BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 23230594 · Received October 6, 2025

    Report

    Report Number
    9681834-2025-00175
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 6, 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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. 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. G4: 510(K) NUMBER: K923607, K926214. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. ACTUAL DEVICE UPON RECEIPT. - FRACTURED PIECE: APPROXIMATELY 31MM. - GUIDEWIRE MAIN BODY: APPROXIMATELY 1470MM. MICROSCOPIC INSPECTION. [FRACTURED PIECE]. - THE WIRE HAD BEEN EXPOSED AT THE FRACTURED SECTION. - THE OUTER LAYER AT THE FRACTURED SECTION HAD BEEN ELONGATED AND A TORN SHAPE WAS FOUND. - NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. [GUIDEWIRE MAIN BODY] - NO EXPOSURE OF THE WIRE WAS FOUND IN THE FRACTURED SECTION. - THE OUTER LAYER AT THE FRACTURED SECTION HAD BEEN ELONGATED AND A TORN SHAPE WAS FOUND. - NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. ELECTRON MICROSCOPIC INSPECTION OF THE WIRE. [FRACTURED PIECE]. - THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION HAD BEEN CURVED AND TAPERED. - DIMPLE PATTERNS (HOLE-SHAPED PATTERNS) WERE FOUND ON THE TOP SURFACE OF WIRE AT THE FRACTURED SECTION. CONFIRMATION OF DIMENSIONS. - OUTER DIAMETER AT THE NORMAL SECTIONS MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. CONFIRMATION OF THE MISSING LENGTH. - FRACTURED PIECE: APPROXIMATELY 31MM. - GUIDEWIRE MAIN BODY: APPROXIMATELY 1470MM. - TOTAL LENGTH: APPROXIMATELY 1501MM. SINCE THE LENGTH OF CURRENT PRODUCT IS APPROXIMATELY 1501MM, IT WAS LIKELY THAT THERE WAS NO MISSING LENGTH IN THE ACTUAL DEVICE. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER - NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. - NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST. SIMULATION TEST. PULLING FORCE WAS APPLIED TO THE SAMPLE IN THE LOOPED STATE AND FRACTURED IT. - THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION HAD BEEN CURVED AND TAPERED. - DIMPLE 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 THE GUIDEWIRE LOOPED DUE TO THE PUSH AND PULL OPERATION WHILE THE DISTAL END WAS TRAPPED. WHEN THE DEVICE WAS SUBSEQUENTLY REMOVED, PULLING FORCE WAS APPLIED, CAUSING THE WIRE AND OUTER LAYER TO FRACTURE. COMPARED TO THE CURRENT PRODUCT, IT WAS LIKELY THAT THERE WAS NO MISSING LENGTH IN THE ACTUAL DEVICE. RELEVANT IFU REFERENCE: "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. 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." (B)(4) (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: A UROLOGIST FROM THE HOSPITAL TREATED THE PATIENT'S STENOTIC LESION IN THE LEFT SUBCLAVIAN VEIN USING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THE LEFT BRACHIAL VEIN (ELBOW) WAS PUNCTURED, AND THE INVOLVED DEVICE WAS INSERTED TO ADVANCE. IMMEDIATELY AFTERWARDS, THE DISTAL END OF DEVICE BECAME LOST WITHIN THE BLOOD VESSEL AND COULD NO LONGER BE ADVANCED. THE DEVICE WAS THEN PUSHED AND PULLED SEVERAL TIMES UNTIL IT WAS REMOVED FROM THE PATIENT'S BODY. THEN, IT WAS NOTICED THAT THE DISTAL END OF DEVICE WAS MISSING AND HAD FRACTURED. THE TREATMENT WAS TEMPORARILY DISCONTINUED. THE PATIENT WAS IMMEDIATELY TRANSPORTED TO THE DEPARTMENT OF CARDIOLOGY AT (B)(6) HOSPITAL. A DOCTOR FROM THE UNIVERSITY APPROACHED THE RIGHT FEMORAL VEIN IN THE GROIN AND REMOVED THE DISTAL END OF DEVICE USING A SNARE CATHETER. THE PATIENT EXPERIENCED NO ANOMALY OR PROBLEM FROM THE START OF THE TREATMENT TO THE COMPLETION OF THE FRACTURED PIECE REMOVAL PROCEDURE. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746202 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA32153 250319YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention