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

Catalog Number	D134804
Medical Device Problem Codes	Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch sf and an irrigation issue occurred during use in the patient.It was reported that after advancing the thermocool smarttouch sf catheter into the body and they started ablation, it was noticed that the irrigation flow rate for the thermocool smarttouch sf catheter was flowing at 2ml/min, compared to the normal 8-15ml/min flow rate.The caller advised that they were not inside the room at the time, and they were not able to confirm if the catheter setting for the thermocool smarttouch sf catheter had been changed or adjusted on the smartablate® pump.The caller then reported that the temperature reading on the tip of the thermocool smarttouch sf catheter had increased, until it was above 45 degrees.Upon removing the thermocool smarttouch sf catheter from the body, it was noticed that there was char residue on the tip of the thermocool smarttouch sf catheter.There was no consequence or injury to the patient.The thermocool smarttouch sf catheter was replaced, the caller confirmed that the thermocool smarttouch sf catheter flow setting was correct on the smartablate pump, and the issue was resolved.The procedure continued with no further issues.The caller declined any smartablate pump service at this time.
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 31776354l 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.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).

• 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: 25016134
• Report Number: 2029046-2026-01384
• Device Sequence Number: 10303080
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(17)281008(10)31776354L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31776354L
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/11/2026; 06/05/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/05/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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
• Patient Sex: Unknown