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

Model Number	SSDX-16-I
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Arrhythmia (1721); Chest Pain (1776); Foreign Body In Patient (2687); Unspecified Heart Problem (4454)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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
On (b)(6) 2018, a vortex port catheter, lot #5131154 was implanted in plaintiff's left side chest.The procedure was performed by dr.(b)(6) at (b)(6) center.Plaintiff's port catheter was removed on or about (b)(6) 2023, by dr.(b)(6), at (b)(6) hospital of the, as it was no longer needed.At the time of the surgical removal on (b)(6) 2023, dr.(b)(6) had difficulty removing the vortex port.During the removal, a portion of the vortex catheter broke and remained in plaintiff's body, unbeknownst to dr.(b)(6) or plaintiff.For several weeks/months thereafter, plaintiff experienced left side chest pain, pleuritic, and palpations which would worsen when plaintiff laid on his left side.Plaintiff was treated for chest pain, palpitations and shortness of breath on (b)(6) 2023 at the hospital of (b)(6).In the course of his treatment in (b)(6) 2023, a ct was performed which showed "calcified right atrial mass seen on echo showing up on ct as retained fragment in left brachiocephalic vein".Due to the location of the retained fragment and the risk to plaintiff for an attempted removal of the fragment, the decision was made to leave the retained vortex fragment in plaintiff's body.To date, the retained fragment of the vortex remains in plaintiff's left brachiocephalic vein.As a result of having the vortex implanted, plaintiff has, allegedly, experienced significant mental and physical pain and suffering, and has suffered economic loss, including obligations for medical services and expenses.

• Brand Name: VORTEX
• 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: 20509246
• Report Number: 1317056-2024-00200
• Device Sequence Number: 9044234
• Product Code: LJT
• UDI-Device Identifier: H787SSDX16I0
• UDI-Public: H787SSDX16I0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 01/31/2022
• Device Model Number: SSDX-16-I
• Device Lot Number: 5131154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male