MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number	VS-404
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Blurred Vision (2137); Urticaria (2278)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Patient had one leg treated with venaseal on (b)(6) 2025.Eleven days later, on (b)(6) 2025, patient developed a full body allergic reaction, symptoms include generalised hives, itching, blurred vision, and shortness of breath.The patient was then sent to the eron (b)(6) 2025 and received steroids via iv.There was no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive during the procedure.Although, due to a vein spasm the physician had to access twice.45cm was treated with 2cc of adhesive.Vessel width was 5.3mm.Accessed at calf.The catheter tip was 5cm caudal to sfj.The gsv was compressed.The blue introducer was used.Issue has since resolved.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23320969
• Report Number: 9612164-2025-05122
• Device Sequence Number: 9938028
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: (01)00763000240776(17)261231(10)80526
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: VS-404
• Device Lot Number: 80526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 10/17/2025
• Date Device Manufactured: 12/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female