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

Model Number	H965440320
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On or about (b)(6), 2020, plaintiff underwent placement of an angiodynamics xcela power injectable port catheter device, with model number h965440320, and lot number 5545434.The device was implanted by dr.(b)(6) at (b)(6) medical center, missouri for chemotherapy administration to treat plaintiff's cancer.On or about(b)(6) 2022, plaintiff presented to the radiology department at (b)(6) medical center, missouri with complaints of extreme pain, inability for the port to accept infusions, and an inability for the port to produce a blood return as required for his chemotherapy infusions.Studies were conducted and it was determined there was an occlusion and the formation of a fibrin sheath.On or about (b)(6) 2022, a procedure was performed on plaintiff's by dr.(b)(6) stripping away the fibrin sheath and addressing the occlusion at (b)(6) medical center, mossouri.
Additional Manufacturer Narrative
The customer's reported complaint description of patient experienced port system occlusion cannot be confirmed given the patient centric nature of this event.No port/catheter product was returned to angiodynamics for evaluation since there was no reported port device malfunction, just occlusion and formation of fibrin sheath.Port system occlusion (e.G fibrin sheath formation) is cautioned in the device directions for use (dfu) as potential complication for an implanted port system.A device history record (dhr) review of the indicated packaging/catheter lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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 · catheter occlusion, malposition, dislodgment, fragmentation, migration, disconnection or rupture · catheter occlusion or breakage caused by pinching between clavicle and first rib · fibrin sheath formation · 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.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 pr37265.

• Brand Name: XCELA
• 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: 25452047
• Report Number: 1319211-2026-00198
• Device Sequence Number: 18727072
• Product Code: LJT
• UDI-Device Identifier: 15051684018821
• UDI-Public: 15051684018821
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/09/2026

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: 09/30/2022
• Device Model Number: H965440320
• Device Catalogue Number: 44032
• Device Lot Number: 5546434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2019
• 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
• Patient Sex: Male