BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11054500 · Received December 22, 2020

    Report

    Report Number
    9681834-2020-00260
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 26, 2020
    Report Date
    December 22, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN PRODUCT CODE, AND LOT NUMBER. UDI NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K926214. DEVICE MANUFACTURER DATE UNKNOWN DUE TO UNKNOWN PRODUCT CODE AND LOT NUMBER. TWO ACTUAL GUIDEWIRES (REFERRED TO AS SAMPLE-A AND SAMPLE-B IN THIS REPORT) AND FRAGMENTS (SAMPLE-C) CONTAINED IN A SYRINGE WERE RECEIVED FOR EVALUATION. INSPECTION OF SAMPLE-A: VISUAL INSPECTION CONFIRMED THE ABSENCE OF A BREAK IN THE SHAFT AND SEPARATION OF SURFACE MATERIAL. THE TOTAL LENGTH WAS 2200 MM. MAGNIFYING INSPECTION FOUND NO SCRATCHES ON THE SURFACE OR NO SEPARATION OF SURFACE MATERIAL. ELECTRON MICROSCOPIC INSPECTION OF THE SHAFT CONFIRMED THE PRESENCE OF CRACK PATTERN PECULIAR TO THE HYDROPHILIC COATING, WHICH INDICATED NO ANOMALY IN THE APPLICATION STATE OF THE HYDROPHILIC COATING (THE HYDROPHILIC COATING GETS SWOLLEN WHEN IT CONTAINS MOISTURE. IN THE DRY STATE, CRACK PATTERN APPEARS ON THE SURFACE. THE CRACK PATTERN HAS SOME INTER-INDIVIDUAL DEFERENCE BY PRODUCT). THE OUTER DIAMETER OF THE SHAFT WAS MEASURED AND CONFIRMED TO BE 0.84 MM, WHICH MET THE CONTROL CRITERIA OF THE 0.035" GUIDEWIRE. INSPECTION OF SAMPLE-B: VISUAL INSPECTION CONFIRMED THE ABSENCE OF A BREAK IN THE SHAFT OR SEPARATION OF SURFACE MATERIAL. THE TOTAL LENGTH WAS 1500 MM. MAGNIFYING INSPECTION FOUND NO SCRATCHES ON THE SURFACE OR NO SEPARATION OF SURFACE MATERIAL. ELECTRON MICROSCOPIC INSPECTION OF THE SHAFT CONFIRMED THE PRESENCE OF CRACK PATTERN PECULIAR TO THE HYDROPHILIC COATING, WHICH INDICATED NO ANOMALY IN THE APPLICATION STATE OF THE HYDROPHILIC COATING. THE OUTER DIAMETER OF THE SHAFT WAS MEASURED AND CONFIRMED TO BE 0.84 MM, WHICH MET THE CONTROL CRITERIA OF THE 0.035" GUIDEWIRE. INSPECTION OF SAMPLE-C: VISUAL AND MAGNIFYING INSPECTION REVEALED THAT BLACK FRAGMENTS AND BROWN FRAGMENTS HAD BEEN CONTAINED IN THE SYRINGE. THE BLACK AND BROWN FRAGMENTS WERE SUBJECTED TO COMPONENT ANALYSIS BY FT-IR. AS A RESULT, BOTH OF THEM WERE CONFIRMED TO BE DIFFERENT FROM THE SURFACE MATERIAL OF TERUMO CORPORATION MADE GUIDEWIRES. THE PRODUCTION CODE AND LOT NUMBER WERE NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. DURING THE INVESTIGATION, SEPARATION OF SURFACE MATERIAL OR PEELING OF HYDROPHILIC COATING WAS NOT OBSERVED IN SAMPLE-A OR SAMPLE-B. THE COMPONENT OF SAMPLE-C WAS CONFIRMED TO BE DIFFERENT FROM THAT OF THE SURFACE MATERIAL USED FOR TERUMO CORPORATION MADE GUIDEWIRES; HOWEVER, THE ORIGIN OF SAMPLE-C COULD NOT BE IDENTIFIED FROM THE AVAILABLE INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THIS REPORT IS FOR THE SECOND DEVICE REPORTED, FOR THE FIRST DEVICE SEE MDR 9681834-2020-00255. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. THE GUIDEWIRE WAS USED FOR COIL EMBOLIZATION IN THE INTERNAL ILIAC DURING PRETREATMENT FOR EVAR CASE. AFTER THE COIL EMBOLIZATION, WHEN THEY WERE GOING TO MOVE ON TO STENT GRAFT, MULTIPLE BLACK FRAGMENTS WERE FOUND FLOATING IN A PLASTIC VAT. THE GUIDEWIRE WAS REMOVED FOR SAFETY, AS THE SOURCE OF THE FRAGMENTS WAS UNKNOWN. THEY EXCHANGED THE GUIDEWIRE TO CONTINUE THE PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY. CURRENTLY THERE WAS NO HARM TO THE PATIENT'S HEALTH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520812 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1