BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTAL

    MDR report key: 17841578 · Received September 29, 2023

    Report

    Report Number
    3013656790-2023-00007
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 25, 2023
    Report Date
    October 26, 2023
    Manufacturer
    PHENOX LIMITED
    Product Code
    DQX
    UDI-DI
    05391530910040
    PMA / PMN Number
    K191687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING DESCRIPTION WAS PROVIDE FROM THE HEALTHCARE PROFESSIONAL: "THEY STARTED TO USE THE PORTAL, AND BEFORE REACHED THE LESION, REALIZED THAT THE GUIDE WIRE PORTAL HAD BROKEN IN HALF. THEY DIDN'T PUSH OR DID ANY PRESSION AND FEEL ANY KINKING BECAUSE THE ANATOMY WASN'T COMPLEX. THEY TRIED TO PULL IT OUT WITH A SOLITAIRE, A SNARE AND IT DIDN'T WORK. THEY ENDED UP USING A DERIVO´S FLOW DIVERTER. THE PATIENT WAS HOSPITALISED FOR 1 DAY, AS USUAL." DURING THE PROCEDURE, ONE PORTAL GUIDEWIRE WAS USED AND, BEFORE THE DEVICE REACHED THE LESION, IT WAS NOTED THAT THE PORTAL WIRE HAD BROKEN IN HALF. A MICROCATHETER WAS ALSO USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS NOT PUSHED AND NO PRESSURE WAS ADDED. KINKING WAS NOT FELT AS PATIENT'S ANATOMY WAS NOT COMPLEX. AN ATTEMPT WAS MADE TO REMOVE THE DETACHED PORTION OF THE DEVICE USING A THROMBECTOMY RETRIEVER AND SNARE BUT THE ATTEMPT WAS NOT SUCCESSFUL. A FLOW DIVERTER DEVICE WAS THEN USED AND THE DETACHED PART OF THE PORTAL DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO PROLONGATION OF PATIENT HOSPITALIZATION AND NO FURTHER INJURY WAS REPORTED. THE ADDITIONAL INFORMATION WILL BE OBTAINED, AND INVESTIGATION PERFORMED TO DETERMINE IF SERIOUS INJURY CAN BE ATTRIBUTED TO PORTAL DEVICE AND/OR COMBINATION OF DEVICES USED DURING PROCEDURE AND/OR USER ERROR.

    Description of Event or Problem · 0

    AT A LATER DATE IT WAS CLARIFIED THAT: DURING THE SAME PROCEDURE, MICROSNARE AND SOLITAIRE WERE ATTEMPTED BUT WERE NOT SUCCESSFUL TO REMOVE THE FRACTURED DISTAL FRAGMENT OF THE GUIDEWIRE (± 12 CM). FLOW DIVERTER DEVICE (DERIVO) WAS THEN ALSO USED HOWEVER, PHYSICIAN WASN'T SUCCESSFUL AT REMOVING THE DETACHED PART OF PORTAL GUIDEWIRE. THE FRACTURED DISTAL PIECE WAS LEFT IN THE PATIENT AND FIXED IN POSITION IN THE ARTERY FOR ENDOTHELIALISATION PURPOSE. PATIENTS CONDITION WAS STABLE AFTER THE PROCEDURE. PROXIMAL FRAGMENT OF THE DEVICE WAS REMOVED AND RETURNED TO PHENOX LTD. FOR ANALYSIS. INVESTIGATION TO BE PERFORMED ON THE AFFECTED DEVICE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278428 PORTAL PORTAL STEERABLE HYDROPHILIC GUIDEWIRE DQX PHENOX LIMITED PORT-14-200-1 8453187 05391530910040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention