MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO VORTEX; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	H787CT80LPBDNFVI0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Chest Pain (1776); Extravasation (1842)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On or about (b)(6), 2022, plaintiff underwent placement of an angiodynamics 8f smartport product, reference number (b)(4), lot number 5743897.The device was implanted by dr.David c.Lynn, md at (b)(6) hospital in (b)(6) wisconsin, for the purpose of providing chemotherapy administration.On or about (b)(6), 2023, plaintiff was admitted to (b)(6) hospital for chest wall pain.During her extended hospital stay, plaintiff's smartport was found to have port leakage and fibrin sheath of the port catheter that required port removal and replacement.On or about (b)(6), 2023 following plaintiff's diagnosis, plaintiff's defective port was removed at (b)(6) hospital by dr.(b)(6) m.D.On or about (b)(6), 2023, plaintiff underwent placement of an angiodynamics 8f smartport product, reference number (b)(4), lot number 5748718.The device was implanted by dr.(b)(6), m.D.At (b)(6) hospital wisconsin, for the purpose of providing chemotherapy administration.
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.Reference (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: 24728675
• Report Number: 1319211-2026-00104
• Device Sequence Number: 13328344
• Product Code: LJT
• UDI-Device Identifier: 15051684017145
• UDI-Public: 15051684017145
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K190559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: H787CT80LPBDNFVI0
• Device Catalogue Number: CT80LPBDNFVI
• Device Lot Number: 5743897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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
• Patient Sex: Female