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

Model Number	H787CT80LPBDVI0
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Implant Pain (4561)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On or about on (b)(6) 2023, plaintiff underwent placement of an angiodynamics smartport product, reference number: ct80lpbdv1; lot number: 5777878.The device was implanted by dr.(b)(6), m.D., at (b)(6), for the purpose of providing chemotherapy.In and around on (b)(6) 2023, plaintiff was having problems with her portacath.On (b)(6) 2023, plaintiff presented herself to the (b)(6), with complaints that the smartport was not working.On or about on (b)(6) 2023, plaintiff was admitted for surgery for port manipulation and possible port exchange.Surgery was performed at the (b)(6), by dr.(b)(6).Anesthesia was monitored at all times during the surgery.The previous incision over the right chest area was opened and the medical team was able to reposition and not remove the smartport.The smartport was aspirated, flushed easily, and was secured to the chest wall.Plaintiff was transferred to the recovery room and tolerated the procedure well.On (b)(6) 2024, plaintiff presented herself to dr.(b)(6), at the (b)(6).Plaintiff stated that the smartport was again not working and was extremely painful during the infusions.Plaintiff was diagnosed with a dysfunctional port.In and around on (b)(6) 2024, dr.(b)(6), ordered a portagram to evaluate the portacath.The portagram indicated that the port catheter on her ride side was occluded.
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).
Additional Manufacturer Narrative
The customer's reported complaint description of the port system was occluded cannot be confirmed due to the patient centric nature of this adverse event.No port or catheter tubing product was returned to angiodynamics for evaluation.Catheter occlusion and fibrin sheath formation are cautioned in the device directions for use (dfu) as potential complication for an implanted port system.A device history record (dhr) review of the packaging/assembly/catheter lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/assembly/catheter lots for similar port/catheter occluded issue.The catheter and locking collar are provided as separate components within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with locking collar) during the implantation procedure.Labeling review: the directions for use (dfu) that is provided with the device contains the following statements: contraindications: presence of infection, bacteremia, or septicemia.Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.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.Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.If the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, fibrin formation, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure and patient injury may occur.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: catheter thrombosis.Catheter occlusion, malposition, dislodgement, fragmentation, migration, disconnection or rupture.Death.Fibrin sheath formation.Inflammation.Thromboembolism.Thrombophlebitis.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).

• 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: 23057194
• Report Number: 1317056-2025-00227
• Device Sequence Number: 15828629
• Product Code: LJT
• UDI-Device Identifier: 15051684016773
• UDI-Public: 15051684016773
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/23/2026

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: 04/30/2026
• Device Model Number: H787CT80LPBDVI0
• Device Catalogue Number: CT80LPBDVI
• Device Lot Number: 5777878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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
• Patient Sex: Female