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 Code	Thrombosis/Thrombus (4440)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Intera oncology was notified by a physician that thrombosis clogged the catheter.The doctor used robotic surgery to reopen and reinsert the catheter inside the abdomen.The pump was explanted and new pump was implanted on the same day.The patient continues to receive hepatic artery infusion (hai) therapy.
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.Thrombosis is a known adverse event that is listed on the intera 3000 label and instruction for use.

• 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: 25178718
• Report Number: 3015537318-2026-00049
• Device Sequence Number: 10434200
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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 Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 31683816
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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: Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 140 KG
• Patient Race: White