MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA; TAPERED VASCULAR CATHETER

Model Number	IP-37957
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.As previously mentioned, the physician stated that the pump was functioning properly prior to implantation.Therefore, the cause of this report is traced to patient's anatomy.
Event or Problem Description
Intera oncology received a report from a physician that the implant was aborted due to patient's anatomy being insufficient for tapered catheter.The physician reported that the pump was functioning properly prior to implantation.During communication with the physician, he mentioned that the patient did not experience any adverse reactions.He confirmed the pump was in the pump pocket and removed after determining that the patient's anatomy is insufficient to the tapered catheter.
Event or Problem Description
Intera oncology received a report from a physician that the implant was aborted due to patient's anatomy being insufficient for tapered catheter.The physician reported that the pump was functioning properly prior to implantation.During communication with the physician, he mentioned that the patient did not experience any adverse reactions.He confirmed the pump was in the pump pocket and removed after determining that the patient's anatomy is insufficient to the tapered catheter.
Additional Manufacturer Narrative
Rationale for correction: updating section d1 and d10.As previously mentioned, the physician stated that the pump was functioning properly prior to implantation.Therefore, the cause of this report is traced to patient's anatomy.

• Brand Name: INTERA
• Common Device Name: TAPERED VASCULAR CATHETER
• 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: 23381444
• Report Number: 3015537318-2025-00099
• Device Sequence Number: 17368919
• Product Code: LKK
• UDI-Device Identifier: 00850014110093
• UDI-Public: 00850014110093
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• 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): 11/20/2025

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 Expiration Date: 09/30/2026
• Device Model Number: IP-37957
• Device Catalogue Number: IP37957
• Device Lot Number: 19703
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERA 3000 HAI PUMP SERIAL NUMBER(B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Race: White