BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 14163451 · Received April 20, 2022

    Report

    Report Number
    9681834-2022-00070
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 20, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K863138, K923607, K926214. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. (B)(4). THE PATIENT'S DEATH WAS NOT A RESULT IN CONSEQUENCE DUE TO THE ADVERSE EVENT THAT OCCURRED. THE ACTUAL SAMPLE WAS NOT RETURNED TO ASHITAKA FACTORY, THE INVESTIGATION OF IT WAS UNABLE TO BE PERFORMED. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE HISTORY INSPECTIONS COULD NOT BE PERFORMED. AS ADDITIONAL INFORMATION, WE WERE INFORMED THAT THE PRODUCT WAS USED IN COMBINATION WITH A METAL ENTRY NEEDLE. BASED ON OUR PAST KNOWLEDGE, WE HAVE EXPERIENCED DURING A SIMULATION TEST THAT THE OUTER LAYER MAY HAVE BEEN PEELED OFF WHEN THIS PRODUCT WAS USED IN COMBINATION WITH A METAL ENTRY NEEDLE. IT WAS INFERRED THAT THE OUTER LAYER OF ACTUAL PRODUCT WAS PEELED OFF WHEN IT WAS USED IN COMBINATION WITH A METAL ENTRY NEEDLE. HOWEVER, SINCE THE ACTUAL PRODUCT WAS NOT RETURNED AND INVESTIGATION COULD NOT BE PERFORMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT IFU REFERENCE: "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PRODUCT INVOLVED WAS USED FOR PTCD IN THE GASTROENTEROLOGY. THEY WANTED TO ACCESS THE BILE DUCT BUT ACCESSED THE CYST. THE GUIDEWIRE WAS RUPTURED AT THE INVOLVED SITE AND REMAINED IN THE CYST. IT WAS POSSIBLE THAT PART OF THE ACTUAL PRODUCT WAS LEFT IN THE PATIENT'S BODY. THE FINAL PATIENT IMPACT WAS DEATH (NOT CAUSED BY THE PRODUCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273005 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CREATE MEDIC US COMPATIBLE PUNCTURE NEEDLE.