BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 16022768 · Received December 21, 2022

    Report

    Report Number
    9681834-2022-00254
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 21, 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): K863138,K926214. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION OF THE ACTUAL SAMPLE UPON RECEIPT REVEALED THE FOLLOWING: A GUIDEWIRE, ITS PEELING PIECE, A METAL NEEDLE. VISUAL, MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS WERE PERFORMED ON THE PEELED PIECE REVEALED THE FOLLOWING: TOTAL LENGTH: APPROXIMATELY 63MM. IT HAD BEEN HOLLOWED ALONG THE ENTIRE LENGTH. ONE END WAS AN ARC-SHAPED. THE FRACTURE SURFACE WAS SMOOTH. VISUAL, MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS WERE PERFORMED ON THE GUIDEWIRE REVEALED THE FOLLOWING: THE OUTER LAYER HAD BEEN PEELED OFF AT APPROXIMATELY 792MM - 855MM FROM THE DISTAL END (APPROXIMATELY 63MM), AND THE WIRE HAD BEEN EXPOSED. WHEN THE OUTER LAYER PEELED SECTION AND THE PEELING PIECE WERE OVERLAPPED, THEY MATCHED. THEREFORE, IT WAS INFERRED THAT THERE WAS NO MISSING PIECE AT THIS PART. THERE WAS A STEP AT APPROXIMATELY 792MM FROM THE DISTAL END. THE WIRE HAD BEEN EXPOSED OVER HALF THE CIRCUMFERENCE. THE END AT APPROXIMATELY 855MM FROM THE DISTAL END WAS AN ARC-SHAPED, AND HAD A GENTLE SLOPE. THE OUTER LAYER HAD BEEN INTERMITTENTLY SHAVED AT APPROXIMATELY 860MM - 880MM FROM THE DISTAL END. IT HAD BEEN INTERMITTENTLY ROUGHENED AT APPROXIMATELY 890MM - 1005MM FROM THE DISTAL END. NO ANOMALY SUCH AS PEELING OF THE OUTER LAYER WAS FOUND IN OTHER SECTIONS. THE FRACTURE SURFACE OF PEELED OUTER LAYER AND THE FRACTURE SURFACE OF SHAVED OUTER LAYER WERE SMOOTH. SOME PARTS OF THE OUTER LAYER HAD SCRATCHES AND ARC-SHAPED WRINKLES. DIMENSIONS OF THE NORMAL SECTION WERE TAKEN WITH THE FOLLOWING RESULTS: THE NORMAL SECTION OF OUTER DIAMETER MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. SIMULATION TESTING WAS PERFORMED. WE HAVE EXPERIENCED THAT WHEN USING RADIFOCUS GUIDE WIRE M AND A METAL NEEDLE IN COMBINATION, THE OUTER LAYER PEELED OFF. WHEN THE OUTER LAYER PEELED OFF DUE TO USE WITH A METAL NEEDLE, THE FOLLOWING CHARACTERISTICS WERE OBSERVED: THE OUTER LAYER WAS PEELED OFF OVER HALF THE CIRCUMFERENCE, AND THE WIRE WAS EXPOSED. THE FRACTURE SURFACE OF OUTER LAYER WAS SMOOTH. THERE WAS A STEP ON THE DISTAL SIDE OF PEELED OUTER LAYER. THE REAR END OF PEELED OUTER LAYER WAS AN ARC-SHAPED, AND HAD A GENTLE SLOPE. THESE CHARACTERISTICS WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. DEVICE HISTORY INVESTIGATION: THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE. SINCE THE LOT NUMBER WAS UNKNOWN, THEY COULD NOT BE REVIEWED. PAST COMPLAINT FILE INVESTIGATION: SINCE THE LOT NUMBER WAS UNKNOWN, THEY COULD NOT BE SEARCHED. IT WAS LIKELY THAT SINCE THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH A METAL NEEDLE, AND IT WAS OPERATED IN THE REMOVAL DIRECTION, IT CAME INTO CONTACT WITH THE METAL NEEDLE AND THE OUTER LAYER WAS PEELED OFF. REGARDING THE PEELED SECTION OF OUTER LAYER AT APPROXIMATELY 792MM - 855MM FROM THE DISTAL END, SINCE IT MATCHED THE PEELING PIECE, IT WAS INFERRED THAT THERE WAS NO MISSING PIECE OF THE OUTER LAYER. HOWEVER, REGARDING THE SECTION AT APPROXIMATELY 860MM - 880MM FROM THE DISTAL END, SINCE THE OUTER LAYER WAS INTERMITTENTLY SHAVED, IT WAS INFERRED THAT A PART OF OUTER LAYER 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." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 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 INVOLVED RADIFOCUS GUIDEWIRE M PRODUCT WAS USED IN A FEMORAL PUNCTURE FOR THE BLOOD VESSEL PROSTHESIS IMPLANTATION. SINCE IT WAS USED IN COMBINATION WITH A METAL NEEDLE, THE URETHANE WAS PEELED OFF. IT IS UNKNOWN WHETHER THE PEELED PIECE HAS BEEN REMAINING IN THE PATIENT'S BODY. HOWEVER, THE POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO ANOMALY, AND THE PATIENT'S CONDITION IS GOOD AT THIS TIME. THE PROCEDURE OUTCOME WAS NOT REPORTED. IT IS UNKNOWN WHETHER OR NOT THE PEELED PIECE REMAINED IN THE PATIENT'S BODY OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456515 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown METAL NEEDLE