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

Catalog Number	D134703
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/29/2025
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 number lot 31542325l 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 a patient underwent a persistent atrial fibrillation ablation, and the patient experienced a stroke.After ablation, the patient was stable and was transported to the post op area.There, the patient exhibited signs of stroke.The patient was taken to imaging and magnetic resonance imaging (mri) was performed which confirmed a stroke.The patient remained stable and was discharged the next day.No intervention was done.The patient fully recovered (no residual effects).The patient required extended hospitalization consisting of an overnight stay.There was no evidence of char or blood thrombus/clot during the procedure.Correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.Activated clotting time (act) before and during ablation was 357 (only one act).There was one transseptal puncture site performed.The sheath was exchanged once, and the catheters were exchanged two times.There were twenty-six (26) pulsed field ablation (pfa) applications were done, with four (4) applications on the left atrial (la) roof, twenty-two (22) applications for pulmonary vein isolation (pvi), radiofrequency (rf) applications to cavo tricuspid isthmus (cti).There were no excessive intracardiac microbubbles nor excessive impedance errors noted during the case.The patient did not have any anatomical abnormalities.A stroke was confirmed, and mri and computed tomography (ct) scan were done.The findings from the mri showed scattered areas of acute infarction in the bilateral watershed zones of the cerebral hemispheres / bilateral occipital lobe infarcts.It was noted that the patient does not have a previous history of stroke.
Additional Manufacturer Narrative
Additional information was received which indicated that the irrigation rate was 4 (ml/min).It was also reported that the patient had persistent atrial fibrillation (psaf).The instructions for use (ifu) indicate this can increase risk.Pulmonary vein isolation (pvi) plus procedure, roof was ablated, ifu indicates this can increase risk.The thermocool smarttouch sf (stsf) was used in right atrium (ra) cavotricuspid isthmus (cti), in addition to varipulse.One case of insufficient movement, abl9-10, 171±22 ohm average impedance which appears to be in a normal range.The ifu indicates that stacking of ablations increases risk of injury.Note that some stacking was seen: three ablations in the right superior pulmonary vein (rspv) were performed with insufficient movement and in roughly the same orientation.Some veins received high doses of ablation: 8 to the left superior pulmonary vein (lspv) and 7 to the rspv, four is recommended as a baseline.Ensuring gap closure can reduce the total dosage required.Overall, the risk factors here involved: treating a psaf patient with a pvi+ approach with some stacking of ablation.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received which indicated that ablation was done while in atrial fibrillation.Vizigo was used.Activated clotting time (act) was greater than 350 seconds.Pre clot screening was done with transesophageal echocardiogram (tee).Protamine (50 u) was given after ablation.Concomitant product section was updated to include vizigo.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: 22350092
• Report Number: 2029046-2025-02109
• Device Sequence Number: 8527172
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: (01)10846835009798(17)280211(10)31542325L
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: D134703
• Device Lot Number: 31542325L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 07/31/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/28/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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; CARTO 3 SYSTEM; NGEN RF GENERATOR, US; NGEN RF GENERATOR, US; TRUPULSE GENERATOR, US; TRUPULSE GENERATOR, US; UNKNOWN_VARIPULSE; UNKNOWN_VARIPULSE; UNK_CARTO VIZIGO SHEATH; UNK_NGEN PUMP; UNK_NGEN PUMP
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: Black Or African American