BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 15727660 · Received November 4, 2022

    Report

    Report Number
    9681834-2022-00225
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 3, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K863138, K926214. (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND THAT THE CORE WIRE WAS EXPOSED IN THE AREA APPROXIMATELY 23MM - 105 MM FROM THE DISTAL END. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE OBTAINED THE FOLLOWING RESULT: (I) APPROXIMATELY 87 MM OF THE OUTER LAYER WAS MISSING FROM THE AREA APPROXIMATELY 23MM TO 110MM FROM THE DISTAL END; (II) INTERMITTENT SCRATCHES WERE OBSERVED IN THE AREA APPROXIMATELY 4MM - 23MM FROM THE DISTAL END; (III) THE EDGE OF OUTER LAYER AT APPROXIMATELY 23MM FROM THE DISTAL END WAS STRAIGHT AND A STEPPED; (IV) THE CORE WIRE WAS EXPOSED OVER HALF THE CIRCUMFERENCE; (V) THE OUTER LAYER HAD BEEN PEELED OFF AT A GENTLE SLOPE AT APPROXIMATELY 110MM FROM THE DISTAL END AND THE END SECTION WAS ARCUATE. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE PEELED SURFACE OF THE OUTER LAYER WAS SMOOTH. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE FACTORY'S SPECIFICATION. NO ANOMALY WAS OBSERVED. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. WE EXPERIENCED THAT WHEN A RADIFOCUS GUIDEWIRE M WAS USED IN COMBINATION WITH A METAL NEEDLE, THE OUTER LAYER PEELED OFF. THE FOLLOWING CHARACTERISTICS WERE OBSERVED WHEN THE OUTER LAYER PEELED OFF DUE TO COMBINATION USE WITH A METAL NEEDLE. THE CORE WIRE WAS EXPOSED OVER HALF THE CIRCUMFERENCE, THE PEELED OUTER LAYER SURFACE WAS SMOOTH, THE DISTAL END OF THE PEELED OUTER LAYER WAS STRAIGHT AND STEPPED AND THE PROXIMAL END OF THE PEELED OUTER LAYER WAS ARC-SHAPED AND GENTLY SLOPED. THESE CHARACTERISTICS WERE LIKE THOSE OBSERVED ON THE ACTUAL SAMPLE. BASED ON THE INVESTIGATION RESULTS AND THE CONTENTS OF THE COMPLAINT, IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS MANIPULATED IN THE WITHDRAWAL DIRECTION WHILE IT WAS USED IN CONJUNCTION WITH THE METAL NEEDLE, WHICH RESULTED IN THE PEELING OF OUTER LAYER. THE MISSING LENGTH OF THE OUTER LAYER WAS ESTIMATED TO BE APPROXIMATELY 87MM. RELEVANT IFU (INSTRUCTIONS FOR USE) REFERENCE: " DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE 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. (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 INVOLVED RADIFOCUS GUIDEWIRE WAS USED IN A URINARY TRACT PROCEDURE, HOWEVER THE COATING ON THE DISTAL END PEELED OFF AND THE PEELED PORTION REMAINED IN THE RENAL PELVIS. IT WAS USED IN CONJUNCTION WITH A METAL NEEDLE. IT WAS INSERTED DIRECTLY INTO THE NEPHROSTOMY, THE WIRE GOT CAUGHT, REMOVED SUCCESSFULLY WHEN PULLED, BUT THE COATING ON THE DISTAL END WAS FOUND TO HAVE PEELED OFF. CURRENTLY THE FRAGMENT REMAINS IN THE BODY AND WILL BE TREATED IN THE FUTURE. THE EVENT OCCURRED INTRA-OPERATIVE. THE PROCEDURE OUTCOME WAS RESIDUAL IN THE PATIENT (PLANNED TO BE RETRIEVED). THE PATIENT'S FINAL IMPACT WAS HARMED BUT NOT SERIOUSLY. A PORTION OF URETHANE WAS SEPARATED AND CURRENTLY REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797726 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 220425YA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other