BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 25032301 · Received April 29, 2026

    Report

    Report Number
    3015537318-2026-00037
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 REVIEWED ALL THE INFORMATION OBTAINED FROM THE PHYSICIAN AND DETERMINED THAT ROOT CAUSE OF THE REPORTED COMPLAINT IS DUE TO USE ERROR AS DURING DEVICE IMPLANTATION THE PHYSICIAN NOTED THAT THE PUMP PULLED BACK WHILE SUTURING THE CATHETER, CREATING A SHARP ANGLE AND OCCLUDING THE FLOW IN THE CATHETER.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED THAT DURING A HAPS STUDY, FLUSHING OF THE PUMP WITH SPECIAL BOLUS NEEDLE (SBN) WAS DIFFICULT TO INJECT. THE SURGEON WAS CALLED TO ASSESS THE SITUATION. LATER ON, (B)(6) 2026, IT WAS DECIDED THAT THE PATIENT WOULD RETURN TO THE OR FOR AN HAI PUMP PLACEMENT EXPLORATION. ON (B)(6) 2026, THE PATIENT WAS BROUGHT INTO THE OR. THE SURGEON OPENED THE PUMP POCKET, INSERTED AN SBN, AND ATTEMPTED TO ADMINISTER LOW-DOSE SALINIZED HEPARIN. HOWEVER, RESISTANCE WAS SIGNIFICANT. THE SURGEON THEN NOTED THAT THE CATHETER, AT THE POINT WHERE IT EXITS THE PUMP, WAS SHARPLY ANGLED DOWNWARD APPROXIMATELY 90 DEGREES, CREATING A KINK/SHARP BEND THAT PREVENTED FLOW. AS THE DOCTOR REMOVED THE PUMP FROM THE POCKET, A VISIBLE "RELEASE" OF THE CATHETER FROM THE SIDE OF THE PUMP WAS OBSERVED. A SBN WAS REINSERTED, AND THE DOCTOR INJECTED AGAIN, THIS TIME THE FLOW WAS UNOBSTRUCTED. IT WAS DETERMINED THAT WHEN THE PUMP WAS PLACED IN THE POCKET ON (B)(6) 2026, IT HAD "PULLED BACK" DURING TIGHTENING OF THE FINAL (FOURTH) SUTURE. THIS CAUSED SLIGHT TWISTING OF THE PUMP AND PULLED THE CATHETER TIGHTLY AGAINST IT, CREATING A SHARP ANGLE AND OCCLUDING FLOW. THE SAME PUMP WAS REPOSITIONED BACK INTO THE POCKET; THE PATIENT WAS CLOSED AND RETURNED TO THEIR ROOM. HAPS AND DISCHARGE WERE EXPECTED ON (B)(6) 2026. THE PHYSICIAN WAS SATISFIED WITH THE OUTCOME. DURING COMMUNICATION WITH THE SURGEON ON (B)(6) 2026, THE SURGEON CONFIRMED THAT THE CATHETER SILICON SLEEVE WAS NOT FLUSH WITH THE CATHETER, AND THE CATHETER WAS KINKED ON THE PROXIMAL/PUMP SIDE OF THE SLEEVE, UNDERNEATH ONE OF THE ANCHORING STITCHES. ONCE THE STITCH WAS RELEASED, THE PHYSICIAN WAS ABLE TO SLIDE THE SILICON SLEEVE BACK INTO THE PUMP AND STRAIGHTEN OUT THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16708 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 31597335 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female