BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE ADVANTAGE

    MDR report key: 23020188 · Received September 10, 2025

    Report

    Report Number
    9681834-2025-00164
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 10, 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 HAD BEEN FLARED TOWARD THE DISTAL SIDE AT APPROXIMATELY 22MM - 31MM FROM THE DISTAL END. THE OUTER LAYER HAD BEEN PEELED OFF AT APPROXIMATELY 31MM - 40MM FROM THE DISTAL END. THE OUTER LAYER HAD BEEN ELONGATED AND SCRATCHED AT APPROXIMATELY 41MM FROM THE DISTAL END. NO ANOMALY WAS FOUND IN OTHER SECTIONS. CONFIRMATION OF DIMENSION: IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. CONFIRMATION OF THE MISSING LENGTH: FLARE OF THE OUTER LAYER: APPROXIMATELY 9MM. EXPOSURE OF THE WIRE: APPROXIMATELY 9MM. SINCE THE LENGTH OF THE FLARED OUTER LAYER AND THE EXPOSED WIRE MATCHED, IT WAS INFERRED THAT THERE WAS NO MISSING IN THE OUTER LAYER. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER ALTHOUGH ONE SIMILAR REPORT WAS FOUND IN THE PAST, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS. SIMULATION TEST: WITH THE TEST SAMPLE ABRADED, IT WAS DRAWN INTO THE CATHETER. AS A RESULT, THE ABRASION GOT CAUGHT ON THE CATHETER AND THE OUTER LAYER WAS PEELED OFF. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS AND DIMENSION OF THE ACTUAL DEVICE. AS A POSSIBLE CAUSE OF THIS CASE, THE FOLLOWING MECHANISM WAS INFERRED. THE ACTUAL DEVICE CAME INTO CONTACT WITH SOME HARD OBJECT AND WAS SCRATCHED WHEN IT WAS FORMED INTO A LOOP. WHEN THE ACTUAL DEVICE WAS MOVED BACKWARD WITH THE SCRATCH CAUGHT ON THE COMBINED DEVICE, THE OUTER LAYER PEELED OFF TOWARD THE DISTAL DIRECTION. HOWEVER, SINCE THE DETAILS OF PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY WHAT THE HARD OBJECT WAS. RELEVANT INSTRUCTIONS FOR USE (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

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION. PERIPHERAL ARTERY DISEASE (PAD) ON THE RIGHT. LEFT TRANSFEMORAL ACCESS, RETROGRADE PUNCTURE, CROSSOVER MANEUVER AND INSERTION OF A 6F SHEATH, INSERTION OF A GLIDEWIRE ADVANTAGE (GWA) 18 WIRE, FAILED ATTEMPT TO RECANALIZE THE RIGHT ATA IN COMBINATION WITH AN NC 18 150 CM ANGLED. THE GWA WAS IN A LOOP, AND THE COATING TORE DURING RETRACTION. THE NC WAS NOT REMOVED. THE PEELED COATING MY HAVE REMAINED IN THE PATIENT BODY. THE INTERVENTION WAS ABORTED UNSUCCESSFULLY, AND THE PUNCTURE SITE WAS CLOSED WITH AN ANGIO-SEAL. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499745 GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18301CM 250401Y

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female Other ANGIO-SEAL.| NAVICROSS 0.018" 150CM ANGLED.