BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10156894 · Received June 16, 2020

    Report

    Report Number
    9681834-2020-00100
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 16, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K926214. THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED BY THE USER FACILITY. THEREFORE, THE INVESTIGATION WAS BASED ON USER FACILITY INFORMATION, THE PROVIDED PHOTOGRAPH AND EVALUATION OF THE RETENTION SAMPLE. REVIEW OF THE PICTURE CONFIRMED THAT THE URETHANE COATING OF THE ACTUAL SAMPLE HAD BEEN SEPARATED PARTIALLY FROM THE CORE WIRE. REPRODUCTIVE TESTING WAS PERFORMED ON A GUIDEWIRE SAMPLE. IT WAS INSERTED INTO A METAL NEEDLE INCLUDED IN AN IVH KIT, AND THEN WITHDRAWN FROM IT IN THE MANNER OF THE GUIDEWIRE SAMPLE HAVING CONTACT WITH THE EDGE OF THE METAL NEEDLE. THE URETHANE COATING WAS SHEARED OFF FROM THE GUIDEWIRE SAMPLE. MAGNIFYING INSPECTION OF THE SHEARED SECTION OF THE URETHANE COATING FOUND THAT ITS SURFACE WAS IN THE SMOOTH STATE AS IF IT HAD BEEN CUT WITH A CUTTING TOOL. THE CORE WIRE WAS FOUND EXPOSED. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE ADVANTAGE 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. IT IS LIKELY THAT THE SAMPLE MIGHT HAVE BEEN WITHDRAWN THROUGH THE CONCURRENTLY USED METAL NEEDLE IN THE MANNER OF COMING INTO CONTACT WITH THE EDGE OF THE NEEDLE, RESULTING IN SHEARING OF THE URETHANE COATING. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. IVH CATHETER PLACEMENT IN THE PATIENT'S SUBCLAVIAN VEIN. PUNCTURE WAS DONE WITH A METAL NEEDLE INCLUDED IN A KIT. NEXT, A GUIDE WIRE OF THE KIT WAS INSERTED THROUGH THE METAL NEEDLE, BUT IT DID NOT GO INTO THE VESSEL. THEY STOPPED USING IT AND INSERTED THE ACTUAL SAMPLE INTO THE METAL NEEDLE; HOWEVER, IT DID NOT GO INTO THE VESSEL. WHEN THEY PULLED OUT THE ACTUAL SAMPLE, IT CAME INTO CONTACT WITH THE METAL NEEDLE RESULTING IN PEELED-OFF URETHANE COATING. THE PEELED OFF URETHANE PIECE WAS RETRIEVED AS IT WAS AND DID NOT REMAIN IN THE PATIENT BODY. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621240 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 191205

    Patients

    Seq Age Sex Outcome Treatment
    1