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

Catalog Number LVTX5213

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is not available to be returned to the manufacturer for analysis.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4) (1317056-2024-00068) port 1.Reference (b)(4) (1317056-2024-00069) port 2.

Event Description

(port 1) on or about (b)(6) 2019, plaintiff underwent placement of an angiodynamics vortex product at university of iowa.The device was implanted for the purpose of ongoing red cell exchanges and vein access.On or about (b)(6) 2022, plaintiff presented herself to the emergency department at (b)(6) with complaints of pleuritic chest wall pain.Plaintiff was also found to be febrile and therefore was transferred to mary greeley medical center in ames, iowa.Upon being admitted at (b)(6) medical center, plaintiff's blood cultures were drawn and were persistently positive.Plaintiff's medical team determined that the vortex was the source of the infection and that the defective port had to be removed.On or about (b)(6) 2022, plaintiff's defective port was removed by dr.(b)(6) at (b)(6) medical center in (b)(6).(port 2) on or about (b)(6) 2022, plaintiff underwent placement of an additional angiodynamics vortex product, reference number lvtx5213, lot number 5730316.The device was implanted by (b)(6) , m.D., at (b)(6) in (b)(6) , for ongoing red cell exchanges and vein access.On or about (b)(6) 2023, plaintiff's blood cultures were drawn and were positive for staph aureus.Plaintiff's medical team determined that the vortex was the source of plaintiff's infection and that the defective device had to be removed.On or about (b)(6) 2023, plaintiff presented herself to(b)(6) for port removal.After multiple defective devices, plaintiff made the decision to not have another port implanted.As a result of having the vortex implanted, plaintiff is alleging significant mental and physical pain and suffering, has undergone additional surgeries, and has suffered financial or economic loss, including, but to limited to, obligations for medical services and expenses.

• Brand Name: VORTEX
• Type of Device: PORT & CATHETER, IMPLANTED
• 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: 19153521
• MDR Text Key: 340794613
• Report Number: 1317056-2024-00069
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787LVTX52130
• UDI-Public: H787LVTX52130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LVTX5213
• Device Lot Number: 5730316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization; Other
• Patient Sex: Female