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

Model Number	44035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Chest Pain (1776)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2023, plaintiff underwent placement of an angiodynamics xcela product, reference number h965440350, lot number 5767870.The device was implanted by (b)(6) md, at (b)(6), for chemotherapy administration.On or about july 23, 2023, plaintiff presented to (b)(6) with chest pains and was admitted after blood cultures showed gram positive cocci and streptococcus agalactiae.His physicians determined the source of the infection was the xcela port and required removal.On or about(b)(6) 2023 plaintiff's infected port was removed by dr.(b)(6) md at (b)(6).As a result of having the xcela implanted, plaintiff has, allegedly, experienced significant pain and suffering, has undergone additional surgeries, and has suffered financial or economic loss, including, but to limited to, obligations for medical services and expenses.
Additional Manufacturer Narrative
The reported 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 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.The 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 packaging lot were reviewed; with no issues observed.Labeling review: the direction for use (dfu) provided with the xcela plus 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 or usage of the port, the system should be flushed to clear infusates and/or blood components in order to maintain patency.Refer to the "use and maintenance" section of this dfu for recommendations.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 potential complications: bacteremia, catheter thrombosis, inflammation, infection, implantation site necrosis or infection, thromboembolism, thrombophlebitis, tunnel infection.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.Perform hand hygiene before and after all vascular access procedures.Prepare skin with antiseptic solution per institutional protocol.Aseptically locate and access port including use of sterile gloves and mask per the non-coring needle dfu.Add dressing and stabilization per institutional protocol.Assess the access site, port functionality, change dressing and replace non-coring needle per institutional protocols.After therapy completion, flush and lock port per institutional protocol.Close the extension tubing clamp while injecting the last 0.5 ml of lock solution.When therapy is complete, remove the non-coring needle per product dfu and cover site according to institutional protocol.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: 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: 20493597
• Report Number: 1317056-2024-00195
• Device Sequence Number: 17024072
• Product Code: LJT
• UDI-Device Identifier: H965440350
• UDI-Public: H965440350
• 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: 2023
• Device Explanted 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): 11/26/2024

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: 11/30/2025
• Device Model Number: 44035
• Device Lot Number: 5767870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Male