BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGREAT

    MDR report key: 25115986 · Received May 7, 2026

    Report

    Report Number
    9681834-2026-00099
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 7, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS 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: 510K: K033913. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE 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. A 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 RECEIVED THE FOLLOWING REPORTED INFORMATION: WHEN THE PRODUCT WAS USED, IT WAS FOUND URETHANE COATING OR HYDROPHILIC COATING OF THE GUIDEWIRE PEELED OFF. THE TIMING WHEN IT PEELED OFF WAS UNKNOWN. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192447 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PP27131 250702

    Patients

    Seq Age Sex Outcome Treatment
    1