BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 16550920 · Received March 15, 2023

    Report

    Report Number
    9681834-2023-00046
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 14, 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
    PHYSICIAN
    Health Professional
    Yes

    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

    PMA/510(K): K926214. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. A SEARCH OF THE PAST COMPLAINT FILE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. INSPECTION OF THE ACTUAL SAMPLE: VISUAL, MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS FOUND THAT: - THE OUTER LAYER HAD PEELED OFF AT APPROXIMATELY 74 MM - 188 MM FROM THE DISTAL END (APPROXIMATELY 114 MM IN LENGTH), EXPOSING THE CORE WIRE. IT WAS CONSIDERED THAT APPROXIMATELY 114 MM OF THE OUTER LAYER WAS MISSING FROM THE PEELED SITE. - THE END OF THE PEELED SITE AT APPROXIMATELY 74 MM FROM THE DISTAL END WAS STRAIGHT WITH A STEP. - PEELING OF OUTER LAYER HAD OCCURRED HALF THE CIRCUMFERENCE WITH EXPOSURE OF CORE WIRE. - THE END AT APPROXIMATELY 188MM FROM THE DISTAL END WAS AN ARC-SHAPED WITH A GENTLE SLOPE. - THE OUTER LAYER HAD BEEN SHAVED INTERMITTENTLY AT APPROXIMATELY 190 MM - 200 MM FROM THE DISTAL END. - THERE ARE SEVERAL ARC-SHAPED SCRATCHES AT APPROXIMATELY 210 MM FROM THE DISTAL END. - THE SURFACE OF THE PEELED OR SHAVED OUTER LAYER WAS SMOOTH. DIMENSIONS: THE OUTER DIAMETER AT THE UNDAMAGED PART MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. SIMULATION TEST: WE HAVE EXPERIENCED THAT WHEN RADIFOCUS GUIDE WIRE M IS USED IN COMBINATION WITH A METAL NEEDLE, THE OUTER LAYER MAY PEEL OFF. WHEN THE OUTER LAYER PEELS OFF DUE TO COMBINATION USE WITH A METAL NEEDLE, THE FOLLOWING CHARACTERISTICS CAN BE OBSERVED. - THE OUTER LAYER PEELS OFF HALF THE CIRCUMFERENCE WITH EXPOSURE OF CORE WIRE. - THE PEELED SURFACE OF OUTER LAYER IS SMOOTH. - THE DISTAL END OF THE PEELED SITE IS STRAIGHT WITH A STEP. - THE PROXIMAL END OF THE PEELED SITE IS ARC-SHAPED WITH A GENTLE SLOPE. THESE CHARACTERISTICS WERE CONSIDERED TO BE SIMILAR TO THOSE OF THE ACTUAL SAMPLE. IT WAS LIKELY THAT THE ACTUAL SAMPLE WAS OPERATED IN THE REMOVAL DIRECTION WHEN USED IN COMBINATION WITH A METAL NEEDLE, THEREBY IT CAME INTO CONTACT WITH THE METAL NEEDLE AND THE OUTER LAYER WAS PEELED OFF. THE MISSING LENGTH OF THE OUTER LAYER PEELED OFF FROM APPROXIMATELY 74 MM - 188 MM FROM THE DISTAL END WAS CONCEIVABLE TO BE APPROXIMATELY 114 MM. IN ADDITION, REGARDING THE PART APPROXIMATELY 190 MM - 200 MM FROM THE DISTAL END, SINCE THE OUTER LAYER WAS CONFIRMED TO HAVE BEEN SHAVED INTERMITTENTLY, IT WAS INFERRED THAT A PART OF OUTER LAYER WAS MISSING FROM THIS PART. 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. (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 DURING PTP PROCEDURE, A METAL NEEDLE (UB COMPATIBLE) WAS USED FOR THE INSERTION OF THE GUIDEWIRE. AFTER THE METAL NEEDLE WAS REMOVED, A SHEATH AND AN ANGIOGRAPHIC CATHETER WERE PLACED, AND THE GUIDEWIRE WAS REMOVED. DURING THIS PROCESS, HAVING A SENSE OF DISCOMFORT, THE PHYSICIAN EXAMINED THE GUIDEWIRE AND NOTICED THAT A PART OF THE GUIDEWIRE HAD PEELED. A FRAGMENT OF THE GUIDEWIRE APPEARED TO HAVE REMAINED IN A VESSEL. REMAINING FRAGMENTS WILL BE REMOVED IN THE FUTURE. THERE ARE CURRENTLY NO CHANGES IN THE PATIENT'S CONDITION DUE TO THE REMAINING FRAGMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. CURRENTLY, THERE IS NO EVIDENCE OF POOR PHYSICAL CONDITION DUE TO URETHANE RESIDUES. THERE ARE RESIDUES IN THE BODY (TO BE COLLECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496315 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other METAL NEEDLE