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	Heart Block (4444)
Date of Event	07/07/2025
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 lot number: 31528723l 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 reference number: (b)(4).
Event or Problem Description
It was reported that during a premature ventricular contraction (pvc) cardiac ablation procedure with a thermocool smarttouch sf catheter, and the patient experienced atrioventricular (av) block which required a pacemaker implantation.During pvc procedure, ablation was performed targeting at 9 o'clock position of the mitral valve.The ablation was conducted at 20w to 30w while confirming his potential from the his body surface side.Although the ablation was being proceeded carefully, av block occurred at the 30th ablation.The physician's assessment of health hazard was non-severe (moderate/mild).No extension of hospitalization.The physician's comment on the relationship between the event and the product was that this event was a shock (to the physician) because the ablation proceeded with caution as the location was with risks.The catheter position and contact force were not bad, so the physician did not think there was any problem with the product.More careful observation was needed.Visitag color setting was tag index.There were no abnormalities observed prior to or during use of the product.One catheter was used for each catheter exchange during the procedure.The energy delivered was radiofrequency (rf).Additional information was received which indicated that after detecting the patient¿s own pulse once, the condition worsened in the ward, and ultimately, a pacemaker was implanted.After the pacemaker implantation, the patient condition recovered and was discharged.
Additional Manufacturer Narrative
Additional information was received on 08-aug-2025.It was reported that there were three (3) transseptal puncture sites performed during the procedure.There were thirty (30) ablations performed outside the pulmonary veins and no ablations were performed within the pulmonary vein.It was also reported that a smartablate generator, as well as a smartablate pump were used.Therefore, the concomitant product section was updated.Also, patient details were provided; therefore, section a 3b.Gender and a 5.Ethnicity were populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 22690456
• Report Number: 2029046-2025-02508
• Device Sequence Number: 9045024
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(11)250122(17)280121(10)31528723L
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 31528723L
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: ACUNAV 8F-90; ACUNAV 8F-90; OCTA,STD,48P,2-2-2-2-2,D-CURVE; OCTA,STD,48P,2-2-2-2-2,D-CURVE; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN); UNK_CARTO 3; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian