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

Model Number	H787CT66LTPD0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Prior to 2024, plaintiff was diagnosed with breast cancer.Plaintiff's cancer treatment included chemotherapy.In order to administer chemotherapy medications, plaintiff's physicians placed a port catheter in her chest.On or about (b)(4) 2024, plaintiff underwent placement of an angio dynamics "smart port," identified as follows: upn: h787ct66ltpd0; lot number: al624008; manufacturer: angio dynamics, inc.The smart port was placed at (b)(6) in (b)(6) for purposes of administering plaintiff's chemotherapy.On or about (b)(6) 2024, plaintiff presented to (b)(6) with discomfort extending from the left side of her neck to her ear and shoulder region, down to the axilla, as well as a sensation of pressure at the site where the port had been placed.Plaintiff was diagnosed with acute embolism and thrombosis of the left subclavian vein, left axillary vein, and left internal jugular vein.(b)(4) ,1319211-2026-00322).On or about (b)(6) 2024, plaintiff was diagnosed with deep vein thrombosis ("dvt") and continued treatment with eliquis, 5 mg.(b)(4),1319211-2026-00323).On or about (b)(6) 2024, plaintiff underwent removal of the smart port at (b)(6).
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: 50876766
• Report Number: 1319211-2026-00323
• Device Sequence Number: 18498350
• Product Code: LJT
• UDI-Device Identifier: 15051684017978
• UDI-Public: 15051684017978
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 09/23/2026

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: H787CT66LTPD0
• Device Catalogue Number: CT66LTPD
• Device Lot Number: A1624008
• 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: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: Required Intervention; Other; Hospitalization; Life Threatening
• Patient Sex: Female