BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 24965689 · Received April 23, 2026

    Report

    Report Number
    3015537318-2026-00033
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 22, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THROMBOSIS AND HEMATOMA ARE KNOWN ADVERSE EVENTS LISTED IN THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP IFU AND LABEL.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT REPORT FROM A PHYSICIAN, IN WHICH THEY NOTED THE PATIENT COMPLETED 4 CYCLES OF FLOXURIDINE AND WAS TOLERATING WELL. HOWEVER, CYCLE 5 WAS HELD DUE TO 3 TIMES INCREASE IN ALKALINE PHOSPHATASE. SURVEILLANCE IMAGING WAS COMPLETED AND CT ABDOMEN DEMONSTRATED ACUTE COMPLETE THROMBOSIS OF THE TRANSVERSE/HORIZONTAL DIVISION OF LEFT PORTAL VEIN; RETRACTED TIP OF THE CATHETER; AND A LOW ATTENUATION SURROUNDING THE CATHETER TIP. CT ANGIOGRAPHY (CTA) ABDOMEN NOTED A LIKELY PSEUDOANEURYSM SECONDARY TO THE RETRACTED CATHETER TIP. PATIENT WAS HEMODYNAMICALLY STABLE AND ASYMPTOMATIC. ACCORDING TO THE PHYSICIAN, NO INTERVENTION WAS NEEDED AND CONSULTED WITH ANOTHER PHYSICIAN FROM MEMORIAL SLOAN KETTERING CANCER CENTER (MSK), WHO THOUGHT THERE WAS MORE LIKELY A HEMATOMA AROUND THE ARTERY RATHER THAN A PSEUDOANEURYSM. THE CLINIC PLANNED A SHORT INTERVAL IMAGING FOLLOW UP. ON APRIL 1, 2026, INTERA ONCOLOGY WAS INFORMED THAT THE RECENT FINDINGS ON CT ARE MORE POSTOP CHANGES AND RELATED TO HEMATOMA NOT PSEUDOANEURYSM, THIS WAS CONFIRMED BY 2 SURGEONS FROM MSK. THE PHYSICIANS WILL CONTINUE TO MONITOR THE PATIENT AND WILL REPEAT IMAGING IN 4 TO 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456228 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 31301180 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention