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

Catalog Number	D138503
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	09/06/2025
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 ref.#: (b)(4).
Event or Problem Description
The patient underwent index ablation procedure with a vizigo the patient experienced postinterventional aneurysmal spurium at the right groin.On (b)(6) 2025, the adverse event start date, the patient experienced postinterventional aneurysmal spurium at the right groin (adverse event # 1) categorized as moderate and not serious.The relationship to the study device of qdot micro catheter was classified as not related.The relationship to the index study procedure is considered causal.The patient¿s outcome was reported as resolved with an end date on (b)(6) 2025.Intervention was other thrombin injection.
Additional Manufacturer Narrative
On 12-jan-2026, information was received providing additional products involved in the event that were classified as not related to the adverse event.All items have been added to section d10.Concomitant medical products.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
The patient underwent index ablation procedure with a vizigo the patient experienced postinterventional aneurysmal spurium at the right groin.Device investigation details: 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.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 5-mar-2026, additional information was received indicating the index procedure date was updated from (b)(6) 2025 to (b)(6) 2025.Additionally, the adverse event term was updated from postinterventional aneurysma spurium at the right groin to ¿postinterventional spurious aneurysm of the right superficial femoral artery¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 24016144
• Report Number: 2029046-2026-00069
• Device Sequence Number: 18787581
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)270618(10)00002967
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: D138503
• Device Lot Number: 00002967
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/25/2026; 03/05/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/29/2026; 03/02/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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 RF GENERATOR.; OPTRELL, 36 ELECTRODES, D-F.; QDOT MICRO, BI, TC, D-F.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 73 KG