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	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution.One manufacturing deviation was opened to use a different procedure to manufacture the 35ml syringes in the or prep kits.The returned device was investigated, and the alleged failure could not be replicated.Therefore, the root cause remains inconclusive.
Event or Problem Description
Intera oncology received a complaint from a scrub technician that they were emptying the pump during the pump prep procedure and the connection at the non-coring needle and tubing leaked.The scrub technician hand tightened the needle and finished emptying the pump.The scrub technician attached the high dose heparin/saline, and it still leaked.She tightened the needle again using an instrument and the leak diminished to just a small drop.

• 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: 22650114
• Report Number: 3015537318-2025-00066
• Device Sequence Number: 8798332
• Product Code: PTI
• UDI-Device Identifier: 00850014110130
• UDI-Public: 00850014110130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 08/06/2026
• Device Model Number: AP-07004
• Device Catalogue Number: AP07004
• Device Lot Number: 24H064CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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