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

Model Number	AP-03000H
Medical Device Problem Codes	Material Integrity Problem (2978); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was no flow to the pump, resulting in additional surgery.The patient was implanted with an intera 3000 hepatic artery infusion pump.During a pump refill procedure on an unknown date, all 30 ml of medication was returned, indicating no flow.Imaging revealed that the catheter was twisted around a suture within the pump pocket.The surgeon opened the pump pocket and unraveled the catheter.The catheter was flushed using a special bolus needle to confirm that it was not occluded, and the pump was re-sutured into the pocket.The troubleshooting resolved the observed catheter twisting.The patient was scheduled for a hepatic arterial perfusion scintigraphy (haps) scan in a few days and a pump refill the following week.
Additional Manufacturer Narrative
Section b3: date of event estimated using the date when boston scientific first became aware of the complaint.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): 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: 50933395
• Report Number: 2124215-2026-51686
• Device Sequence Number: 10749732
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP-03000H
• Device Catalogue Number: AP-03000H
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• 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