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

Model Number	AP-03000H
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hematoma (1884)
Date of Event	06/02/2026
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.Based on the information provided by the reporting physician, the reported event was not related to a device malfunction or performance issue.The implanted pump was reported to be functioning as intended at the time of explant.The pump exchange was performed due to contamination resulting from persistent wound dehiscence and exposure of the device secondary to wound healing complications.The physician indicated that the incision failed to heal and that device removal was necessitated by exposure of the pump, not by any deficiency in device function.Therefore, intera oncology's evaluation concludes that the reported event was attributable to the patient's clinical condition and surgical site complications rather than a malfunction of the pump.
Event or Problem Description
Intera oncology was notified on (b)(6) 2026, of a pump exchange procedure.The originally implanted pump (serial no.(b)(6)), implanted on (b)(6) 2026, was associated with persistent wound dehiscence and hematoma, resulting in exposure and contamination of the device.The physician reported that the pump was functioning as intended with no performance issues.During surgical exploration, contamination of the implanted pump was confirmed.The contaminated pump (serial no.(b)(6)) was explanted and replaced with a new pump (serial no.(b)(6)).According to the physician, the pump exchange was performed due to contamination associated with failure of the incision site to heal.The physician reported that the event was not related to pump performance or malfunction and stated that the device was removed because it had become exposed secondary to wound healing complications.

• 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: 25679635
• Report Number: 3015537318-2026-00061
• Device Sequence Number: 9709755
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/20/2026

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: 31486790
• 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: 06/04/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 144 KG