MAUDE Adverse Event Report: INTERA ONCOLOGY, INC Intera 3000; Hepatic Artery Infusion Pump

Model Number	AP-03000H
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Hepatic or Biliary Problem (4493)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Intera oncology was notified that an intera 3000 hepatic artery infusion pump was flowing glycerin slower-than-expected during routine follow-up.Documented glycerin refill/calculated flow rates were as follows: 0.22 ml/day on (b)(6) 2025 (18 ml residual, 56 days); 0.21 ml/day on (b)(6) 2025 (18 ml residual, 56 days); 0.16 ml/day on (b)(6) 2026 (21 ml residual, 61 days); 0.18 ml/day on (b)(6) 2026 (20 ml residual, 56 days); and 0.186 ml/day on (b)(6) 2026 (24 ml residual, 35 days).The reported glycerin flow remained steady without interruption.The pump was explanted on (b)(6) 2026, primarily due to progression of disease and not solely due to the observed glycerin flow rate.
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.On (b)(6) 2026, a return kit was shipped to retrieve the pump for evaluation.Therefore, once we receive the pump and is evaluated, a supplemental report will be submitted.
Event or Problem Description
Intera oncology was notified that an intera 3000 hepatic artery infusion pump was flowing glycerin slower-than-expected during routine follow-up.Documented glycerin refill/calculated flow rates were as follows: 0.22 ml/day on (b)(6) 2025 (18 ml residual, 56 days); 0.21 ml/day on (b)(6) 2025 (18 ml residual, 56 days); 0.16 ml/day on (b)(6) 2026 (21 ml residual, 61 days); 0.18 ml/day on (b)(6) 2026 (20 ml residual, 56 days); and 0.186 ml/day on (b)(6) 2026 (24 ml residual, 35 days).The reported glycerin flow remained steady without interruption.The pump was explanted on (b)(6) 2026, primarily due to progression of disease and not solely due to the observed glycerin flow rate.
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.The device was investigated and all investigative testing that was performed passed, and the failure of slow flow could not be repeated.Therefore, the complaint could not be confirmed.

• 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: 25678483
• Report Number: 3015537318-2026-00069
• Device Sequence Number: 4644302
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 29697756
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Unknown