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

Catalog Number	D134701
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation with a thermocool smarttouch catheter and the patient experienced a stroke.A patient who had a pvi (pulmonary vein isolation) ablation procedure on (b)(6) had a stroke on (b)(6).The procedure was initially mapped with varipulse, but due to the la (left atrium) anatomy the physician decided to continue mapping with pentaray and do the ablation with stsf catheter.No ablation with varipulse was performed.The physician's opinion on the cause of the adverse event is patient condition.Procedural act (activated clotting time) was >300.There was no evidence of thrombus/clot/char during the procedure.It was reported that patient had a symptomatic stroke and the symptoms are ongoing.Patient required extended hospitalization.The patient does not have history of previous stroke.
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).
Additional Manufacturer Narrative
On 3-apr-2026, the product investigation was completed as the complaint device was not returned.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.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.Additionally, it was identified per internal review on 22-apr-2026 that the following statement was mistakenly omitted from h11: "d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available." 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: 24702167
• Report Number: 2029046-2026-00986
• Device Sequence Number: 10046755
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: D134701
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8.5 FR VARIPULSE CATHETER; 8.5F SHEATH WITH CURVE VIZ SMC
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown