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

Model Number	AP-03000H
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the measured flow rate did not match the labeled arterial flow rate.The physician reported that flow rates were measured in several intera pumps following their implant procedures and alleged that the measured flow rates did not match the device's labeled arterial flow rates.The specific infusate was not reported.The devices remain implanted in the patients.Good faith efforts are being attempted for additional information regarding patient impact.
Additional Manufacturer Narrative
Date of event estimated using the date of when boston scientific first became aware of the complaint.Detailed product information was not provided to boston scientific.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: 50175264
• Report Number: 2124215-2026-42304
• Device Sequence Number: 8270956
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: (01)00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/07/2026
• 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 Sex: Unknown