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

Model Number	H787CT60LPBDNFVI0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Chills (2191)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's 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 since there was no report of port device malfunction, damage or performance issue during use.A device history record (dhr)/sterilization record review of the packaging lot could not be performed since there was no reported lot number.The port was implanted into the patient more than 7 months prior to the patient's infection.There was no report of port device malfunction or performance issue during use.If the manufacturing/packaging/sterilization of the port device in question was to contribute to an infection in the patient it would have likely occurred shortly after the implant date and not more than 7 months later.Device directions for use (dfu) cautions that each access of the port should be performed using aseptic technique, following the institutions universal precautions.There is no indication from the reported complaint that the manufacturing/packaging/sterilization of the port device could have contributed to the patient's infection.Infection is cautioned in the device dfu as a potential complication of port system use.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, catheter or port erosion through skin/vessel, death, inflammation, infection, implantation site necrosis or scarring of skin over implant area, thromboembolism, thrombophlebitis, tunnel infection, vascular thrombosis.Use and maintenance after implantation or usage of the port, the system should be flushed and locked to clear infusates and/or blood components in order to maintain patency.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).
Event or Problem Description
On or about (b)(6) 2022, (b)(6) underwent placement of an angiodynamics smartport product, ct60lpbdnfvi.The device was implanted by dr.(b)(6), do to be used for chemotherapy.On or about (b)(6) 2022, plaintiff presented herself to (b)(6) with a chief complaint of fever, hypotension, and chills, where she was diagnosed with sepsis related to port infection.

• Brand Name: BIOFLO 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: 24841557
• Report Number: 1319211-2026-00100
• Device Sequence Number: 9928704
• Product Code: LJT
• UDI-Device Identifier: 15051684017121
• UDI-Public: 15051684017121
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K190559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/10/2026

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: H787CT60LPBDNFVI0
• Device Catalogue Number: CT60LPBDNFVI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other; Life Threatening
• Patient Sex: Female