BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 23251430 · Received October 8, 2025

    Report

    Report Number
    9681834-2025-00184
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 8, 2025
    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

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE INVOLVED LOT # WAS NOT PROVIDED G4: 510K: K863138, K923607, K926214. THE RETURNED DEVICE CONSISTED OF THE GUIDEWIRE MAIN BODY ONLY. APPROXIMATELY 35 MM OF THE WIRE WAS EXPOSED. MICROSCOPIC INSPECTION REVEALED THAT THE OUTER LAYER HAD BEEN ELONGATED, WITH A TORN APPEARANCE OBSERVED APPROXIMATELY 32 MM FROM THE DISTAL END. THE OUTER LAYER WAS MISSING FROM THE DISTAL END TO APPROXIMATELY 35 MM FROM THE DISTAL END. THE FRACTURED SURFACE OF THE OUTER LAYER WAS SMOOTH. THE REAR END OF THE PEELED OUTER LAYER EXHIBITED AN ARC SHAPE WITH A GENTLE SLOPE. PEELING OF THE OUTER LAYER WAS ALSO OBSERVED AT APPROXIMATELY 40 MM FROM THE DISTAL END. INTERMITTENT ABRASIONS WERE NOTED BETWEEN APPROXIMATELY 35 MM AND 45 MM FROM THE DISTAL END. NO ANOMALIES SUCH AS PEELING, SCRATCHES, OR KINKS WERE OBSERVED IN OTHER SECTIONS OF THE GUIDEWIRE. ELECTRON MICROSCOPIC INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE AND A CURRENT PRODUCTION SAMPLE. FIXED SIZE CUT MARKS, CONSISTENT WITH THOSE THAT OCCUR DURING THE WIRE CUTTING PROCESS IN MANUFACTURING, WERE OBSERVED ON THE TOP SURFACE OF THE WIRE. CONFIRMATION OF THE OUTER DIAMETER DIMENSIONS AT THE NORMAL SECTIONS MET THE FACTORY'S SPECIFICATIONS; NO ANOMALIES WERE FOUND. THE WIRE HAD BEEN EXPOSED APPROXIMATELY 35 MM AT THE DISTAL END. IT WAS INITIALLY CONSIDERED THAT THE OUTER LAYER AT THE DISTAL END MAY HAVE BEEN MISSING APPROXIMATELY 35 MM. HOWEVER, FIXED SIZE CUT MARKS WERE OBSERVED ON THE TOP SURFACE OF THE WIRE ON BOTH THE ACTUAL DEVICE AND A CURRENT PRODUCT. BASED ON THIS OBSERVATION, IT IS LIKELY THAT THERE WAS NO MISSING LENGTH ON THE WIRE. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT #. SINCE THE LOT # WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. IN THE PAST TWO YEARS, WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS OF THE INVOLVED PRODUCTS CAUSED BY THE MANUFACTURING PROCESS. A SIMULATION TEST WAS CONDUCTED USING A RADIFOCUS GUIDE WIRE M IN COMBINATION WITH A METAL NEEDLE. DURING THE TEST, THE OUTER LAYER OF THE GUIDE WIRE WAS OBSERVED TO BE PEELED OFF OVER MORE THAN HALF OF ITS CIRCUMFERENCE, EXPOSING THE WIRE. THE FRACTURED SURFACE OF THE OUTER LAYER APPEARED SMOOTH. THE DISTAL SIDE OF THE PEELED SECTION WAS LINEAR WITH A NOTICEABLE STEP, WHILE THE REAR END SIDE EXHIBITED A GENTLE SLOPE. THESE CONDITIONS WERE CONSIDERED SIMILAR TO THOSE OBSERVED ON THE ACTUAL DEVICE. BASED ON THE FINDINGS, IT WAS DETERMINED THAT THE OUTER LAYER OF THE ACTUAL DEVICE HAD BEEN ELONGATED AND EXHIBITED A TORN SHAPE. IT IS LIKELY THAT THE DEVICE CAME INTO CONTACT WITH A SHARP, HARD OBJECT SUCH AS A METAL NEEDLE, WHICH CAUSED PART OF THE OUTER LAYER TO PEEL OFF. A PULLING FORCE WAS THEN APPLIED, LEADING TO FRACTURE OF THE ACTUAL DEVICE. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS LIKELY THAT A SHARP, HARD OBJECT SUCH AS A METAL NEEDLE CAUSED THE ABRASIONS ON THE OUTER LAYER AND PEELING OF THE URETHANE, AND PART OF IT FRACTURED. WHEN THE DEVICE WAS SUBSEQUENTLY REMOVED, PULLING FORCE WAS APPLIED, CAUSING THE OUTER LAYER TO ELONGATE AND TEAR, RESULTING IN DETACHMENT. IN ADDITION, IT WAS LIKELY THAT THERE WAS NO MISSING LENGTH IN THE WIRE OF ACTUAL DEVICE, AND THE OUTER LAYER AT THE DISTAL END WAS MISSING APPROXIMATELY 35 MM. RELEVANT INSTRUCTIONS FOR USE (IFU) 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. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5. ACTUAL DEVICES UPON RECEIPT: TWO FRACTURED PIECES. MICROSCOPIC INSPECTION: THE OUTER LAYER HAD BEEN ELONGATED, AND TORN SHAPES WERE FOUND AT THE FRACTURED SECTIONS OF FRACTURED PIECES. COMBINATION TEST OF THE ACTUAL DEVICE (VISUAL INSPECTION): TWO FRACTURED PIECES WERE COMBINED WITH THE MAIN BODY. SINCE THE SHAPES OF EACH END MATCHED, IT WAS LIKELY THAT THERE WAS NO MISSING PART. BASED ON THE INVESTIGATION RESULT, SINCE THE OUTER LAYER OF FRACTURED PIECES WERE ELONGATED AND TORN SHAPES WERE FOUND, IT WAS LIKELY THAT WHEN THE DEVICE WAS REMOVED, PULLING FORCE WAS APPLIED TO ITS DISTAL END, CAUSING IT TO FRACTURE.

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED INFORMATION THAT DURING A CATHETERIZATION PROCEDURE USING A CENTRAL VENOUS PORT (BARD), DIFFICULTY WAS ENCOUNTERED IN SELECTING THE SUBCLAVIAN VEIN FROM THE RIGHT INTERNAL JUGULAR VEIN. A METAL NEEDLE AND A RADIFOCUS GUIDEWIRE WERE USED IN COMBINATION. DUE TO RESISTANCE DURING MANIPULATION, BOTH COMPONENTS WERE REMOVED FROM THE PATIENT'S BODY. IT WAS SUBSEQUENTLY FOUND THAT THE DISTAL END OF THE GUIDEWIRE REMAINED IN THE INTERNAL JUGULAR VEIN. THE EVENT OCCURRED INTRA-OPERATIVELY. AN OPERATION TO REMOVE THE REMAINING FOREIGN MATERIAL IS UNDER CONSIDERATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 26SEP2025: THE FRACTURED PIECES REMAINING INSIDE THE PATIENT'S BODY AND WERE RETRIEVED. THE RETRIEVED FRACTURED PIECES WERE RECEIVED BY ASHITAKA FACTORY FOR INVESTIGATION ON SEPTEMBER 29, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616899 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA35083 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CENTRAL VENOUS PORT (BARD MEDICAL)