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

Catalog Number	D133601
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 15-jan-2026, additional patient and event information was received.The information received indicated the physician¿s opinion on the cause of this adverse event was the transseptal puncture.The outcome of the adverse event was reported as fully recovery.The patient required extended hospitalization because of monitoring the patient during recovery.No sheath or catheters exchanges occurred during the procedure.One transseptal puncture site was performed during the procedure with a merti needle.The number of performed radiofrequency (rf) (energy source) ablations was 55.The ablations were performed in the left and right coronas.The flow settings were 2ml and 30ml.The patient did not require cardiac surgery.The correct catheter settings were selected on the smartablate generator.No issues with flow rate change at the start of ablation.No error messages were observed on biosense webster equipment during the procedure.The force visualization features used were graph, dashboard, vector, and visitag.The visitag module parameters for stability used were from 300 to 500ai and 3mm visitag size.The additional filter used with the visitag was ct scan segmented with adas using the wall thickness.Lot number was also provided as 31759916m.Based on lot number availability, the device manufacture date and expiration dates were received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
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.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.Manufacturer's ref.# (b)(4).
Event or Problem Description
A patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with thermocool smarttouch catheter and the patient experienced cardiac tamponade treated with pericardiac puncture.It was reported that at some point a cardiac tamponade occurred.The surgery was not delayed due to the reported event, and the procedure was successfully completed.No fragments were generated.The medical intervention provided was pericardiac puncture.Multiple attempts have been made to gain clarification and additional information about this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
Additional Manufacturer Narrative
A patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with thermocool smarttouch catheter and the patient experienced cardiac tamponade treated with pericardiac puncture.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31759916m and no internal actions related to the complaint were found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23991991
• Report Number: 2029046-2026-00043
• Device Sequence Number: 13389240
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: (01)10846835008982
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• 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,Followup

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: D133601
• Device Lot Number: 31759916M
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 02/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/11/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MERTI TRANSSEPTAL NEEDLE.; SMARTABLATE GENERATOR SPARE-WW.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White