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	06/30/2025
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 lot number: 31626710l 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.Manufacturer's ref.#: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch sf and the patient experienced cardiac tamponade that required pericardial drainage and prolonged hospitalization.Ablation was performed as usual, and there was almost no pericardial effusion immediately after the procedure, allowing the patient to return to the room.Later that night, a decrease in blood pressure was observed and pericardial effusion was confirmed.They waited until morning to perform pericardium puncture (approximately 500 ml of blood was drained).The specific timing and dates include: on june 30, ablation was performed.That night, a decrease in blood pressure and pericardial effusion were observed.On july 1 at 9 am, pericardium puncture was performed.The patient recovered, however, required extended hospitalization.The physician's opinions on the relationship between the event and the product is that there were no actions during the ablation that would cause tamponade.No abnormalities were observed prior to or during use of the product.Additional information was later received indicating the physician¿s opinion on the cause of this adverse event was that there was no manipulation that could cause cardiac tamponade during ablation.The intervention provided was pericardiocentesis.The patient was reported as fully recovered.Transseptal puncture was performed with rf needle.Prior to noting the pe, ablation was performed.The patient did not require cardiac surgery.
Additional Manufacturer Narrative
On 4-aug-2025, additional information about the patient and event were received.It was indicated the procedural activated clotting time (act) was around 300 seconds.No other relevant history/pre-existing condition provided.No catheter exchanges occurred during the procedure.One transseptal puncture site was performed during the procedure.There was no evidence of steam pop.The irrigation flow setting used for catheter was default.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: 22596569
• Report Number: 2029046-2025-02432
• Device Sequence Number: 11767059
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)280430(10)31626710L
• 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

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: 31626710L
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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: RF NEEDLE.; UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian