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	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intera oncology received a report that during pump preparation the tubing from the or prep kit was leaking near where it connected with the refill needle.Once the clinic noticed the leak, they replaced the tubing by opening a new or prep kit.The pump prepped fine afterwards.
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution.There was one manufacturing deviation.However, the lone deviation did not contribute to the reported event.The sample was discarded by the clinic and photo evidence was not available.Therefore, the root cause is unknown.

• 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 ; 9178054424
• MDR Report Key: 22841456
• Report Number: 3015537318-2025-00073
• Device Sequence Number: 9580608
• Product Code: PTI
• UDI-Device Identifier: 00850014110154
• UDI-Public: 00850014110154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: AP-07004
• Device Lot Number: 24K050CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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