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

Model Number	H787CT75STSD0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Fatigue (1849); Fever (1858); Chills (2191); Confusion/ Disorientation (2553); Medical device site infection (4845)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury

• 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: 50909990
• Report Number: 1319211-2026-00336
• Device Sequence Number: 20349629
• Product Code: LJT
• UDI-Device Identifier: 15051684018005
• UDI-Public: 15051684018005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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,Followup
• Report Date (Section B): 09/27/2026

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: H787CT75STSD0
• Device Catalogue Number: CT75STSD
• 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: 08/28/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/27/2026
• Supplement Report FDA Received Date: 09/27/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female