BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 9961704 · Received April 15, 2020

    Report

    Report Number
    9681834-2020-00060
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    December 5, 2019
    Report Date
    April 15, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K122590, K163004. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVAVTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVAVTAGE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. IT IS LIKELY THAT THE ACTUAL SAMPLE WAS STUCK IN THE CONCURRENTLY USED BALLOON CATHETER, AND IN THAT STATE, IT WAS EXPOSED TO PULLING FORCE IN THE WITHDRAWAL DIRECTION, WHICH RESULTED IN THE SEPARATION OF THE URETHANE COATING FROM THE CORE WIRE. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE ACTUAL RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE PROCEDURE. THEY TRIED TO PROBE A DORSALIS PEDIS WITH THE GWA 18 IN COMBINATION WITH 2/150 / 130CM PACIFIC PLUS. 2 CM LONG CLOSURE WITHOUT VISIBLE PLAQUE CONTENT. PROBING WAS NOT POSSIBLE, AND THEY CHANGED TO A GWA 14. AFTER REMOVING THE GWA 18, IT WAS NOTICED THAT A PIECE OF THE HYDROPHILIC COATING ON THE WIRE TIP WAS MISSING. THE TIP WAS NOT VISIBLE IN THE PATIENT. IT WAS NOT CLEAR WHERE THE COATING REMAINED. THERE WAS NO ACTUAL HARM TO THE PATIENT REPORTED. THERE IS A POSSIBLE LOOSE PIECE INSIDE OF THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 31MAR2020. THE STATEMENT: "A PIECE OF THE HYDROPHILIC COATING ON THE WIRE TIP IS MISSING" DOES MEAN THAT THE URETHANE COATING WAS SEPARATED OFF FROM THE CORE WIRE; SINCE A PIECE OF COATING WAS MISSING, IT MEANS THAT THE PIECE WAS SEPARATED. THE SEPARATION/EXFOLIATION OF "THE HYDROPHILIC COATING" OCCURRED AFTER REMOVAL FROM THE PATIENT'S BODY, THAT IS WHEN THE MISSING PIECE WAS NOTICED. THE HYDROPHILIC COATING SEPARATED/EXFOLIATED FROM THE REPORTED WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425523 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 190702

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other