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

Model Number	H965440320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	02/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's reported complaint description of patient thrombosis 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 lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the direction for use (dfu) that is provided with the port device contains the following statements: contraindications: presence of infection, bacteremia, septicemia or peritonitis.Warnings: the device is to be implanted, used, maintained, and removed in strict accordance with institutional and or centers for disease control (cdc) guidelines or policies.Precautions: carefully read and follow all instructions prior to use.After implantation and after any treatment via the port, the system should be flushed with normal saline for injection per institutional protocol 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 interactions after any infusion, injection or bolus application, the system should be flushed with normal saline for injection or locked with a heparin solution per institutional protocol to prevent thrombotic occlusion of the catheter.Bioflo ports with the pasv valve may be locked with either normal saline or heparinized saline per institutional protocol.Adverse events: bacteremia, catheter thrombosis, inflammation, infection, implantation site necrosis or infection, thromboembolism, thrombophlebitis, tunnel infection.Maintenance: to help prevent clot formation and catheter blockage, the xcela plus port should be filled with sterile heparinized saline after each use.Xcela plus ports with the pasv valve may be flushed and locked with either normal saline or heparinized saline per institutional protocol.If the port remains unused for long periods of time, the lock should be changed at least once every four weeks.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) 2021, plaintiff underwent placement of an angiodynamics xcela power injectable port catheter product, with model number h965440320, and lot number 5645799.The device was implanted by dr.(b)(6), m.D., at (b)(6).The device was implanted for the purpose of chemotherapy to treat plaintiff's breast cancer.On or about (b)(6) 2022, plaintiff presented to adventhealth ocala in ocala, florida, with complaints of leg swelling and swelling in the right arm and in the chest, as well as chest wall pain.Based on plaintiff's symptoms, plaintiff's treating medical providers ordered a neck ct, which plaintiff underwent on (b)(6) 2022, which revealed catheter-associated thrombus at the right superior vena cava as well as occlusion of the superior vena cava.Plaintiff was subsequently diagnosed with superior vena cava (svc) syndrome and thrombosis of the right-sided chest port.On or about (b)(6) 2022, plaintiff underwent removal of the xcela port secondary to the diagnoses of thrombosis and svc syndrome.The removal procedure was performed by dr.(b)(6), m.D, at (b)(6).

• Brand Name: XCELA
• 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: 22464943
• Report Number: 1317056-2025-00173
• Device Sequence Number: 8094218
• Product Code: LJT
• UDI-Device Identifier: 15051684018821
• UDI-Public: 15051684018821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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 Expiration Date: 09/30/2023
• Device Model Number: H965440320
• Device Catalogue Number: 44032
• Device Lot Number: 5645799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/09/2025
• 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; Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown