MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 3000; HEPATIC ARTERY INFUSION PUMP

Model Number	AP-03000H
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	04/28/2026
Type of Reportable Event	Serious Injury
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, the contamination was likely related to inadvertent bowel nicking during the surgical procedure, resulting in non-sterile contamination of the initial pump.In addition, there was not any concern regarding pump functionality or product sterility.Therefore, the root cause is traced to surgical use error.
Event or Problem Description
The patient underwent pump insertion procedure.During insertion, the pump became contaminated secondary to bowel exposure and was immediately removed from the sterile field.Following discussion with boston scientific specialists present in the operating room during pump replacement, it was disclosed that the physician's resident was performing the procedure.The physician requested a replacement pump due to contamination encountered during surgery.Although full visual confirmation was not obtained by the boston scientific specialist, the contamination was likely related to inadvertent bowel nicking during the surgical procedure, resulting in non-sterile contamination of the initial pump.The request for replacement was not related to any concern regarding pump functionality or product sterility upon opening, but rather to intraoperative events occurring during the surgical procedure.

• 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: 25255980
• Report Number: 3015537318-2026-00056
• Device Sequence Number: 14806990
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/19/2026

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: 32404056
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2025
• 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: Required Intervention
• Patient Sex: Unknown