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

Model Number	SSAX-16-I
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2007
Type of Reportable Event	Malfunction
Event or Problem Description
On or about (b)(6) 2007, plaintiff underwent placement of defendants' vortex port catheter device, with model number ssax-16-1, and lot number 27839.The vortex was implanted by dr.(b)(6), at (b)(6) hospital (b)(6).On or about (b)(6) 2007, plaintiff presented to (b)(6) hospital (b)(6) for removal of the vortex given the device was no longer needed and was not flushing properly.On or about (b)(6) 2007, dr.(b)(6) attempted to remove the vortex device, and while he was able to remove the port body itself, he discovered that the catheter portion of the device had fractured and migrated.Plaintiff underwent imaging, which confirmed a fragment of the fractured catheter remained in his body.On or about (b)(6) 2007, plaintiff presented to (b)(6) hospital in (b)(6) to undergo retrieval of the fractured catheter fragment.The retrieval procedure was performed by dr.(b)(6), and she was able to successfully retrieve the entire catheter fragment.
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: VORTEX
• 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: 24465480
• Report Number: 1319211-2026-00053
• Device Sequence Number: 10308307
• Product Code: LJT
• UDI-Device Identifier: H787SSAX16I0
• UDI-Public: H787SSAX16I0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2007
• 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): 06/03/2026

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: SSAX-16-I
• Device Lot Number: 27839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/03/2026
• 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: Male