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	Chest Pain (1776); Muscle Weakness/Atrophy (1967); Sepsis (2067); Tachycardia (2095)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, plaintiff underwent placement of an angiodynamics smartport port catheter product, with model number h787ct96stsa0, and lot number 5842032.This smartport devices consisted of a port body and a polyurethane catheter.The smartport device was implanted by dr.(b)(6)md., at (b)(6) medical center, (b)(6), for the purpose of ongoing chemotherapy treatment.On (b)(6) 2025, plaintiff (b)(6) presented to (b)(6) medical center, (b)(6), with complaints of chest pain, generalized weakness, and sinus tachycardia.A sepsis alert was activated and a sepsis protocol initiated, after which plaintiff was diagnosed with sepsis.
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: 50863274
• Report Number: 1319211-2026-00316
• Device Sequence Number: 10715458
• Product Code: LJT
• UDI-Device Identifier: 15051684018050
• UDI-Public: 15051684018050
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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 Expiration Date: 12/31/2025
• Device Model Number: H787CT96STSA0
• Device Catalogue Number: CT96STSA
• Device Lot Number: 5842032
• 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: 02/13/2025
• 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: Other; Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female