MAUDE Adverse Event Report: Intera Oncology INTERA; Pump, Infusion, Implanted, Programmable

Model Number	AP-03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient developed an infection at the pump pocket site, leading to device explant.On(b)(6) 2026, the patient was implanted with an intera 3000 hepatic artery infusion pump in the left abdomen.The patient had their pump refilled every two weeks.On (b)(6) 2026, the patient presented for follow-up due to redness at the pump pocket site, signaling infection.The infection was treated by performing a revision procedure on (b)(6) 2026, during which the original pump was explanted, a new pump was implanted, and the replacement device was positioned on the opposite side of the abdomen.It was the physicians opinion that the device and implantation procedure did not contribute to the reported infection.The physician speculated that the infection may have been associated with either the colorectal team's involvement during the combination surgical procedure or inadequate skin preparation with chloraprep prior to a refill procedure.No other adverse patient events or clinical consequences were reported.
Additional Manufacturer Narrative
We are unable to provide the unique identifier (udi) # for this product.All available product data has been included in this report.Boston scientific is conducting an investigation to identify further product details.If further product details are identified, a supplemental report will be submitted.

• Brand Name: INTERA
• Common Device Name: Pump, Infusion, Implanted, Programmable
• Manufacturer (Section D): Intera Oncology; 180 wells avenue, ste 300a; newton MA 02459
• Manufacturer (Section G): MEDICAL DEVICE INTERMEDIATE INC; 110 forbes blvd; mansfield MA 02048
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50304657
• Report Number: 2124215-2026-44332
• Device Sequence Number: 10048428
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 0000021385
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 03/11/2026
• 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