MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D134702
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an afib ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter, the patient experienced stroke.The patient was transferred to icu, and the following day, the patient had a second stroke.Additionally, 3 of the 4 thermocool smarttouch sf catheters had force error codes that was resolved with resetting the carto 3 system piu (patient interface unit).The information received indicated that during ablation procedure with a stsf and pentaray catheter used in the left atrium via an agilis steerable sheath from abbott.During the case (without biosense support) the medical team indicated that they had issues with the stsf catheter, and they couldn´t zero the catheter force and a force sensor error occurred on the carto system.Using normal troubleshooting routine, they changed the connection cable to a new one, but error remained.A new catheter was then tried successfully with a functioning force sensor.The second stsf catheter then had magnetic sensor warnings in carto, and it appeared in carto screen on normal desired position but rotated around its tip constantly.They again reconnected everything and made sure all connections were fine, but error remained.A new stsf from another lot was used, but the error also remained as the new catheter danced around its tip position.They then changed for another (4th) stsf catheter and restarted the piu - then everything was functioning as designed.The various issues took approximately 30 minutes to resolve.The procedure was completed, but it was discovered that patient had a stroke after waking up from anesthesia.The cause of the stroke is unclear.No charring was observed on catheter tip.The patient was transferred to icu and treated for acute stroke in normal clinical practice.No st elevation was found during procedure and no air embolism was found in stroke mri (magnetic resonance imaging) scan.The patient hemiparesis improved during the night, but the following morning the patient had a second stroke (for an unknown reason).The physician said it's plausible that the patient might not have taken anticoagulant medication regularly before procedure.The intervention provided was stroke protocol and mri scan.The strokes were treated routinely, and the patient was discharged at nearly fully recovered.The patient required extended hospitalization.The act (activated clotting time) during procedure was > 300s.One transseptal puncture site was performed during the procedure.The patient did not have previous history of stroke.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.The type of electrophysiology procedure being performed was new procedure.The arrhythmia treatment for this procedure was paroxysmal afib (paf).Before the procedure, the patient said that he was taking his anticoagulation regularly and patient came in for procedure in sinus rhythm and that was why the physician said an echocardiography to rule out laa (left atrium appendage) thrombi was not necessary.However, the patient later admitted that they were not taking their medication regularly.The physician then determined that the most plausible cause for the strokes was an incompliant patient that wasn´t taking his anticoagulation.The patient admitted that this was not regularly taken seriously.The finding from brain scans/mri was that there were no air embolisms.The patient did not have any anatomical abnormalities.No stacking occurred ablations sessions.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
On 30-oct-2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.During an afib ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter, the patient experienced stroke.The patient was transferred to icu, and the following day, the patient had a second stroke.Additionally, 3 of the 4 thermocool smarttouch sf catheters had force error codes that was resolved with resetting the carto 3 system piu (patient interface unit).Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and revision of all features were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device lot number 31704481l and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The root cause of the adverse event remains unknown.The instruction for use (ifu) contains the following warning and precautions: when using the catheter with conventional systems (using fluoroscopy to determine catheter tip location), or with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• 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: 23341214
• Report Number: 2029046-2025-03489
• Device Sequence Number: 7742814
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: (01)10846835009781(17)280725(10)31704481L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/16/2025

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: D134702
• Device Lot Number: 31704481L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2025
• 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.; CBL, 34 HYP/34 LEMO, 10'.; SMARTABLATE GENERATOR KIT-WW.; SMARTABLATE PUMP KIT-WW.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male