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

Model Number	AP-03000H
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump was flowing faster than intended.The patient had the intera 3000 hepatic artery infusion (hai) pump implanted in (b)(6) 2026.The pump was first filled with floxuridine on july 29, 2026, and the patient had no complications.On (b)(6) 2026, the patient contacted boston scientific and reported that the pump was running fast, at an average of 1.7 ml/day instead of 1.2 ml/day.The patient reported that her care team was aware, but was unable to resolve the issue via troubleshooting.Follow-up contact was attempted by telephone and email to obtain additional information; no further information was received at the time of this report.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, 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): Boston Scientific Corporation; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50674820
• Report Number: 2124215-2026-47921
• Device Sequence Number: 5253390
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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 Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/08/2026
• 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
• Patient Age: 46 YR
• Patient Sex: Unknown