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 Code	Pocket Erosion (2013)
Date of Event	07/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Prior to (b)(6) 2022, plaintiff (b)(6) was diagnosed with cancer.The treatment for plaintiff's cancer included chemotherapy.In order to administer the chemotherapy medications to plaintiff, her physicians had a port-a-catheter placed in her right upper chest.On or about (b)(6) 2022, plaintiff underwent placement of the following angiodynamics' port xcela plus, inventory item: port imp inf xcela plus, plas 8.0f 63cm, implant name: port xcela plus, 8fr-log242721, model/cat no.: 44-032, manufacturer: angiodynamics, for the purposes of plaintiff's chemotherapy.On or about (b)(6) 2022, the device at issue was implanted by dr.(b)(6) at (b)(6) for the purposes indicated above.The defendants, directly or through their agents, apparent agents, servants, or employees, designed, manufactured, markets, advertised, distributed, and sold the port xcela plus that was implanted in (b)(6).Upon information and belief, on (b)(6) 2022, plaintiff presented to (b)(6) medical center in (b)(6) where plaintiff was seen for blood in her chemotherapy port and was treated for ulcerations and redness at the port site with antibiotics.Upon information and belief, plaintiff had been treated previously for an infection at her port site with antibiotics.On or above (b)(6) 2022, plaintiff was also treated for a suspected infection at the port site with antibiotics.On or about (b)(6) 2025, plaintiff again presented to (b)(6) medical center for complaints that her port-a-cath was eroding out of her skin.Upon information and belief, plaintiff's port-a-cath at issue was removed due to the above, at (b)(6) medical center.
Additional Manufacturer Narrative
The customer's reported complaint description of patient infection (and subsequent port erosion through skin) 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 packaging lot and sterilization records could not be performed since there was no reported lot number.The port was implanted into the patient 6 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 6 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 and port erosion through skin 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, septicemia or peritonitis.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.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/adverse events bacteremia, catheter thrombosis, catheter or port erosion through skin/vessel, · inflammation, infection, · implantation site necrosis or infection, thromboembolism, thrombophlebitis, tunnel infection.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) for event date 7/25/2022, mdr 1317056-2025-00209, reference (b)(4) for event date 7/20/2025.

• 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: 22844854
• Report Number: 1317056-2025-00210
• Device Sequence Number: 21241348
• Product Code: LJT
• UDI-Device Identifier: 15051684018821
• UDI-Public: 15051684018821
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 08/19/2025

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: H965440320
• Device Catalogue Number: 44032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/19/2025
• 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; Required Intervention
• Patient Sex: Female