BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEWIRE ADVANTAGE

    MDR report key: 22609943 · Received July 25, 2025

    Report

    Report Number
    9681834-2025-00123
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    March 31, 2025
    Report Date
    July 25, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. E3: OCCUPATION: PHARMACIST RESIDENT. G4: 510(K): K122590, K163004. THE RETURNED DEVICE WAS THE ACTUAL DEVICE AND A COMPETITOR'S SUPPORT CATHETER (SEEKER) GETTING STUCK. VISUAL INSPECTION OF THE ACTUAL DEVICE BEFORE RELEASING THE STUCK. THE DISTAL END OF ACTUAL DEVICE HAD NOT BEEN EXPOSED FROM THE DISTAL END OF COMPETITOR'S SUPPORT CATHETER. DESPITE SOME RESISTANCE, IT WAS POSSIBLE TO RELEASE THE STUCK. VISUAL AND MICROSCOPIC INSPECTIONS OF THE ACTUAL DEVICE AFTER RELEASING THE STUCK. THERE WAS A KNOT AT THE DISTAL END. THERE WERE ABRASIONS NEAR THE KNOT. NO ANOMALY WAS FOUND IN OTHER SECTIONS. CONFIRMATION OF DIMENSIONS: OUTER DIAMETERS OF THE HYDROPHILIC COATING AND PTFE COATING MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. 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 COMPLAINT FILE. SIMULATION TEST [TEST METHOD]: A RADIFOCUS GLIDEWIRE ADVANTAGE WAS INSERTED INTO A FACTORY-RETAINED MICROCATHETER (NAVICROSS), AND PUSHING AND TORQUE FORCES WERE APPLIED TO THE SIMULATED STENOSIS PART. AS A RESULT, A LOOP WAS FORMED AT THE DISTAL END. THE SAME FORCES WERE THEN APPLIED CONTINUOUSLY. AS A RESULT, THE DISTAL SIDE ENDED UP PASSING THROUGH A LOOP. SUBSEQUENTLY, THE REMOVAL OPERATION WAS PERFORMED VIGOROUSLY. IT GOT CAUGHT ON THE MICROCATHETER. [TEST RESULT]: A KNOT WAS FORMED AT THE DISTAL END OF RADIFOCUS GLIDEWIRE ADVANTAGE. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND DIMENSIONS. FROM THE CONDITION OF ACTUAL DEVICE AND SIMULATION TEST RESULTS, AS A POSSIBLE CAUSE OF OCCURRENCE, THE FOLLOWING FACTORS WERE INFERRED. HOWEVER, SINCE THE DETAILS OF PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. A KNOT FORMED AT THE DISTAL END OF ACTUAL DEVICE DUE TO THE APPLICATION OF FORCES SIMILAR TO THAT IN THE SIMULATION TEST. IN THIS STATE, THE REMOVAL OPERATION OF ACTUAL DEVICE WAS CONTINUED, AND THE ACTUAL DEVICE WAS PULLED INTO THE COMPETITOR'S SUPPORT CATHETER. THE KNOT THEN GOT CAUGHT ON THE COMPETITOR'S SUPPORT CATHETER AND GOT STUCK. REGARDING THE CAUSE OF ABRASIONS, IT WAS INFERRED THAT THEY CAME INTO CONTACT WITH SOME HARD OBJECT. HOWEVER, SINCE DETAILS OF THE PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY WHAT THE HARD OBJECT WAS. RELEVANT IFU REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A FEMORAL RECANALIZATION PROCEDURE: BLOCKAGE OF THE VASCULAR GUIDE IN THE PROBE, REQUIRING REMOVAL OF THE DEVICES CLINICAL CONSEQUENCES IDENTIFIED: LOSS OF RECANALIZATION, LOSS OF TIME. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037740 GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*CA35185CM 240917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEEKER CROSSING SUPPORT CATHETER.