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

Model Number	H787CT75STSD0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
On or about (b)(6) 2015, plaintiff presented to (b)(6) hospital in (b)(6) to undergo left internal jugular placement of defendants' smartport product, with model number ct75stsd, and lot number 4824769.This smartport product is comprised of a port body and a silicone catheter.The implant procedure was performed by dr.(b)(6) pa-c, at (b)(6) hospital in (b)(6).On or about (b)(6) 2018, plaintiff presented to (b)(6) hospital in (b)(6), for a fluoroscopic port check as the smartport was malfunctioning.The port check revealed a catheter fracture with contrast extravasation, which would require removal of the smartport.On or about (b)(6) 2018, plaintiff presented (b)(6) hospital in (b)(6), to undergo removal of the smartport.The removal procedure was performed by dr.(b)(6), m.D.

• 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: 24562599
• Report Number: 1319211-2026-00063
• Device Sequence Number: 18474407
• Product Code: LJT
• UDI-Device Identifier: 15051684018005
• UDI-Public: 15051684018005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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 Expiration Date: 11/30/2017
• Device Model Number: H787CT75STSD0
• Device Catalogue Number: CT75STSD
• Device Lot Number: 4824769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 05/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2015
• 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