BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 16041075 · Received December 23, 2022

    Report

    Report Number
    9681834-2022-00253
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    October 20, 2022
    Report Date
    December 23, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. 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): K063372, K122590, K163004. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ON (B)(6) 2022, THE ACTUAL NAVICROSS SAMPLE WAS DISSEMBLED DURING INVESTIGATION FOR (B)(4), AND THEN A PIECE OF COATING OF THE GUIDEWIRE ADVANTAGE THAT WAS USED IN COMBINATION WITH THE NAVICROSS WAS FOUND IN THE LUMEN. THEREFORE, (B)(4) WAS ISSUED. THE INVESTIGATION OF THIS PPR WAS LIMITED AS FOLLOWS AS THE MAIN BODY WAS NOT AVAILABLE. SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE REVIEWED. SINCE THE LOT NUMBER WAS UNKNOWN, SIMILAR EVENTS COULD NOT BE SEARCHED. IN THE RECORD OF THE PAST THREE YEARS (B)(6) 2019 TO (B)(6) 2022) FOR THE INVOLVED PRODUCT CODE, NO DEVIATION OR NO NON-CONFORMITIES ASSOCIATED WITH PEELING OF COATING WAS OBSERVED. ACCORDING TO THE INVESTIGATION RESULTS, THERE WERE NO DEVIATIONS OR NO NON-CONFORMITIES RELATED TO THE PEELING OF COATING IN THE PAST THREE (3) YEARS REGARDING THE INVOLVED PRODUCT CODE. AS ONE OF THE POSSIBILITIES IN THIS CASE, WHEN BOTH DEVICES WERE USED IN COMBINATION, IT WAS THOUGHT THAT AN ABRASION LOAD WAS APPLIED WHEN THE OUTER SURFACE OF THE ACTUAL SAMPLE AND THE INNER SURFACE OF THE NAVICROSS WERE IN STRONG CONTACT FOR SOME REASON, WHICH RESULTED IN THE PEELING OF COATING. HOWEVER, SINCE THE GUIDEWIRE MAIN BODY WAS NOT RETURNED, THE CAUSE OF THE OCCURRENCE COULD NOT BE CLEARLY DETERMINED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE 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. DO NOT ATTEMPT TO USE THE GLIDEWIRE ADVANTAGE IF IT HAS BEEN BENT, KINKED, OR DAMAGED. USE OF A DAMAGED WIRE MAY RESULT IN DAMAGE TO THE VESSEL OR THE RELEASE OF WIRE FRAGMENTS INTO THE VESSEL. 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 · 0

    THE USER FACILITY REPORTED GUIDEWIRE COATING, PEELED OFF THE INVOLVED GLIDE WIRE ADVANTAGE WIRE WAS NOT GOING THROUGH THE NAVICROSS CATHETER. THE GLIDEWIRE ADVANTAGE USED IN THAT PROCEDURE WAS REF (ITEM CODE) NUMBER : RA*FA18301CM. A PIECE OF COATING WAS FOUND IN THE LUMEN OF THE ACTUAL SAMPLE FOR (B)(4). IT APPEARED TO BE THE OUTER LAYER OF ADVANTAGE THAT WAS USED IN COMBINATION WITH THE ACTUAL SAMPLE. FROM THIS, IT IS INFERRED THAT THE OUTER LAYER OF THE CONCURRENTLY USED ADVANTAGE HAS PEELED OFF. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENTS FINAL IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110163 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NAVICROSS.