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 Perforation (2513); Intraoperative Cardiac Injury (4855)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an idvt (idiopathic ventricular tachycardia) ablation with a thermocool smarttouch sf and the patient experienced steam pop / vsd (ventricular septal defect) that required surgical intervention.It was reported that the there was a steam pop that occurred in the middle/end of the procedure.The physician stated they felt the steam pop occurred and the sc2000 ultrasound machine showed the tip of the catheter was "smokey" in that area.The medical team came off ablation right away and moved to a different location.It was originally reported that there was no injury to the patient and there were no other issues.The catheter was not replaced.Then it was discovered on (b)(6) 2026 that the patient suffered a vsd (ventricular septal defect) that was believed to have been caused by the steam pop.The patient was admitted to the hospital and the vsd was confirmed by echo.The patient underwent a vsd closure.The last known status was the patient was stable.Both rf (radiofrequency) and pfa (pulse field ablation) were used during the case.2 indifferent electrodes were used with rf.The stsf catheter was the ablation catheter used.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and revision of all device features were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to carto 3 system and an ablation cycle was performed, no force, magnetic, noise, temperature or impedance issues were found.Additionally, device was deflected and irrigated during the test and no issues were observed.A manufacturing record evaluation was performed for the finished device lot number: 31535591l and no internal action was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The instructions for use (ifu) states the following recommendations: when using the catheter with conventional systems (such as fluoroscopy or intracardiac echocardiography), with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement should be done under direct imaging guidance.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.As part of johnson & johnson medtech's 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50073268
• Report Number: 3013300026-2026-02436
• Device Sequence Number: 21362602
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(17)280121(10)31535591L
• 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
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 31535591L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown