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	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 31413322l 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.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) cardiac ablation procedure with a thermocool smarttouch sf and 6 hours after the catheter was used, the patient experienced pericardial effusion/cardiac tamponade treated with drainage.Prolonged hospitalization was noted, and patient¿s vital signs stabilized.During pvc treatment, it was discovered that the cardiac motion was small while confirming fluoroscopy almost 6 hours after catheter use, and the accumulation of pericardial effusion/cardiac tamponade was confirmed using the sound star eco catheter.It was determined that the cause was not related to the products, and drainage was performed promptly.The vital signs stabilized.The physician¿s assessment of the health problem was that it was non-serious (moderate/minor).The physician's opinions on the relationship between the event and the product was there was no causal relationship.Prolongation of hospital stay was noted.Contact force (cf) visualization/monitoring methods included real time graph; dashboard; vector.Coloring setting of visitag was tag index.Additional filter for visitag was force over time (fot).No abnormalities were observed prior or during use of the product.The outcome of the adverse event was improved.The patient did not require cardiac surgery.Prior to noting the cardiac tamponade, ablation had already been performed.Catheter exchanges noted during the procedure was one catheter was used for each.No evidence of steam pop.
Additional Manufacturer Narrative
On 29-may-2025, additional information was received indicating a smartablate generator and smartablate pump were used during this case.Both items have been added to section d10.Concomitant medical products.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
On (b)(6) 2025, the physician¿s opinion on the cause of this adverse event is that it was patient condition related.The physician believed that the cause was the presence of a pectinate-muscle like gap at the anterior septum of the rvot, and the catheter might enter into the gap.The outcome of the adverse event was reported as fully recovered (no residual effects).The patient required extended hospitalization because of management and follow-up of cardiac tamponade.No transseptal punctures were performed during the procedure.The flow setting for irrigation were high flow 8-15ml/min, pre: 2 sec, and post: 5 sec.Correct catheter settings were selected on the smartablate generator.No issues with flow rate change at the start of ablation.Visitag module parameters for stability used were range: 3mm, time: 3sec, force over time (fot): 25%3g, and tag size: 2mm.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: 22064141
• Report Number: 2029046-2025-01655
• Device Sequence Number: 12715659
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)270904(10)31413322L
• 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,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: D134801
• Device Lot Number: 31413322L
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 06/06/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/02/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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; CARTO 3 SYSTEM; OPTRELL, 36 ELECTRODES, D-F; SOUNDSTAR ECO SMS 8F CATHETER; UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 60 KG