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

Model Number	CT80LPPDVI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Chest Pain (1776); Dyspnea (1816); Pleural Effusion (2010)
Date of Event	11/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2022, decedent underwent placement of the angiodynamics port, reference number (b)(4), lot number 5732866.The device was implanted by (b)(6), for the purpose of ongoing chemotherapy.On or about (b)(6) 2022, decedent presented to (b)(6) 2024, with complaints of chest pain and shortness of breath.Decedent was diagnosed with pleural effusion and an infection.Due to decedent's positive blood cultures, her medical team determined that the defective port had to be removed and should not be replaced.On or about (b)(6) 2022, dr.(b)(6), m.D., removed decedent's defective port at (b)(6).
Additional Manufacturer Narrative
The reported complaint description of 'patient infection' cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port device was returned for evaluation.In addition, there was no report of port/catheter device malfunction, damage or performance issue during device use.A device history record (dhr) review of the indicated packaging/assembly/component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Sterilization load release records for device packaging lot were reviewed, with no issues observed.Labeling review: the directions for use (dfu) item number 14600340-01 that is provided in the reported kit contains the following directions and precautions: contraindications · presence of infection, bacteremia, or septicemia.Warnings · the device is to be implanted, used, maintained and removed in accordance with current evidence-based guidance for infection prevention from agencies/organizations such as centers of disease control (cdc) or the world health organization.It is recommended that institutional policies and procedures are updated periodically to reflect current evidence-based guidelines for infection prevention.· contamination of the device may lead to injury, illness or death of the patient.Precautions · carefully read and follow all instructions prior to use · after implantation or usage of the port, the system should be flushed to clear infusates and/or blood components in order to maintain patency.· if more than one drug is to be administered, between the individual drug applications, flush the system with 5 to 10 ml normal saline for injection to prevent drug interaction.Potential complications · bacteremia · catheter thrombosis · death · inflammation · infection · thromboembolism · thrombophlebitis · tunnel infection · vascular thrombosis 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: BIOFLO 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: 20903848
• Report Number: 1317056-2024-00251
• Device Sequence Number: 18405392
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPPDVI0
• UDI-Public: H787CT80LPPDVI0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: CT80LPPDVI
• Device Lot Number: 5732866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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; Hospitalization; Required Intervention
• Patient Sex: Female