BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 14427363 · Received May 18, 2022

    Report

    Report Number
    9681834-2022-00087
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 17, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER, UDI - NOT REQUIRED FOR PRODUCT CODE, IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER, PMA/510(K)- K062858, K082644. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND THAT THE WIRE HAD BEEN EXPOSED AT APPROXIMATELY 23MM - 61MM FROM THE DISTAL END. THE OUTER LAYER HAD BEEN CONNECTED AT APPROXIMATELY 23MM FROM THE DISTAL END. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE SECTION AT APPROXIMATELY 23MM FROM THE DISTAL END OBTAINED FOLLOWING RESULTS. THE OUTER LAYER HAD BEEN PEELED OFF OVER HALF A CIRCUMFERENCE, AND THE WIRE HAD BEEN EXPOSED. THE FRACTURE SURFACE OF OUTER LAYER WAS SMOOTH. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE SECTION AT APPROXIMATELY 61MM FROM THE DISTAL END OBTAINED FOLLOWING RESULTS. THE OUTER LAYER HAD BEEN PEELED OFF OVER HALF A CIRCUMFERENCE, AND THE WIRE HAD BEEN EXPOSED. THE OUTER LAYER HAD BEEN PEELED OFF IN A SPIRAL SHAPE. THE OUTER LAYER HAD BEEN PEELED OFF WITH A GENTLE SLOPE. THE FRACTURE SURFACE OF OUTER LAYER WAS SMOOTH. THE PEELING END WAS ARC SHAPED. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE PEELED OUTER LAYER OBTAINED FOLLOWING RESULTS. A GROOVE WAS FOUND ON THE FRACTURE SURFACE. THE END HAD A SPIRAL SHAPE. THE FRACTURE SURFACE WAS SMOOTH. THE END HAD AN ARC-SHAPE. THE OUTER DIAMETER OF ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. SIMULATION TESTING WAS PERFORMED. WE HAVE EXPERIENCED PEELING OF THE OUTER LAYER WHEN A PLASTIC TYPE GUIDEWIRE AND A METAL NEEDLE WERE USED IN COMBINATION. WHEN THE OUTER LAYER WAS PEELED OFF WHEN USED IN COMBINATION WITH A METAL NEEDLE, THE FOLLOWING CHARACTERISTICS WERE OBSERVED. THE OUTER LAYER WAS PEELED OFF OVER HALF A CIRCUMFERENCE, AND THE WIRE WAS EXPOSED. THE FRACTURE SURFACE OF OUTER LAYER WAS SMOOTH. THE REAR END OF PEELED OUTER LAYER HAD A GENTLE SLOPE. THESE CHARACTERISTICS WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. SINCE THE LOT NUMBER OF ACTUAL SAMPLE WAS UNKNOWN, THE MANUFACTURING RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET COULD NOT BE REVIEWED. IFU STATES: "DO NOT USE A PLASTIC JACKETED MINI GUIDE WIRE WITH A METALLIC ENTRY NEEDLE. WITHDRAWING THE PLASTIC WIRE THROUGH THE METALLIC ENTRY NEEDLE OR ADVANCING THE ENTRY NEEDLE OVER THE PLASTIC JACKETED WIRE MAY CAUSE THE PLASTIC PART TO SHEAR, THAT MAY NECESSITATE RETRIEVAL." BASED ON THE INVESTIGATION RESULT, IT WAS LIKELY THAT WHEN THE ACTUAL SAMPLE AND THE METAL NEEDLE WERE USED IN COMBINATION AND THE ACTUAL SAMPLE WAS OPERATED IN THE REMOVAL DIRECTION, IT CAME INTO CONTACT WITH THE METAL NEEDLE, THE OUTER LAYER WAS PEELED OFF AT APPROX. 23MM - 61MM FROM THE DISTAL END, AND THE WIRE WAS EXPOSED. SINCE THE OUTER LAYER WAS CONNECTED AT APPROX. 23MM FROM THE DISTAL END, AND THE SHAPE OF THE PEELED END OF MAIN BODY AND THE PEELED PIECE END MATCHED, IT WAS PRESUMED THAT THERE WAS NO MISSING PIECE IN THE OUTER LAYER OF ACTUAL SAMPLE. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AFTER OPENING THE INVOLVED PRODUCT, IT WAS CONFIRMED THAT THE SURFACE OF MINI GUIDEWIRE HAS PEELED OFF AT THE PREPARATION STAGE. THEY HAD TO TAKE ANOTHER NEW PRODUCT OUT, AND THEN THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709832 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown