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	Cardiac Tamponade (2226)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia (at) procedure with a thermocool smarttouch sf catheter and suffered a cardiac tamponade which required a pericardiocentesis and drain placement.Immediately after the at procedure with thermocool smarttouch sf catheter, the blood pressure decreased.Transthoracic echocardiography confirmed accumulation of pericardial fluid/cardiac tamponade.Pericardiocentesis was performed and blood pressure normalized.The patient left the room and returned to the ward, and further courses will be followed later.The physician¿s assessment of health hazard was non-serious (moderate/minor), no extension of hospitalization noted.The physician¿s comment on relationship between the event and the product was that no relationship is considered.The event may have occurred while manipulating another company¿s catheter that had been placed in rv.The cf monitoring methods were dashboard and vector.The visitag coloring setting was tag index, and additional visitag filter used was fot.No abnormalities were observed prior/during product use.The outcome of the adverse event was improved.One catheter was used for each exchange.The energy used for ablation was rf.Additional information was received.The drain was removed on (b)(6) 2026.The patient was discharged on (b)(6) 2026.One transseptal puncture site was performed during the procedure.Two ablations were performed outside of the pulmonary veins.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31761665l 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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.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.

• 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: 24737485
• Report Number: 2029046-2026-01033
• Device Sequence Number: 15774652
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)280928(10)31761665L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/30/2026

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
• Device Lot Number: 31761665L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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: Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian