MAUDE Adverse Event Report: AngioDynamics, Inc. BioFlo Vortex; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	H787CT80LPPDNFVI0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported an issue with a smartport 8f sl plastic non-filled det pu vi.A patient underwent internal jugular insertion of the port and received her first of four, chemotherapy treatments on (b)(6) 2026; consisting of docetaxel and cyclophosphamide.Palonosetron and pegfilgrastim were also delivered as supporting agents.Following the first chemotherapy treatment, the patient developed significant skin reactions and port site inflammation, leading to port removal on (b)(6) 2026, due to a suspected allergy.After port removal, the rash resolved and the patient tolerated the second cycle and g-csf injection without complications.Despite multiple good faith efforts, no further details have been obtained.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).

• Brand Name: BioFlo Vortex
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): AngioDynamics, Inc.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): AngioDynamics, Inc.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 603 queensbury avenue; queensbury, NY 12804
• MDR Report Key: 50189039
• Report Number: 1319211-2026-00276
• Device Sequence Number: 13249623
• Product Code: LJT
• UDI-Device Identifier: 15051684017206
• UDI-Public: 15051684017206
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K190559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2026

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 Model Number: H787CT80LPPDNFVI0
• Device Catalogue Number: CT80LPPDNFVI
• Device Lot Number: 5828725
• 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: 07/10/2026
• Initial Report FDA Received Date: 08/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female