BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 14074811 · Received April 11, 2022

    Report

    Report Number
    9681834-2022-00059
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 11, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    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): K926214. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND THAT THE WIRE HAD BEEN EXPOSED AND THE OUTER LAYER HAD BEEN SCRATCHED AT APPROXIMATELY 40MM - 75MM FROM THE DISTAL END. THE EXPOSURE OF WIRE AND THE SCRATCH ON THE OUTER LAYER WERE AS FOLLOWS: (I) EXPOSURE OF THE WIRE: IT WAS OBSERVED OVER APPROXIMATELY 8MM. (II) SCRATCH ON THE OUTER LAYER: IT WAS OBSERVED OVER APPROXIMATELY 25MM. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS: (I) THE PEELED OUTER LAYER HAD A STEEP SLOPE ON THE DISTAL SIDE AT APPROXIMATELY 40MM FROM THE DISTAL END, WHILE IT HAD A GENTLE SLOPE ON THE REAR END SIDE AT APPROXIMATELY 51MM FROM THE DISTAL END. (II) THE OUTER LAYER HAD BEEN PEELED OFF AND THE WIRE HAD BEEN EXPOSED AT APPROXIMATELY 46MM FROM THE DISTAL END OVER HALF A CIRCUMFERENCE. (III) THE OUTER LAYER HAD BEEN PEELED OFF AT APPROXIMATELY 60MM - 75MM FROM THE DISTAL END. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS: (I) THE PEELED OUTER LAYER HAD A TORN SHAPE ON THE DISTAL SIDE AT APPROXIMATELY 40MM FROM THE DISTAL END. (II) THE FRACTURE SURFACE OF OUTER LAYER WAS SMOOTH. (III) IT HAD BEEN SCRATCHED AND WRINKLED AT APPROXIMATELY 51MM AND 60MM FROM THE DISTAL END. (IV) ARC-SHAPED SCRATCHES WERE FOUND AT APPROXIMATELY 65MM AND 75MM FROM THE DISTAL END. THE OUTER DIAMETER OF ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. SIMULATION TEST. WE HAVE EXPERIENCED PEELING OF THE OUTER LAYER WHEN THE RADIFOCUS GUIDE WIRE M AND THE METAL NEEDLE WERE USED IN COMBINATION. WHEN THE OUTER LAYER WAS PEELED OFF WHEN THIS PRODUCT WAS USED IN COMBINATION WITH A METAL NEEDLE, THE FOLLOWING CHARACTERISTICS WERE OBSERVED: (I) THE OUTER LAYER WAS PEELED OFF OVER HALF A CIRCUMFERENCE, AND THE WIRE WAS EXPOSED. (II) THE FRACTURE SURFACE OF OUTER LAYER WAS SMOOTH. (III) THE PEELED OUTER LAYER HAD A STEEP SLOPE ON THE DISTAL SIDE, WHILE IT HAD A GENTLE SLOPE ON THE REAR END SIDE. THESE CHARACTERISTICS WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF ACTUAL SAMPLE CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. ASHITAKA FACTORY MANUFACTURING PROCESS ASSURES THE QUALITY OF THIS PRODUCT BY PERFORMING FOLLOWING WORK AND INSPECTIONS. (I) THE GUIDEWIRE IS PASSED THROUGH THE DEDICATED TOOL ON 100% BASIS TO CONFIRM THAT THERE IS NO PEELING ON THE OUTER LAYER OR NO FOREIGN SUBSTANCE ON THE SURFACE OF GUIDEWIRE. (II) 100% VISUAL INSPECTION IS PERFORMED TO CONFIRM THAT THERE IS NO PEELING OF THE OUTER LAYER ON THE SURFACE OF GUIDEWIRE. WE HAVE RECONFIRMED THAT THE ABOVE ASSURANCE SYSTEM WAS BEING PERFORMED NORMALLY. FROM RECORD REVIEW SINCE NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD, AND ASSURANCE SYSTEM IN THE MANUFACTURING PROCESS WAS PERFORMED NORMALLY, IT WAS INFERRED THAT THERE WAS NO PROBLEM IN THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR COMPLAINT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. BASED ON RECORD REVIEW, SINCE ASSURANCE SYSTEM IN THE MANUFACTURING PROCESS WAS PERFORMED NORMALLY, AND NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD, IT WAS INFERRED THAT THERE WAS NO PROBLEM IN THE MANUFACTURING PROCESS. FROM THE STATE OF ACTUAL SAMPLE, IT WAS LIKELY THAT SINCE THE ACTUAL SAMPLE WAS OPERATED IN THE REMOVAL DIRECTION WITH THE ACTUAL SAMPLE AND THE METAL NEEDLE USED IN COMBINATION, IT CAME INTO CONTACT WITH THE METAL NEEDLE, AND THE WIRE WAS EXPOSED, AND THE OUTER LAYER WAS SCRATCHED FROM AT APPROXIMATELY 40MM - 75MM FROM THE DISTAL END. IN ADDITION, SINCE THE WIRE WAS EXPOSED APPROXIMATELY 8MM, IT WAS INFERRED THAT A PART OF OUTER LAYER OF THE ACTUAL SAMPLE WAS MISSING. IFU STATES: "DO NOT MANIPULATE OR WITHDRAW THE GUIDEWIRE M 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 INVOLVED RADIFOCUS GUIDEWIRE M PRODUCT WAS PRIMED AFTER OPENING THE PACKAGE. WHEN THE WIRE WAS TAKEN OUT, IT WAS FOUND THAT THE URETHANE HAD PEELED OFF AT THE DISTAL END. IT WAS INFERRED THAT THE EVENT WAS AN INITIAL FAILURE, AND ANOTHER PRODUCT WAS USED TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444056 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 210805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown