BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 16547524 · Received March 15, 2023

    Report

    Report Number
    9681834-2023-00043
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 15, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO PROVIDE CORRECTIONS TO SECTION D3.

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: OTHER. PMA/510(K): K926214. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN CATALOG AND LOT COMBINATION. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE ACTUAL SAMPLE UPON RECEIPT WAS ONLY THE FRACTURED PIECE. VISUAL INSPECTION OF THE SAMPLE FOUND THAT THE FRACTURED PIECE WAS APPROXIMATELY 66 MILLIMETERS (MM). MAGNIFYING INSPECTION OF THE SAMPLE FOUND THAT ONE END OF THE FRACTURED PIECE HAD BEEN TIP PROCESSED. THE SUBSEQUENT INVESTIGATION WAS PERFORMED WITH THE PROCESSED ONE END WAS DEFINED AS THE DISTAL END AND THE DISTAL END WAS STRAIGHT. THE SURFACE OF OUTER LAYER HAD BEEN WHITENED IN THREE SECTIONS (APPROXIMATELY 10MM, 15MM AND 22MM - 27MM FROM THE DISTAL END). THE OUTER LAYER HAD BEEN PEELED OFF AND THE WIRE HAD BEEN EXPOSED AT THE MIDDLE SECTION (APPROXIMATELY 30MM - 40MM FROM THE DISTAL END). THE OUTER LAYER HAD BEEN PEELED OFF AND THE WIRE HAD BEEN EXPOSED IN THE VICINITY OF FRACTURED SECTION (APPROXIMATELY 62MM - 66MM FROM THE DISTAL END). IN THE VICINITY OF EACH EXPOSED SECTION OF THE WIRE HAD BEEN WHITENED. THE AREA IN THE VICINITY FRACTURED SECTION OF WIRE HAD BEEN DISCOLORED TO A BURNT COLOR. THEREFORE, IT WAS INFERRED THAT A HEAT LOAD WAS APPLIED TO THE FRACTURED SECTION OF WIRE. SINCE THE DETAILED PRODUCT CODE OF THIS CASE WAS UNKNOWN, RF-GA35153, WHICH HAS BEEN THE MOST USED PRODUCT IN THE FACILITY, WAS ENTERED IN THE ISSUED REPORT AS AN ESTIMATED PRODUCT CODE. HOWEVER, ACCORDING TO THE INVESTIGATION, THE SHAPE OF THE DISTAL END OF ACTUAL SAMPLE WAS STRAIGHT. SINCE THE ESTIMATED PRODUCT CODE AT THE TIME OF ISSUING THE PPR HAD AN ANGLE SHAPE, IT WAS DIFFERENT FROM THE ACTUAL SAMPLE. THEREFORE, THE PRODUCT CODE IN THIS CASE TO BE UNKNOWN. ELECTRON MICROSCOPIC INSPECTION FOUND THAT THE FRACTURED SURFACE OF THE EXPOSED SECTION OF WIRE WAS CONFIRMED. SINCE THE WHITENED AREA WAS EXTREMELY ROUGH, IT WAS NOT POSSIBLE TO CLARIFY THE SHAPE OF FRACTURED SURFACE. COMPONENT ANALYSIS OF WHITENED AREA (FT-IR). THE SPECTRUM OF WHITENED AREA WAS VERY SIMILAR TO THAT OF THE OUTER LAYER OF GUIDEWIRE. FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY METHOD): AN ANALYSIS METHOD TO CONFIRM THE MOLECULAR STRUCTURE OF AN OBJECT BY ANALYZING THE SPECTRUM OBTAINED BY IRRADIATING THE MEASUREMENT TARGET WITH INFRARED RAYS. SINCE THE WAVELENGTH OF THE INFRARED ABSORBED IS ALMOST UNIQUE TO EACH SUBSTANCE, QUALITATIVE ANALYSIS OF THE SUBSTANCE IS POSSIBLE BY COMPARING IT WITH THE INFRARED STANDARD ABSORPTION SPECTRUM. ELECTRON MICROSCOPIC INSPECTION OF WIRE AFTER REMOVING THE OUTER LAYER FOUND THAT THE SIDE OF WIRE HAD BEEN MELTED AND DEFORMED. THE WIRE HAD CONCAVE AND CONVEX SHAPES AND THE FRACTURED SURFACE OF WIRE HAD DIMPLE PATTERNS. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE SINCE THE PRODUCT CODE AND THE LOT NUMBER WERE UNKNOWN, THEY WERE UNABLE TO INVESTIGATE. SINCE THE PRODUCT CODE AND THE LOT NUMBER WERE UNKNOWN, IT WAS UNABLE TO INVESTIGATE. FROM THE CONDITION OF ACTUAL SAMPLE, IT WAS INFERRED THAT SINCE A HEAT LOAD WAS APPLIED TO THE SIDE SURFACE OF GUIDEWIRE, THE WIRE WAS DEFORMED AND ITS STRENGTH WAS LOWERED, AND THE GUIDEWIRE WAS IN A STATE WHERE IT WAS EASY TO FRACTURE. THEREFORE, A HEAT LOAD WAS APPLIED TO THE SIDE OF FACTORY-RETAINED GUIDEWIRE AT APPROXIMATELY 66MM FROM THE DISTAL END (THE SAME POSITION AS THE FRACTURED SECTION OF ACTUAL SAMPLE). MAGNIFYING INSPECTION OF THE SIMULATED PRODUCT FOUND THAT THE OUTER LAYER WAS MELTED, AND THE WIRE WAS EXPOSED. THE WIRE WAS DISCOLORED TO A BURNT COLOR. THE OUTER LAYER WAS WHITENED. THE DISCOLORATION STATE OF WIRE AND WHITENED AREA WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE, BUT NO DEFORMATION OF THE WIRE WAS FOUND. IT WAS INFERRED TO BE BECAUSE THE AMOUNT OF HEAT APPLIED TO THE SIMULATED PRODUCT WAS SMALLER THAN THE AMOUNT OF HEAT APPLIED TO THE ACTUAL SAMPLE. BASED ON OUR PAST KNOWLEDGE, THE FOLLOWING SIMULATION TEST WAS PERFORMED FOR THE FRACTURE OF GUIDEWIRE APPLYING REPEATED BENDING FORCE. WHEN REPEATED BENDING FORCE WAS APPLIED, NO TAPER WAS FOUND ON THE FRACTURED SECTION OF WIRE, AND IT WAS FLAT. DIMPLE PATTERNS (HOLE-SHAPED PATTERNS) WERE FOUND ON THE FRACTURED SURFACE. FROM THE TEST RESULT, IT WAS LIKELY TO BE PARTIALLY SIMILAR TO THE CONDITION OF ACTUAL SAMPLE. IT WAS LIKELY THAT SINCE A HEAT LOAD WAS APPLIED TO THE ACTUAL SAMPLE, THE WIRE WAS MELTED AND ITS STRENGTH WAS LOWERED, AND THE GUIDEWIRE WAS IN A STATE WHERE IT WAS EASY TO FRACTURE. IN THIS STATE, REPEATED BENDING FORCE WAS APPLIED TO THE ACTUAL SAMPLE, AND THE WIRE AT APPROXIMATELY 66MM FROM THE DISTAL END FRACTURED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE GUIDE WIRE M, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE GUIDE WIRE M. FOR EXAMPLE, WHEN USING THE GUIDEWIRE M WITH ANY DEVICE THAT EMITS ENERGY (LASER, PRESSURE, ULTRASOUND, ETC.) CONFIRM THAT THE GUIDE WIRE M IS RETRACTED INTO A POSITION WHERE IT WILL NOT BE IMPACTED BY THE ENERGY." 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 THAT THE GUIDEWIRE INVOLVED WAS USED ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT'S URETERAL SIDE WAS VISUALLY OBSERVED FROM THE SUPERIOR CALYX OF THE KIDNEY (THE URETERAL SIDE WAS TORN). A SURGICAL PROCEDURE WAS PERFORMED TO RETRIEVE THE FRACTURED PIECE, IT WAS RETRIEVED BY MAKING AN INCISION. THE PROCEDURE OUTCOME WAS NOT REPORTED. NO FRACTURED PIECE REMAINED IN THE PATIENT'S BODY AFTER THE RETRIEVAL. THE PATIENT WAS IN STABLE CONDITION AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114330 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O