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

Catalog Number	D134801
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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 pulmonary vein isolation (pvi) ablation procedure with a thermocool smarttouch sf catheter and suffered a cardiac tamponade which required drainage.The report indicated that after 2 hours of starting the pulmonary vein isolation (pvi) ablation procedure with thermocool smarttouch sf catheter, the patient's blood pressure decreased and cardiac tamponade was noted.Drainage was performed and the patient's blood pressure stabilized.The blood was described as venous-like in color.A decrease in blood pressure had been recorded immediately after the start of pvi, but it was unknown whether the blood pressure decrease was due to cardiac tamponade.The physician commented that while ablating the left atrium (la) roof with the thermocool smarttouch sf catheter there had been a timing when contact force became high due to respiration, and that this could not be excluded as a possible cause; however, the cause was unknown.The patient was able to converse.The physician assessment of the health problem was non-serious (moderate/minor).No prolongation of hospital stay was noted.The coloring setting of visitag was tag index.The additional filter for visitag was fot.The physician's opinions on the relationship between the event and the product was that there was no causal relationship with the product.The physician commented that the product had been the same as usual.No abnormalities observed prior/during use of the product.Additional information was received on 18-feb-2026.The outcome of the adverse event was that the patient improved.One catheter was used for each exchange.The energy delivered was radio frequency (rf).Prior to noting the cardiac tamponade (ct) ablation was performed.The patient did not require cardiac surgery.No error messages were observed on biosense webster equipment during the procedure.Additional information was received on 03-mar-2026.The outcome of the adverse event was fully recovered (no residual effects).Discharged date is unknown.One transseptal puncture site was performed during the procedure with nrg rf transseptal needle (baylis).The number of performed ablations was 78 with rf energy within the pulmonary veins.No ablations were performed outside the pulmonary veins.No evidence of steam pop.The flow settings were pre: 1sec and post: 5sec.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.The force visualization features used were cf, realtime graph, vector, and visitag.The visitag module parameters for stability used were stability+; time 3s, fot 25% 3g, and tag size 2mm.
Additional Manufacturer Narrative
It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool smarttouch sf catheter and suffered a cardiac tamponade which required drainage.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 31716616l 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 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: 24576074
• Report Number: 2029046-2026-00806
• Device Sequence Number: 9232625
• Product Code: LPB
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• 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): 03/11/2026

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: D134801
• Device Lot Number: 31716616L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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: 8.5F SHEATH, VIZ SMCURVE,SHORT; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SOUNDSTAR ECO GE 8F CATHETER; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian