MAUDE Adverse Event Report: Biosense Webster Inc ThermoCool SmartTouch; Cardiac Ablation Percutaneous Catheter

Catalog Number	D132705
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a left sided nonischemic ventricular tachycardia ablation with a thermocool smarttouch catheter and the patient experienced a cardiac tamponade that required pericardiocentesis.The patient experienced a cardiac tamponade during the transseptal puncture.The cardiac tamponade stabilized by the physicians with a puncture.The procedure was successfully completed.It was reported that the thermocool smarttouch catheter was not involved according to the physicians.Additional information was received on 21-jul-2026 which indicated that the adverse event was discovered post use of biosense webster product.Seven radiofrequency ablations were performed outside the pulmonary veins.No ablations were performed within the pulmonary veins.A brk needle was used for the transseptal puncture.The flow setting was set to 0-30w 17ml/min, 30+w 30ml/min, low flow 2ml/min.After, received additional information on 21-jul-2026 which indicated that the sheath used for transseptal puncture was an agilis sheath.Ablation was performed prior to noting the cardiac tamponade.The adverse event was originally considered non-reportable under the thermocool smarttouch catheter as it was reported that the thermocool smarttouch catheter was not involved and that the event occurred during transseptal.However, bwi became aware on 21-jul-2026 that ablation occurred prior to the cardiac tamponade and therefore, the adverse event was reassessed as reportable under the thermocool smarttouch catheter.The awareness date for this record is 21-jul-2026.
Additional Manufacturer Narrative
G4.Pma/ 510(k): p030031;p040036.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).

• Brand Name: ThermoCool SmartTouch
• 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: 50328216
• Report Number: 3013300026-2026-02694
• Device Sequence Number: 5483206
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(17)290407(10)31904200M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: D132705
• Device Lot Number: 31904200M
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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; Life Threatening
• Patient Sex: Unknown