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

Catalog Number	BNI35BBH
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that the catheter ablation procedure was performed with a thermocool sf nav catheter to treat premature ventricular contraction and non-sustained ventricular tachycardia, the patient experienced premature ventricular contraction recurrence, and the catheter ablation was performed again.Coronary venography revealed occlusion in a part of a coronary vein.During the procedure itself, the right ventricular outflow tract, left ventricular outflow tract, and areas near the coronary veins were ablated, and a temporary suppressive effect was observed.After the procedure (unknown date), premature ventricular contraction recurred, and the catheter ablation was performed again.Coronary venography revealed occlusion in a part of a coronary vein.Although there were no clinical symptoms from the occlusion, ablation at the target site was difficult, so the procedure was discontinued.Definitive cure for premature ventricular contraction was not achieved.The physician's comment was that regarding the recurrence, since access to the earliest excitation site with the catheter was difficult, the ablation had to be performed at a proximal site.It may have contributed to an insufficient therapeutic effect and recurrence.Regarding the coronary venous occlusion, it is possible that the event was caused by the ablation near the coronary veins with the catheter.No extension of hospitalization.

• Brand Name: THERMOCOOL SF NAV
• 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: 23730088
• Report Number: 2029046-2025-04030
• Device Sequence Number: 13199189
• Product Code: LPB
• UDI-Device Identifier: 10846835003130
• UDI-Public: 10846835003130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S025
• 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): 12/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BNI35BBH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian