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

Model Number	AP-03000H
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Intera oncology received a report of a patient that was identified during follow-up with the clinical team about the intera 3000 hepatic artery infusion pump having slow flow rates under glycerin treatments.The clinic provided us with the history of each of the refill flow rates since on (b)(6) 2025: on (b)(6) 2025: 0.23 ml/day, on (b)(6) 2025: 0.23 ml/day, on (b)(6) 2026: 0.14 ml/day, on (b)(6) 2026: 0.11 ml/day.The patient is planned for short-interval follow-up in 2 to 4 weeks for reassessment of flow rate, with consideration of a bolus pathway flush to further assess catheter patency.On (b)(6) 2026, the patient told the clinic they did not want additional medical testing/evaluation, and they confirmed they understood the risks and benefits that were explained to them.The patient is currently without evidence of disease (ned).Glycerin is being used to maintain catheter patency should salvage therapy be required in the future.
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.Intera oncology is in communication with the clinic and is waiting for additional information.Therefore, once we obtain updated information a supplemental report will be submitted.

• 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: 25115901
• Report Number: 3015537318-2026-00045
• Device Sequence Number: 10232094
• 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
• 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): 06/19/2026

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: 09/30/2025
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 29455848
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2026
• 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
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White