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	Stroke/CVA (1770)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool smarttouch sf catheter and suffered a cerebrovascular accident which required prolonged hospitalization.The patient experienced cerebral infarction and details were unknown.The cerebral infarction developed on postoperative day 2 (on (b)(6) 2025) and the patient was being followed up.Finger paralysis persists at present.The physician¿s assessment regarding health hazard was not-serious (moderate/mild).Extended hospitalization was noted.Cf monitoring methods were dashboard, vector, and visitag.The visitag coloring setting was tag index.The physician¿s comment on the relationship between the event and the product was that it was this procedure, rfa (cti) was performed with thermocool smarttouch sf catheter, and pfa (pvi, box) was performed with pulse select (medtronic).The physician has not identified a direct cause but suspects it may be related to pfa.Since the sheath was replaced, air embolism is also being considered.No abnormalities observed prior/during product use.Additional information was received on 17-nov-2025.The physician reported that the patient who underwent ablation procedure using carto 3 system on (b)(6) 2025, developed cerebral infarction on postoperative day 2 (on (b)(6) 2025) and required treatment.Additional information was received on 20-nov-2025.The adverse event occurred on 14-nov-2025.The energy source used when the adverse event occurred were both pfa and radio frequency (rf) used during the procedure.The pfa was performed with medtronic pulseselect.The catheter exchanges that occurred during the procedure were one catheter used for each.The ablations performed within the pulmonary veins were only pulsed field ablation (pfa) with medtronic pulseselect.Cavotricuspid ishmus (cti) ablation was performed by rf.The force sensing ablation catheter used was thermocool smarttouch sf.The neurological impairment event was cerebrovascular accident (cva) / stroke.The patient¿s symptoms did not resolve and the patient still had finger paralysis.Additional information was received on 07-dec-2025.Additional intervention was provided, but details were unknown.The outcome of the adverse event was improved.The finger paresis seen in the acute phase is improving.The patient was still in the hospital.The procedural act was 350-400 seconds over (measured value: high).The catheter exchanges during the procedure were one catheter was used for each.One transseptal puncture site was performed during the procedure.The visitag module parameters for stability used were range: 5mm, time: 3sec, fot: 25%3g, tag size: 3mm.No additional filter was used with the visitag.The neurological impairment event was cerebrovascular accident (cva) / stroke diagnosed with mri.The patient¿s symptoms did not resolve.The patient still has finger paralysis and was not discharged from the hospital yet.No evidence of char or blood/thrombus /clot during the procedure.
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: 31587493l 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.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).

• 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: 23798711
• Report Number: 2029046-2025-04139
• Device Sequence Number: 13078348
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)280305(10)31587493L
• 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
• Report Date (Section B): 12/13/2025

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: 31587493L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2025
• Initial Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: MEDTRONIC PULSE SELECT.; OCTA, STD, 48P, 2-2-2-2-2, D-CURVE.; SMARTABLATE GEN. KIT (JAPAN).; SMARTABLATE PUMP KIT (JAPAN).; SOUNDSTAR ECO SMS 8F CATHETER.; UNK SHEATH.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Race: Asian