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

Model Number	AP-07004
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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.When the actual or prep kit arrived at intera oncology headquarters, it was confirmed that a small black looking bug/fly was in the peel pack.Intera oncology has communicated with the contract manufacturer to investigate the issue.As of today, the investigation is ongoing.Therefore, once the investigation concludes, a supplemental report will be submitted.
Event or Problem Description
The circulator started to serve or prep kit to sterile field.When the circulator opened the corner of the peel pack with syringe and tubing, a small black looking bug/fly was observed in the peel pack.The circulator immediately closed the peel pack, put it back in the or prep box and pulled a new or prep kit from another pump box.
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.As previously mentioned, when the actual or prep kit arrived at intera oncology headquarters, it was confirmed that a small black looking bug/fly was in the peel pack.Intera oncology communicated with the contract manufacturer to investigate the issue.The contract manufacturer confirmed the reported issue and retrained their operators.Therefore, the root cause is traced to manufacturing.
Event or Problem Description
The circulator started to serve or prep kit to sterile field.When the circulator opened the corner of the peel pack with syringe and tubing, a small black looking bug/fly was observed in the peel pack.The circulator immediately closed the peel pack, put it back in the or prep box and pulled a new or prep kit from another pump box.

• 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: 23587651
• Report Number: 3015537318-2025-00107
• Device Sequence Number: 9304723
• Product Code: PTI
• UDI-Device Identifier: 00850014110130
• UDI-Public: 00850014110130
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 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: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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