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

Model Number	H787CT96STSDVI1
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	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received by 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
An end user reported an issue with a ct w/9.6fr detached sil cath & vi smartport, during a procedure.After the peel away dilator was inserted and upon removal the hub separated from the dilator, leaving it retained inside the peel away sheath.This was immediately noted by the scrub tech, who then alerted the physician, and the fragmented device was removed, without incident.The fragment remained inside of the sheath, at all times, and was not loose within the patient's body.The following procedure was completed with another same device and the patient did not experience any adverse effects or harm as a result of this event.
Additional Manufacturer Narrative
The customer's reported complaint description of the dilator tubing was detached from the hub was confirmed.(b)(4) and the returned complaint sample were sent to the valved introducer supplier/manufacturer, oscor, for complaint sample evaluation/root cause determination and a device history record (dhr) review of the reported lot number.Dhr review confirmed that all molding parameters were within the established specifications.A review of the materials used confirmed that all materials used correctly corresponded to the bill of materials.Root cause was determined to be a processing issue of dilator tubing not being pushed far enough onto core pin during the hub insert molding process.Oscor's quality procedure was updated to increase sampling plan for overmolding bond strength.In addition, the manufacturing procedure was updated to include visual aids for correctly and incorrectly seated units on the core pin.Personnel will be trained to procedure updates.Based on no adverse trends, no issues noted in the device history record review, and adequate process controls in place, no corrective action to be taken by angiodynamics at this time.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.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 ; 5086587990
• MDR Report Key: 21606287
• Report Number: 1317056-2025-00074
• Device Sequence Number: 21049871
• Product Code: LJT
• UDI-Device Identifier: 15051684018197
• UDI-Public: 15051684018197
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: H787CT96STSDVI1
• Device Lot Number: A4824060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown