MAUDE Adverse Event Report: AngioDynamics, Inc. Smart Port CT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	H787CT96STSA0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pneumonia (2011); Sepsis (2067)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2024, plaintiff underwent placement of an angiodynamics smartport port catheter product, with model number h787ct80stpd0, and lot number 5821731.This smartport device consisted of a port body and a polyurethane catheter.The smartport device was implanted by dr.(b)(6) md.Under the supervision of dr.(b)(6) md., at (b)(6), for the purpose of ongoing chemotherapy treatment.On or about (b)(6) 2025, plaintiff (b)(6) presented to (b)(6) hospital in (b)(6), with complaints of fever since that morning.She was admitted with concern for neutropenic fever with sepsis and hospital- acquired pneumonia.Blood cultures from the port were positive for staphylococcus epidermidis likely contaminant at port site.Blood cultures drawn on (b)(6) 2025, from the port site, were positive for staphylococcus epidermidis in 1 of 2 bottles.Found to have methicillin resistant staphylococcus epidermidis bacteria in one bottle.On or about (b)(6) 2025, medical recommendation was to discontinue vancomycin given negative mrsa nares swab.Continue cefepime.Discontinue blood culture collection.The assessment at the time was that patient is colonized or contaminant at port site vs low concern for clabsi.Plaintiff continued her hospital stay until (b)(6) 2025, when she was finally discharged.
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: Smart Port CT
• 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: 50863273
• Report Number: 1319211-2026-00317
• Device Sequence Number: 10715457
• Product Code: LJT
• UDI-Device Identifier: 15051684018050
• UDI-Public: 15051684018050
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: H787CT96STSA0
• Device Catalogue Number: CT96STSA
• Device Lot Number: 5821731
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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: Life Threatening; Required Intervention; Other; Hospitalization
• Patient Sex: Female