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

Model Number	H787CT80STPD0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Sepsis (2067); Medical device site infection (4845)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Prior to on (b)(6) 2020, plaintiff was diagnosed with cancer.The treatment for plaintiff's cancer included chemotherapy.In order to administer the chemotherapy medications to plaintiff, her physicians had a port-a-catheter placed in her right upper chest.On or about on (b)(6) 2020, plaintiff underwent placement of the following angiodynamics' port inf ct titanium 8fr, inventory item: port inf ct titanium 8fr implant name: port inf ct titanium 8fr - log280066 model/cat no.: h787ct80stpdo, manufacturer: angiodynamics, for the purposes of plaintiff's chemotherapy.On or about on (b)(6) 2020, the device at issue was implanted by (b)(6), md at (b)(6) center in (b)(6) for the purposes indicated above.The defendants, directly or through their agents, apparent agents, servants, or employees, designed, manufactured, marketed, advertised, distributed, and sold the port inf ct titanium 8fr that was implanted in (b)(6).Upon information and belief, on (b)(6) 2020, plaintiff presented to (b)(6) center in (b)(6) where plaintiff was seen for an extremely high fever and evidence of sepsis.On or about april, plaintiff was also treated for a suspected infection at the port site with antibiotics.Upon information and belief, plaintiff's port-a-cath at issue was removed due to the above, at (b)(6) center.
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 ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 23830615
• Report Number: 1319211-2025-00059
• Device Sequence Number: 9268409
• Product Code: LJT
• UDI-Device Identifier: 15051684018036
• UDI-Public: 15051684018036
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/17/2025

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: H787CT80STPD0
• Device Catalogue Number: CT80STPD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/17/2025
• 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
• Outcome Attributed to Adverse Event: Other; Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female