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

Model Number	H787CT50PTBDVI0
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a smartport single lumen mini titanium port removed in or on [redacted].X-ray obtained the next day on [redacted] showing a metal object in the chest area.Barrel that secures catheter to the port remains in the patient.On further inspection of other angiodynamics smartport kits, there is also concern of an unidentified piece that is free floating in the kits (all same lot numbers as removed port).Sometimes found loosely in the kit and one had this piece lodged in the syringe.It could create confusion on the purpose of this piece and whether or not it is supposed to be used with the device.

• Brand Name: BIOFLO VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 26 forest st; marlborough MA 01752
• MDR Report Key: 22318459
• Report Number: 22318459
• Device Sequence Number: 8812312
• Product Code: LJT
• UDI-Device Identifier: 15051684016674
• UDI-Public: (01)15051684016674(17)271031(10)5837284
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/22/2025
• Report Date (Section F): 05/22/2025

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 Model Number: H787CT50PTBDVI0
• Device Catalogue Number: CT50PTBDVI
• Device Lot Number: 5837284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 17 KG
• Date Report Sent to FDA: 05/22/2025