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	Cardiac Tamponade (2226)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
The report indicated that after an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch sf (stsf), the patient experienced effusion that was treated with pericardiocentesis.The report indicated that after the procedure, a pericardial effusion was noticed.The intracardiac echocardiography (ice) catheter was rotated and noticed the effusion.The injury was visually confirmed on ice.Pericardiocentesis was performed on the patient, and the last known status of the patient was stable.At the time of reporting, it is unknown what caused the injury.Prior to the event, it was noted that the distal tip of the vizigo sheath rippled backwards while in the body.The sheath was removed from the body and the dilator was moved back and forth without resolution.The vizigo sheath was replaced, and the issue resolved.The procedure was continued.It was noted that the sheath was not related to the event, and the vizigo sheath and the stsf catheter were in use during the procedure.
Additional Manufacturer Narrative
The report indicated that after an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch sf (stsf), the patient experienced effusion that was treated with pericardiocentesis.The report indicated that after the procedure, a pericardial effusion was noticed.The intracardiac echocardiography (ice) catheter was rotated and noticed the effusion.The injury was visually confirmed on ice.Pericardiocentesis was performed on the patient, and the last known status of the patient was stable.At the time of reporting, it is unknown what caused the injury.Prior to the event, it was noted that the distal tip of the vizigo sheath rippled backwards while in the body.The sheath was removed from the body and the dilator was moved back and forth without resolution.The vizigo sheath was replaced, and the issue resolved.The procedure was continued.It was noted that the sheath was not related to the event, and the vizigo sheath and the stsf catheter were in use during the procedure.Device investigation details: the product was returned to johnson & johnson medtech (j&j) for evaluation on 26-may-2025.A visual inspection and revision of all features were performed following johnson & johnson medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed.No magnetic, force, irrigation, deflection, temperature or electrical issues were found during the product investigation.A manufacturing record evaluation was performed for the finished device 31556588l number, and no internal actions related to the reported complaint condition were identified.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of the johnson & johnson medtech 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 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: 22058463
• Report Number: 2029046-2025-01646
• Device Sequence Number: 7634758
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: (01)10846835009798(17)280131(10)31556588L
• 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
• Report Date (Section B): 06/19/2025

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: 31556588L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM; NGEN PUMP, US CONFIGURATION; NGEN RF GENERATOR, US; NON BWI LIVE WIRE CATHETER; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO GE 10F CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown