MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT

Model Number	AP-07004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
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.The device arrived at intera oncology on (b)(6) 2025, and is under evaluation.Therefore, once the evaluation is completed a supplemental report will be submitted.
Event or Problem Description
Intera oncology was notified by a physician that on (b)(6) 2025, during or pump prep, the or prep kit had a leak between the needle and the tubing.The connection was very tight but there was still leakage.
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 returned needle and tubing was tested at intera oncology along with an r&d pump.The needle and tubing set arrived connected from the clinic.The needle was inserted into the pump septum and a 10ml syringe was attached to the tubing set.While attempting to fill the pump, a leak was observed between the needle and tubing set.The needle was removed from the pump and the connection between the needle and tubing set was tightened.The needle was re-inserted into the pump.The pump fill was re-attempted and no further leakage was observed.The reported failure could not be repeated after the connection between the needle and tubing was set was tightened.
Event or Problem Description
Intera oncology was notified by a physician that on (b)(6) 2025, during or pump prep, the or prep kit had a leak between the needle and the tubing.The connection was very tight but there was still leakage.

• Brand Name: INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT
• Common Device Name: OR PREP KIT
• 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: 24056760
• Report Number: 3015537318-2026-00002
• Device Sequence Number: 21337966
• Product Code: PTI
• UDI-Device Identifier: 00850014110154
• UDI-Public: 00850014110154
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 10/05/2026
• Device Model Number: AP-07004
• Device Catalogue Number: AP07004
• Device Lot Number: 24K050CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2024
• 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
• Patient Sex: Unknown