BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 9378471 · Received November 26, 2019

    Report

    Report Number
    1118880-2019-00338
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 26, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K954234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO THE UPDATE TO THE H3 SECTION AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 9FR INTRODUCER SHEATH AND THE DILATOR WERE RECEIVED FOR PRODUCT EVALUATION. VISUAL INSPECTION REVEALED THAT THE VALVE WAS NESTED IN THE SHEATH HUB WHERE THE TOP AND BOTTOM OF THE VALVE ARE ORIENTED PARALLEL TO THE SHEATH HUB. DAMAGE WAS OBSERVED ON THE TIP OF THE SHEATH AND WAS CONFIRMED UNDER MICROSCOPE. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE CROSSCUT VALVE WAS NOT IN THE CORRECT ORIENTATION WHICH LIKELY RESULTED IN THE REPORTED EVENT. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO IS FURTHER INVESTIGATING THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE HOSPITAL WAS PERFORMING A TRANS-JUGULAR LIVER BIOPSY WITH A IK DEVICE. WIRE ACCESS TO THE JUGULAR VEIN WAS ACHIEVED AND THE 9FR X 10CM SHEATH WAS INSERTED OVER THE WIRE. BLOOD BEGAN BRISKLY POURING FROM THE VALVE AFTER THE DILATOR WAS REMOVED. THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER IK DEVICE. THE PATIENT PRESSURE WAS A BIT LOW BUT DID NOT REQUIRE TRANSFUSION (JUST ADDED VOLUME OF FLUIDS). ESTIMATED BLOOD LOSS WAS ABOUT 200CC BUT HARD TO TELL WHEN IT WAS ON THE FLOOR AND DRAPE. THE CASE FINISHED SUCCESSFULLY ONCE THE SHEATH WAS EXCHANGED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170507 RADIFOCUS INTRODUCER II KIT INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1