BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 22855238 · Received August 20, 2025

    Report

    Report Number
    3015537318-2025-00074
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 23, 2025
    Report Date
    October 28, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    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. INTERA ONCOLOGY IS WAITING FOR THE CATHETER TO ARRIVE FOR EVALUATION. THEREFORE, ONCE WE EVALUATE THE CATHETER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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. THE PORTION OF THE CATHETER WAS RECEIVED AND EVALUATED. DURING EVALUATION, A HOLE IN THE CATHETER WAS CONFIRMED. DUE TO THE SHARP EDGES OF THE HOLE, IT IS POSSIBLE THAT THE HOLE WAS FORMED DURING SURGERY BY NICKING THE CATHETER WITH A SUTURE NEEDLE WHEN TYING THE PUMP INTO THE PUMP POCKET. HOWEVER, A DEFINITIVE CONCLUSION OF HOW THE HOLE WAS FORMED CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT DURING SURGERY HE WAS ABLE TO FLUSH THE BOLUS PATHWAY. BUT WHEN ATTEMPTING TO ACCESS THE PUMP FOR THE HAPS SCAN HE WAS UNABLE TO FLUSH. ACCORDING TO THE PHYSICIAN, THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS NOT EXPLANTED. WHEN THE PHYSICIAN ACCESSED THE PUMP AND DID AN ARTERIOGRAM IT WAS DISCOVERED THERE WAS A HOLE IN THE CATHETER WHERE IT EXITED FROM THE PUMP. THE PHYSICIAN USED A BARBED CONNECTOR TO SPLICE TOGETHER THE CATHETER AFTER REMOVING THE DEFECTIVE PIECE. THE PATIENT'S THERAPY WAS NOT DELAYED, BUT THE PATIENT NEEDED TO HAVE ANOTHER SURGERY TO CORRECT THE PROBLEM.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT ON (B)(6) 2025, HE WAS UNABLE TO ACCESS THE INTERA 3000 HAI PUMP TWICE FOR HAPS STUDY. THE PUMP WAS REFILLED TO AVOID BEING DRY AND THE CLINIC SCHEDULED A FOLLOW-UP APPOINTMENT TO POTENTIALLY EXPLANT THE PUMP. IN THE FOLLOWING APPOINTMENT, THE PHYSICIAN WAS ABLE TO ACCESS THE PUMP. AN ARTERIOGRAM WAS DONE AND SHOWED A LEAK COMING FROM THE CATHETER ALONG WITH REVEALING A HOLE IN THE CATHETER. THE PHYSICIAN DID NOT EXPLANT THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP NOR REMOVED THE CATHETER. THE PHYSICIAN ONLY CUT THE PIECE OF THE CATHETER THAT HAD THE HOLE AND USED A BARBED CONNECTOR TO CONNECT TO THE CATHETER. THE PORTION OF THE CATHETER THAT HAD THE HOLE WAS RETURNED TO INTERA ONCOLOGY FOR EVALUATION. THE PUMP REMAINS IMPLANTED, AND THE PATIENT CONTINUES WITH HAI THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408710 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30139907 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female