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); No Flow (2991); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
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.Device migration is a known adverse event listed on the labeling of the intera 3000 pump and instructions for use.However, we are waiting for the pump explant to be complete and return for evaluation.Therefore, once the pump is evaluated, a supplemental report will be submitted.
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 when potentially glycerin was being administered.The review indicated slow flow associated with a catheter kink, present since at least october 2025.The patient had history with the pump flipping, which required manual repositioning and later surgical revision.It is unclear how many episodes of pump flipping may have occurred after the surgical revision.At subsequent follow-up, no flow was observed, and imaging confirmed a kinked catheter.The patient is reported to have progressive disease, and pump explant is scheduled for on (b)(6) 2026.

• 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: 25118122
• Report Number: 3015537318-2026-00046
• Device Sequence Number: 9326149
• 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: 2023
• 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): 09/14/2026

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: 12/31/2023
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 29066
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 220 LB
• Patient Race: White