BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE ADVANTAGE

    MDR report key: 22965068 · Received September 4, 2025

    Report

    Report Number
    9681834-2025-00168
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 9, 2025
    Report Date
    September 4, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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: OVER 120KGS. 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. E1: PHONE NUMBER: UNKNOWN. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. G4: 510(K) NUMBER: K122590, K163004. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. 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. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL DEVICE COULD NOT BE INVESTIGATED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "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." "DO NOT APPLY REPETITIVE BENDING FORCE TO ONE SPECIFIC POINT OF THE DEVICE AS THIS MAY CAUSE DAMAGE TO THIS DEVICE." TERUMO MEDICAL CORPORATION (TMC) (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 GLIDEWIRE ADVANTAGE TIP BROKE OFF IN THE PATIENT. AT THE BEGINNING OF THE PROCEDURE THE VESSEL WAS HIGHLY CALCIFIED BELOW PUNCTURE SITE. THE DOCTOR ATTEMPTED TO ADVANCE THE WIRE; HOWEVER, THE WIRE GOT STUCK AFTER IT MADE A LOOP IN THE CALCIUM. THE WIRE WAS PULLED WITH FORCE THROUGH THE BRITE TIP SHEATH. THERE WAS NO VESSEL RUPTURE, ONLY THE +- 9CM HYDROPHILIC TIP PART THAT BROKE OFF. THE PATIENT WAS GOING FOR BYPASS FEMPOP SURGERY AS THE WIRE IS IN AN OCCLUDED AREA AND NOT MOVING AT ALL. THE PATIENT NEEDED ADDITIONAL INTERVENTION TO REMOVE THE BROKEN PART. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095352 GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*CA35265CM 241209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O 6FR BRITE TIP INTRODUCER