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

Model Number	H787CT75STSDVI1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
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.Reference: (b)(4).
Event or Problem Description
A nurse reported the following issue with a ct w/7.5fr det cath & vi smartport: "patient had an angiodynamics port placed by dr.(b)(6) on (b)(6).Patient arrived at the cancer institute on (b)(6).Port was accessed and no blood return noted.Cath flo was placed and unsuccessful.Md notified and portogram was ordered.Completed on (b)(6) and it showed: discontinuity of the patient's central catheter which appears to have sheared at the level of the chest wall.The loose fragment of the catheter is largely within the right atrium.Patient was then sent to the er and was transferred to gmh to have the device removed from right atrium." despite multiple good faith effort attempts, no further details have been obtained.
Additional Manufacturer Narrative
Supplemental report is being submitted due to additional information received in user facility medwatch; reference mw5178664.Additional information added to the following sections: a2; a4; a6; h10.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).
Additional Manufacturer Narrative
Follow up 2 emdr 1317056-2025-00337 was submitted on 4/24/2026.The report failed due to a duplicate report number.The follow up report incorrectly documented the section g6 follow up number as '1' instead of '2.' this is being sent to correct that error.Reference: (b)(4).

• Brand Name: SMART PORT CT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 23692422
• Report Number: 1317056-2025-00337
• Device Sequence Number: 10192318
• Product Code: LJT
• UDI-Device Identifier: 15051684018135
• UDI-Public: 15051684018135
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: H787CT75STSDVI1
• Device Catalogue Number: CT75STSD-VI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 04/24/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/19/2025; 04/29/2026
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: Black Or African American