BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE ADVANTAGE

    MDR report key: 22461965 · Received July 9, 2025

    Report

    Report Number
    9681834-2025-00126
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 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
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. G4: 510(K): K122590, K163004. THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. 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 FROM OTHER FACILITIES WAS FOUND IN THE PAST. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO IDENTIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "DO NOT USE THE GLIDEWIRE ADVANTAGE WITH DEVICE WHICH CONTAIN METAL PARTS SUCH AS ATHERECTOMY CATHETERS, LASER CATHETERS, OR METAL INTRODUCTION DEVICES AS THEY MAY CAUSE THE GLIDEWIRE ADVANTAGE PLASTIC COATING TO SHEAR AND/OR SEVER THE WIRE." 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 THE GUIDEWIRE BECAME FRAYED AT THE TIP WHEN IT WAS REMOVED FROM A RETROGRADE PUNCTURE AND RUBBED AGAINST THE BEVEL. THE URETHANE HAS PEELED OFF, AND THE PEELED PIECE MAY REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602077 GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18301CM 241031A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| O