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

Model Number	P5455K
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	10/04/2013
Type of Reportable Event	Malfunction
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).
Event or Problem Description
On or about (b)(6) 2008, plaintiff underwent placement of defendants' vortex port catheter product, with model number p5455k, and lot number 31732.The device was implanted by dr.(b)(6), m.D., at (b)(6), alabama for long-term antibiotic therapy.On or about (b)(6) 2013, plaintiff presented to (b)(6), alabama to undergo a chest x-ray to evaluate plaintiff's dyspnea (shortness of breath), and the x-ray revealed catheter fracture.On or about (b)(6) 2013, plaintiff presented to (b)(6), alabama to undergo retrieval of a catheter fragment located in plaintiff's right atrium.The fragment retrieval operation was performed by dr.(b)(6), m.D.On or about (b)(6) 2013, plaintiff presented to (b)(6), alabama to undergo removal of the remaining vortex port catheter device.The procedure was performed by dr.(b)(6).

• Brand Name: 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 ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 24293997
• Report Number: 1319211-2026-00032
• Device Sequence Number: 15786087
• Product Code: LJT
• UDI-Device Identifier: H787P5455K0
• UDI-Public: H787P5455K0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• 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): 05/28/2026

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 Model Number: P5455K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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