node block.Patient did required extended hospitalization.
Additional Manufacturer Narrative
Device investigation details; an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field e1.Initial reporter phone: (b)(6).Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.# (b)(4).

• Brand Name: Dual Energy Thermocool Smarttouch SF Catheter
• 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): Biosense Webster Inc (Juarez); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50892949
• Report Number: 3013300026-2026-03160
• Device Sequence Number: 6001402
• Product Code: OAE
• UDI-Device Identifier: 10846835026917
• UDI-Public: (01)10846835026917
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial

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: D134815
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 286 LB
• Patient Race: White