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

Model Number	H787CT80LTBAVI0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Sepsis (2067)
Date of Event	02/18/2023
Type of Reportable Event	Death
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).
Event or Problem Description
On or about (b)(6) 2023, decedent g.W.Underwent placement of an angiodynamics smartport+ product, device identification number (b)(4), and catalogue number h787ct80ltbavi0.The device was implanted by dr.Marshall l.Dines, m.D., at advocate (b)(6, illinois, for the purpose of providing chemotherapy.On or about (b)(6) 2023, decedent g.W.Presented herself to the emergency department of advocate (b)(6) hospital illinois with a chief complaint of weakness, where she was diagnosed with sepsis.Decedent g.W.Was placed in the icu on (b)(6) 2023 and was pronounced deceased the same day.
Additional Manufacturer Narrative
The customer's reported complaint description of patient sepsis infection cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port device was returned for evaluation since there was no report of port device malfunction, damage or performance issue during use.A device history record (dhr) review of the ship history report (shr) packaging lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Sterilization load release records were reviewed for the packaging lots in question; no issues were observed.Labeling review: the direction for use (dfu) provided with the port device contains the following statements: 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 continues 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: 21674522
• Report Number: 1317056-2025-00080
• Device Sequence Number: 8311388
• Product Code: LJT
• UDI-Device Identifier: 15051684016827
• UDI-Public: 15051684016827
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/18/2025

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 Model Number: H787CT80LTBAVI0
• Device Catalogue Number: CT80LTBAVI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/23/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other; Death; Life Threatening; Hospitalization
• Patient Sex: Female