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

Model Number	H787CT96STSD0
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Chest Pain (1776); Discomfort (2330); Neck Pain (2433); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	05/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2016, plaintiff (b)(6) underwent an insertion of a right internal jugular vein central venous access port of an angiodynamics smartport port catheter product, model number ct96stsd, lot number 4987773.Upon information and belief, this smartport device consisted of a port body and a silicone catheter.The smartport was implanted at (b)(6).On or about (b)(6) 2016, plaintiff presented to (b)(6) hospital in (b)(6) for right arm swelling and discomfort, where she was ultimately diagnosed with right upper extremity deep vein thrombosis ("dvt") caused by her smartport device.Her treaters did not recommend removal of the device at that time, and instead plaintiff was treated by being placed on blood thinners for 6 months.Thereafter, the smartport device remained implanted, and plaintiff did not suffer further problems until on or about (b)(6) 2019, when she presented to lake regional hospital for right chest and neck pain caused by her smart port device, which was occluded and not working properly.Her smartport device was thereafter surgically removed on or about (b)(6) 2019, at (b)(6) hospital.
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: 50201616
• Report Number: 1319211-2026-00281
• Device Sequence Number: 13346436
• Product Code: LJT
• UDI-Device Identifier: 15051684018067
• UDI-Public: 15051684018067
• 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: 2016
• Device Explanted Year: 2019
• 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): 08/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: H787CT96STSD0
• Device Catalogue Number: CT96STSD
• Device Lot Number: 4987773
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2016
• 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; Other; Required Intervention; Hospitalization
• Patient Sex: Female