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

Catalog Number	D134801
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
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 lot number 31626474l 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).
Event or Problem Description
It was reported that a patient underwent a right ventricular outflow tract (rvot) for premature ventricular contraction (pvc) ablation procedure with a thermocool smarttouch sf catheter and suffered a cardiac tamponade and administered noradrenalin and protamine.Required prolonged hospitalization.In the procedure, after performing approximately five ablations just below the pulmonary valve, a decrease in blood pressure was observed while attempting to move the thermocool smarttouch sf catheter over the pulmonary valve.Echocardiography confirmed effusion.The effusion was minimal.The sedation was discontinued and after administering noradrenalin and protamine, the patient's blood pressure recovered within about 30 minutes.No drainage was performed.The patient returned to the room.Timing was approximately 2 hours from the start of the procedure.Atrial septal puncture was not performed.Ablation was performed before pericardial effusion was identified.Steam pop was not observed.Irrigation catheter¿s flow rate setting was default.The physician assessment of the health problem was non-serious (moderate/minor).Prolongation of hospital stay was confirmed.The contact force (cf) monitoring methods were real time graph, dashboard, vector, and visitag.The coloring setting of visitag was tag index.No abnormalities observed prior/during use of the product.Additional information was received on 30-sep-2025.The patient¿s hospital stay was extended by one day for observation purposes.The patient has already been discharged.The physician¿s commented that although believed to be a procedure-related issue, the timing of the onset of cardiac tamponade was unknown.Additional information was received on 02-oct-2025.The outcome of the adverse event was fully recovered (no residual effects).The catheter exchanges that occurred during the procedure were one catheter used for each.The transseptal puncture was not performed.The energy delivered was radio frequency (rf).The event occurred during ablation phase.No evidence of a steam pop.The patient did not require cardiac surgery.No error messages were observed on biosense webster equipment during the procedure.Additional information was received on 07-oct-2025.The procedural act was 300 seconds over.The number of performed ablations was 5 ablations.No ablations were performed within the pulmonary veins, and 5 ablations on right ventricle outflow tract (rvot).The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.

• 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: 23354550
• Report Number: 2029046-2025-03511
• Device Sequence Number: 18442233
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)280423(10)31626474L
• 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): 10/21/2025

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: 31626474L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: OPTRELL, 36 ELECTRODES, D-F; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; UNK_CARTO 3; UNK_SMARTABLATE PUMP
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Female
• Patient Race: Asian