BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 9353645 · Received November 21, 2019

    Report

    Report Number
    1118880-2019-00324
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 21, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701007502
    PMA / PMN Number
    K954234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP TO UPDATE AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 9FR INTRODUCER SHEATH, DILATOR, AND CROSSCUT VALVE WERE RECEIVED FOR PRODUCT EVALUATION. VISUAL INSPECTION REVEALED THAT THE CROSSCUT VALVE WAS MISSING FROM THE SHEATH HUB. THE VALVE WAS RETURNED BUT WAS NOT INSIDE OF THE SHEATH HUB. THE VALVE WAS VIEWED UNDER MICROSCOPE AND NO DAMAGE WAS SEEN AT THE CENTER OF THE CROSSCUT VALVE. THE DILATOR DID NOT HAVE ANY DAMAGE, GROSS ANOMALIES, OR OCCLUSIONS. 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 DILATOR WAS INSERTED OFF-CENTER INTO THE VALVE, DISLODGING THE VALVE FROM ITS INTENDED ORIENTATION. 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

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY INSERTED A IK DEVICE SHEATH AND DILATOR. AS THEY REMOVED THE DILATOR FROM THE SHEATH, THEY LOOKED DOWN AND THE ENTIRE ROUND RUBBER VALVE CAME OUT WITH THE DILATOR. THEY APPLIED PRESSURE AND INSERTED ANOTHER SHEATH. PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED 29OCTOBER2019: ELECTROPHYSIOLOGY PROCEDURE WAS PERFORMED. WHILE THE DILATOR WAS BEING REMOVED, THE CLEAR RUBBER VALVE CAME OUT WITH THE DILATOR. THE DOCTOR DID NOT LOSE WIRE ACCESS. THEY USED ANOTHER A IK DEVICE AND SUCCESSFULLY FINISHED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151476 RADIFOCUS INTRODUCER II KIT INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A XE03 00389701007502

    Patients

    Seq Age Sex Outcome Treatment
    1