MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT

Model Number	AP-07004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution.There was one manufacturing deviation.However, the lone deviation did not contribute to the reported event.On september 5, 2025, intera oncology shipped a return kit to the physician office to retrieve the actual device for examination.To date, the device has not been returned.Therefore, once we receive the device and it's evaluated, a supplemental report will be submitted.
Event or Problem Description
Intera oncology received a report from a physician that during pump preparation, the pump was filled with 5ml's, the scrub tech noticed a leak between the needle and tubing.An intera oncology representative instructed the physician to clamp the center of the tubing, but the leak continued, likely from the 5ml's in the pump pushing back.Our representative instructed the physician to pull the needle out of the pump and tighten the connection as hard as she could with her hands.She did then insert the needle back in the pump, the leak continued.Our representative then instructed the physician to pull the needle from the pump and use some hemostats to fully secure the connection.After this there was no more leaking at the connection.
Event or Problem Description
Intera oncology received a report from a physician that during pump preparation, the pump was filled with 5ml's, the scrub tech noticed a leak between the needle and tubing.An intera oncology representative instructed the physician to clamp the center of the tubing, but the leak continued, likely from the 5ml's in the pump pushing back.Our representative instructed the physician to pull the needle out of the pump and tighten the connection as hard as she could with her hands.She did then insert the needle back in the pump, the leak continued.Our representative then instructed the physician to pull the needle from the pump and use some hemostats to fully secure the connection.After this there was no more leaking at the connection.
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution.There was one manufacturing deviation.However, the lone deviation did not contribute to the reported event.The tubing was returned to intera oncology headquarter for investigation.The complaint investigator connected the tubing to an r&d refill needle in lab and filled an r&d pump with 30ml of water.The operator then emptied the pump.This was repeated twice and there was no leakage observed.The failure could not be repeated.

• Brand Name: INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR PREP KIT
• Common Device Name: OR PREP KIT
• 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: 23043343
• Report Number: 3015537318-2025-00087
• Device Sequence Number: 9477266
• Product Code: PTI
• UDI-Device Identifier: 00850014110154
• UDI-Public: 00850014110154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K211121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 07/31/2026
• Device Model Number: AP-07004
• Device Catalogue Number: AP07004
• Device Lot Number: 24G303CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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