BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE ADVANTAGE

    MDR report key: 23003723 · Received September 9, 2025

    Report

    Report Number
    9681834-2025-00166
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 9, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AT THIS PRODUCT CODE 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: K122590, K163004. VISUAL AND MICROSCOPIC INSPECTIONS: THE ACTUAL DEVICE UPON RECEIPT WAS ONLY A GLIDEWIRE ADVANTAGE. THE OUTER LAYER AT THE DISTAL END HAD BEEN FRACTURED. THE OUTER LAYER AT THE DISTAL END HAD BEEN ELONGATED APPROXIMATELY 46MM. NO ANOMALY WAS FOUND IN OTHER SECTIONS. MICROSCOPIC INSPECTION OF THE WIRE: THE OUTER LAYER AT THE DISTAL END OF ACTUAL DEVICE WAS REMOVED TO CONFIRM THE CONDITION OF WIRE. THE DISTAL END OF THE WIRE AND GOLD COIL WERE FOUND. THE DISTAL END OF GOLD COIL HAD BEEN BENT. IT WAS LIKELY TO HAVE BEEN LOOPED. SINCE THE DISTAL END OF WIRE WAS NOT EXPOSED, AND THE CROSS SECTION AT THE DISTAL END COULD NOT BE CONFIRMED, THE DIMENSIONS OF WIRE WERE CONFIRMED. THEY WERE CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. THEREFORE, IT WAS LIKELY THAT THE WIRE WAS NOT FRACTURED, BUT THE OUTER LAYER WAS ELONGATED AND FRACTURED. CONFIRMATION OF DIMENSION: THE OUTER DIAMETER MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST. BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF THIS CASE, THE FOLLOWING MECHANISM WAS INFERRED. THE ACTUAL DEVICE CAME INTO CONTACT WITH SOME HARD OBJECT (E.G., CALCIFIED LESION), ITS DISTAL END WAS LOOPED, AND THE OUTER LAYER GOT CAUGHT. THE PROCEDURE WAS CONTINUED WHILE IT WAS STILL CAUGHT, CAUSING THE OUTER LAYER TO ELONGATE AND FRACTURE. HOWEVER, SINCE THE DETAILS OF PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OUTER LAYER GETTING CAUGHT, AND THE CAUSE OF OCCURRENCE COULD NOT BE IDENTIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "THE IFU OF THIS PRODUCT INCLUDES THE FOLLOWING WARNING. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THIS DEVICE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. IF THE SITUATION IS NOT SOLVED, EXERCISE CAUTION WHEN REMOVING THE DEVICE AND/OR OTHER COMPONENTS AS A UNIT, AND EXCHANGE THE DEVICE FOR A NEW ONE TO COMPLETE THE PROCEDURE. CONTINUING TO MANIPULATE OR ROTATE THIS DEVICE 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." (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 REPORTED INFORMATION. THE PROCEDURE WAS A LEFT 4TH PAOD VIA RIGHT TRANSFEMORAL ACCESS, RETROGRADE PUNCTURE WITH SHEATH WIRE, CROSSOVER MANEUVER. A 6 FRENCH SHEATH WAS INSERTED, INSERTION OF A GWA 18 WIRE, RECANALIZATION OF THE POPLITEAL ARTERY IN COMBINATION WITH A 35 MM 150 CM ANGLED NC. THE GWA WAS IN A LOOP, AND THE COATING TORE DURING RETRACTION. THE NC WAS NOT REMOVED. THE INTERVENTION WAS SUCCESSFULLY COMPLETED, AND A SUPERA 5/150 WAS IMPLANTED. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT'S BODY. THE INTERVENTION WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465921 GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18301CM 250401Y

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other 35 MM 150 CM ANGLED NC (NAVICROSS).| SUPERA PERIPHERAL STENT 5/150.