BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE GT

    MDR report key: 24713582 · Received March 30, 2026

    Report

    Report Number
    9681834-2026-00054
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 27, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI NO. N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: LEAD NURSE. G4: 510(K) NUMBER: K955801, K170417. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. 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: DURING USE ON THE PATIENT, THE END OF THE GLIDEWIRE DETACHED. A SNARE WAS USED FOR RETRIEVAL, AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778898 GLIDEWIRE GT WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RG*GW1618FM 250602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SNARE (MANUFACTURE: UNKNOWN)