MAUDE Adverse Event Report: BIOSENSE WEBSTER INC VIZIGO; INTRODUCER, CATHETER

Catalog Number	D138505
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) cardiac ablation procedure with a thermocool smarttouch sf catheter and a vizigo sheath and suffered a cardiac tamponade which required drainage, thoracotomy and prolonged hospitalization.During the procedure for premature ventricular contraction (pvc) originating in the right ventricular outflow tract (rvot), while maneuvering the thermocool smarttouch sf catheter, a cardiac tamponade occurred.The event occurred while exploring after the catheter was inserted from the right atrium (ra) into the right ventricle (rv).Drainage was performed, and the patient¿s vitals improved.The rest of the procedure was performed using ablaze catheter (japan lifeline).No extended hospitalization.The relationship with the product was causal.The physician's opinion on the relationship between the event and the product was that when attempting to access the rvot with the vizigo sheath and the thermocool smarttouch sf catheter, cardiac tamponade might have occurred at the lesion where the contact force became high.The coloring setting for visitag was tag index.No abnormalities were observed prior/during use of the product.Additional information was received on 11-nov-2025.The outcome of the adverse event was improved.The energy source used when the adverse event occurred was radio frequency (rf) energy.Additional information was received on 18-nov-2025.The outcome of the adverse event was on the day of the procedure; thoracotomy was performed to achieve hemostasis.The patient's current condition was unknown.The patient required extended hospitalization.The adverse event was assessed as mdr reportable under both the thermocool smarttouch sf catheter and the vizigo sheath.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record evaluation was performed for the 60000505 finished device, and no internal actions related to the reported complaint condition were identified.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).
Additional Manufacturer Narrative
Additional information was received on 16-dec-2025.After drainage was performed during the procedure, the patient returned to the ward.On the day of the procedure, emergency thoracotomy was performed to achieve hemostasis.Subsequently, on (b)(6) 2025, a repeat ablation for premature ventricular contractions was performed.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: VIZIGO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FREUDENBERG MEDICAL LLC; 2301 centennial blvd; jeffersonville IN 47130
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23646164
• Report Number: 2029046-2025-03905
• Device Sequence Number: 17369279
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)260912(10)60000505
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170997
• 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): 01/13/2026

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 Expiration Date: 09/12/2026
• Device Catalogue Number: D138505
• Device Lot Number: 60000505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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: SMARTABLATE GEN. KIT (JAPAN).; SMARTABLATE PUMP KIT (JAPAN).; THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian