BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 23653519 · Received November 26, 2025

    Report

    Report Number
    9681834-2025-00220
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI NO. N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. E3: OCCUPATION: REQUESTED, UNKNOWN. G4: 510(K) NUMBER: K955801, K170417. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. APPEARANCE CONFIRMATION OF THE ACTUAL DEVICE. FRACTURED PIECE: APPROXIMATELY 77MM. MAIN PART: APPROXIMATELY 1723MM. APPEARANCE CONFIRMATION OF THE ACTUAL DEVICE. [FRACTURED PIECE] - THE ELONGATION OF THE OUTER LAYER AND THE SHAPE THAT SEEMED TO BE TORN OFF WERE OBSERVED AT THE FRACTURED PART. - THE EXPOSURE OF THE WIRE STRAND WAS OBSERVED AT THE FRACTURED PART. - NO ANOMALY SUCH AS ABRASION WAS FOUND IN APPEARANCE IN OTHER PARTS. [MAIN PART] - THE ELONGATION OF THE OUTER LAYER AND THE SHAPE THAT SEEMED TO BE TORN OFF WERE OBSERVED AT THE FRACTURED PART. - NO EXPOSURE OF WIRE STRAND WAS OBSERVED AT THE FRACTURED PART. - NO ANOMALY SUCH AS ABRASION WAS FOUND IN APPEARANCE IN OTHER PARTS. APPEARANCE CONFIRMATION OF THE WIRE STRAND: THE WIRE STRAND OF THE FRACTURED PART OF FRACTURED PIECE WAS VISUALLY CONFIRMED BY AN ELECTRON MICROSCOPE. - NO TAPER WAS OBSERVED ON THE SIDE OF THE WIRE STRAND. - RADIAL PATTERNS WERE OBSERVED ON THE TOP OF THE WIRE STRAND. DIMENSIONS: THE OUTER DIAMETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. LENGTH OF MISSING PORTION: - FRACTURED PIECE: APPROXIMATELY 77MM. - MAIN PART: APPROXIMATELY 1723MM. TOTAL LENGTH: APPROXIMATELY 1800MM. SINCE THE CURRENT PRODUCT IS APPROX. 1800MM, IT IS CONSIDERED THAT THERE IS NO MISSING PORTION. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER: NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO SIMILAR EVENT WAS FOUND IN THE PAST COMPLAINT FILE. SIMULATION TEST: IT WAS FRACTURED BY APPLYING CONTINUOUS TORQUE LOAD IN THE SAME DIRECTION IN A CURVED STATE. NO TAPER WAS OBSERVED ON THE SIDE OF THE WIRE STRAND. RADIAL PATTERNS WERE OBSERVED ON THE TOP OF THE WIRE STRAND. IT WAS CONSIDERED TO BE SIMILAR TO THE CONDITION OF ACTUAL DEVICE. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND DIMENSIONS OF THE ACTUAL DEVICE. FROM THE CONDITION OF THE ACTUAL DEVICE AND THE SIMULATION TEST, AS ONE OF THE POSSIBILITIES, IT WAS CONSIDERED THAT REPEATED TORQUE LOAD WAS APPLIED TO THE INVOLVED PART IN THE SAME DIRECTION WHILE IT WAS CURVED, LEADING TO THE FRACTURE OF THE WIRE STRAND. IT WAS ALSO INFERRED THAT THE OUTER LAYER WAS SUBSEQUENTLY TORN OFF WHEN THE TENSILE LOAD AND TORQUE LOAD WERE APPLIED DURING REMOVAL. IT WAS THOUGHT THAT THERE WAS NO MISSING PORTION IN THE ACTUAL DEVICE. RELEVANT IFU REFERENCE: - MANIPULATE THE GLIDEWIRE GT SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY TO AVOID DAMAGE TO THE VESSEL. IF ANY RESISTANCE IS FELT, THE BEHAVIOR AND/OR POSITION OF THE WIRE'S TIP SEEMS IMPROPER, THE WIRE IS KINKED, OR VESSEL SPASM IS SUSPECTED, STOP MANIPULATING THE WIRE (AND THE CATHETER) AND DETERMINE THE CAUSE CAREFULLY BY FLUOROSCOPY TO TAKE SUITABLE REMEDIAL ACTIONS. THEN REMOVE THE WIRE SLOWLY WITHOUT TURNING. 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. - DO NOT TURN THE PROXIMAL END OF THE GLIDEWIRE GT THREE OR MORE TURNS IN SUCCESSION IN THE SAME DIRECTION IF THE WIRE'S TIP IS TRAPPED DUE TO VESSEL SPASM OR SOME OTHER CAUSE. SEPARATION OF THE WIRE MAY RESULT. TERUMO MEDICAL CORPORATION (TMC) (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

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GUIDEWIRE BROKE OFF DURING MANIPULATION IN THE CATHETER THROMBECTOMY PROCEDURE. BOTH THE BLOOD CLOT THAT WAS PLANNED FOR REMOVAL AND THE DISTAL END OF THE BROKEN WIRE WERE SUCCESSFULLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THE WIRE FRACTURED INSIDE THE BODY AND WAS REMOVED ALONG WITH A THROMBUS. THEREFORE, IT WAS DETERMINED TO BE A SERIOUS INJURY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569515 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RG-GA1618F 241017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention