MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 3000; HEPATIC ARTERY INFUSION PUMP

Model Number	AP-03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a possible infection to the physician approximately five days prior to admission.The patient was advised to present to the local emergency room for evaluation and later transfer to a hospital, as the patient resides approximately four hours from the treating facility.The patient presented to the emergency room on (b)(6) 2026.Imaging was performed on (b)(6) 2026, and upon further review, it was determined that pump removal was the best course of action due to disease progression with tumor spread to the lung.The physician also reported that the pump was eroding through the skin, and with progression of the disease, this was the reason for removal.The pump was explanted on (b)(6) 2026.Infection was not confirmed.The explanted pump is being disposed of per hospital protocol.
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.As previously mentioned, the physician reported that the pump was eroding through the skin and, in conjunction with progression of disease, determined that explantation was the most appropriate course of action.The device was explanted.Based on the available information, no device malfunction has been confirmed.Erosion and infection are known adverse events listed in the intera 3000 hepatic artery infusion pump ifu and label.

• Brand Name: INTERA 3000
• Common Device Name: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer Contact: jesus matos ; 180 wells avenue; suite 300a; newton, MA 02459
• MDR Report Key: 25232970
• Report Number: 3015537318-2026-00054
• Device Sequence Number: 18687942
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 09/30/2026
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 30963569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown