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

Model Number	H787CT80STPD0
Medical Device Problem Codes	Difficult to Flush (1251); No Flow (2991)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/15/2015
Type of Reportable Event	Malfunction
Event or Problem Description
On or about(b)(6) 2014, plaintiff underwent placement of an angiodynamics smartport port catheter product, model number ct80stpd, lot number 475663.The smartport was implanted on the right side of her chest by dr.Summer thomas, md, at unity healthcare in lafayette, in.On or about (b)(6), 2015, plaintiff presented to franciscan health in lafayette east after experiencing continued complications and pain associated with the use of her implanted smartport during chemotherapy treatment.When medical staff attempted to administer chemotherapy through the smartport, they were unable to obtain blood return or properly flush the device, both of which are recognized signs of an occluded implanted venous access port.The smartport was surgically removed from the plaintiff's body on (b)(6), 2015.
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: 50201602
• Report Number: 1319211-2026-00282
• Device Sequence Number: 10274923
• Product Code: LJT
• UDI-Device Identifier: 15051684018036
• UDI-Public: 15051684018036
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H787CT80STPD0
• Device Catalogue Number: CT80STPD
• 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
• 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
• Patient Sex: Female