BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO RADIFOCUS GUIDE WIRE

    MDR report key: 22393929 · Received July 3, 2025

    Report

    Report Number
    9681834-2025-00121
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 3, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOTE EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. G4: 510(K): K955801, K170417. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. 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 UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ACTUAL DEVICE UPON RECEIPT: A FRACTURED PIECE, A GUIDEWIRE MAIN BODY. MICROSCOPIC INSPECTION: [FRACTURED PIECE] IT HAD BEEN ABRADED AT APPROXIMATELY 70MM - 245MM FROM THE DISTAL END. NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. [GUIDEWIRE MAIN BODY] IT HAD BEEN ABRADED AT APPROXIMATELY 1100MM - 1150MM FROM THE FRACTURED SECTION. NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. ELECTRON MICROSCOPIC INSPECTION: A TORN SHAPE WAS FOUND IN EACH FRACTURED SECTION. THE OUTER LAYER HAD BEEN ELONGATED AT THE FRACTURED SECTION OF GUIDEWIRE MAIN BODY. ELECTRON MICROSCOPIC INSPECTION OF THE WIRE: THE OUTER LAYER OF ACTUAL DEVICE WAS REMOVED TO CONFIRM THE CONDITION OF WIRE AT THE FRACTURED SECTION. NO TAPER WAS FOUND ON THE SIDE SURFACE OF WIRE AT EACH FRACTURED SECTION. RADIAL PATTERNS WERE FOUND ON THE TOP SURFACE OF WIRE AT EACH FRACTURED SECTION. CONFIRMATION OF DIMENSIONS (THICKNESS GAUGE): OUTER DIAMETER AT THE NORMAL SECTIONS MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. MISSING LENGTH: FRACTURED PIECE: APPROXIMATELY 254MM. GUIDEWIRE MAIN BODY: APPROXIMATELY 1747MM, TOTAL LENGTH: APPROXIMATELY 2001MM. SINCE THE TOTAL LENGTH OF CURRENT PRODUCT IS 2000MM, IT WAS LIKELY THAT THERE WAS NO MISSING LENGTH. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST. SIMULATION TEST: CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION WHILE THE DEVICE WAS BENT UNTIL THE WIRE FRACTURED. NO TAPER WAS FOUND ON THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION. RADIAL PATTERNS WERE FOUND ON THE TOP SURFACE OF WIRE AT THE FRACTURED SECTION. THESE CONDITIONS WERE LIKELY TO BE SIMILAR TO THOSE OF THE ACTUAL DEVICE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND DIMENSIONS OF THE ACTUAL DEVICE. FROM THE CONDITIONS OF ACTUAL DEVICE AND SIMULATION TEST RESULT, AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS LIKELY THAT SINCE CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION WHILE THE DEVICE WAS BENT, THE WIRE WAS FRACTURED. WHEN THE DEVICE WAS SUBSEQUENTLY REMOVED, PULLING FORCE WAS APPLIED, CAUSING THE OUTER LAYER TO ELONGATE AND TEAR, RESULTING IN DETACHMENT. SINCE THE TOTAL LENGTH OF ACTUAL DEVICE WAS EQUIVALENT TO THAT OF THE CURRENT PRODUCT, IT WAS LIKELY THAT THERE WAS NO MISSING LENGTH IN THE ACTUAL DEVICE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "THE IFU OF THIS PRODUCT INCLUDES THE FOLLOWING WARNINGS." "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."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT GUIDEWIRE BROKE OFF. THE TERUMO GUIDEWIRE GT WAS USED IN COMBINATION WITH MERIT MAESTRO TO TREAT PAE, THE DISTAL TIP OF THE GT WAS EXTENDED 4-5 CM FROM THE CATHETER, AND IT WAS NOTICED THERE WAS NOT A RESPONSE FROM THE WIRE AT ALL. BOTH THE WIRE AND CATHETER WERE REMOVED FROM THE PATIENT, AND IT WAS THEN NOTED THAT THE DISTAL 20CM OF THE WIRE HAD SNAPPED OFF, WHICH REMAINED WITHIN THE CATHETER ON EXTRACTION. THERE WAS NO HARM OR INJURY TO THE PATIENT, AND A NEW CATHETER AND WIRE WERE USED. THE PATIENT WAS TREATED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491734 TERUMO RADIFOCUS GUIDE WIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RG*GA1620FM 240621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown