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

Catalog Number	D134804
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	01/29/2026
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 number lot 31728719l 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.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 supraventricular tachycardia procedure with a thermocool smarttouch sf catheter and experienced that the patient went into complete heart block.The patient had no heart rhythm and confirmed this on ekg.The patient came out of heart block while stable and under observation and are two to one.The physician is putting a pacemaker in the patient, but the patient is conducting on their own.While ablating with the thermocool smarttouch sf catheter, it was noticed that the patient went into complete heart block.The patient had no heart rhythm and confirmed this on ekg.The patient came out of heart block while stable and under observation and are two to one.The physician is putting a pacemaker in the patient, but the patient is conducting on their own.The biosense webster, inc.Products in the body during the case were a webster coronary sinus catheter, thermocool smarttouch sf catheter, preface sheath, and two quad catheters (stryker reprocessed).The procedure was aborted.Additional information was received which indicated that the physician¿s opinion on the cause of this adverse event was that av node was burned.The intervention provided was temporary pacemaker, and permanent placed the next day.The outcome of the adverse event was unchanged.The patient required extended hospitalization but unknown the time.No transseptal puncture was performed during the procedure.The number of performed ablations was 7 with rf energy and all ablations were outside the pulmonary veins.No ablations were performed within the pulmonary veins.

• 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: 24421128
• Report Number: 2029046-2026-00616
• Device Sequence Number: 5917105
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(17)280828(10)31728719L
• 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
• Report Date (Section B): 02/23/2026

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: D134804
• Device Lot Number: 31728719L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• 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: CARTO® 3 SYSTEM.; NGEN¿ RF GENERATOR.; PREFACE SHEATH.; QUAD CATHETER STRYKER REPROCESSED.; QUAD CATHETER STRYKER REPROCESSED.; WEBSTER CS CATHETER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown