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

Catalog Number	D134801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/16/2025
Type of Reportable Event	Death
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.The patient passed away under care.Physician's judgment on health hazard was serious.The physician's opinions on the relationship between the event and the product was that the cardiac tamponade occurred at some point during the manipulation of the thermocool smarttouch sf catheter.No extended hospitalization.The septal puncture was performed with rf needle.The visitag coloring setting was tag index.No abnormalities observed prior/during use of the product.Laboratory tests and results: pulmonary vein isolation for atrial fibrillation was complete.The atrial tachycardia was suppressed, but still inducible.Medical history/treatment history/other diseases currently being treated: the patient had a pacemaker implanted.Cavotricuspid isthmus ablation was performed during the initial ablation.There were no errors.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Since the date of death was not provided, processed date of death field as the event date of (b)(6) 2025.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 lot number 31708265l and no internal action related to the complaint was 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: (b)(4).
Additional Manufacturer Narrative
In the 3500a initial, under h11.Additional manufacturer narrative reported, ¿since the date of death was not provided, processed date of death field as the event date of (b)(6) 2025.¿ additional information was received on 11-nov-2025 confirming the date of death was (b)(6) 2025.Also, provided the following additional information.The physician¿s opinion of the cause of death were the procedure, cardiac tamponade, and the patient's pre-existing conditions were contributing factors to the death.During the thermocool smarttouch sf catheter manipulation, the contact force (cf) rose to 40g or more, and the sales representative issue warnings.When mapping using octa,std,48p,2-2-2-2-2,d-curve near the pacemaker leads, the sales representative again warned.The physician proposed that the mapping was performed under echocardiographic guidance, contouring the lead to identify its position, but he did not perform these steps.During the procedure, blood pressure dropped, noticed by the nurse and the (ce) clinical specialist.The physician performed transthoracic echocardiography to assess pericardial effusion but judged it to be within normal range and proceeded with the procedure.Ablation was performed at the left atrium (la) for pulmonary vein isolation (pvi) and at the right atrium (ra) lateral wall.After la pvi, atrial tachycardia (at) was induced and judged to be at originated from ra.To terminate the at, ablation was performed at the ra lateral site and annulus at the 1 o'clock position.It was still inducible, but because the overall voltage was low and the circuit could not be determined, the procedure was completed in sinus rhythm.Subsequently, the patient¿s blood pressure remained low; pericardial drainage was performed but hemostasis was not achieved.With persistent hypotension, percutaneous cardiopulmonary support (pcps), blood transfusion, and chest compressions were performed, but the patient passed away.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: 23511499
• Report Number: 2029046-2025-03756
• Device Sequence Number: 9785954
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)280520(10)31652122L
• 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,Followup
• Report Date (Section B): 12/09/2025

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: D134801
• Device Lot Number: 31652122L
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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: JPN CARTO 3 SYSTEM; OCTA,STD,48P,2-2-2-2-2,D-CURVE; RF NEEDLE.; SOUNDSTAR ECO SMS 8F CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 45 KG