BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGREAT LAMBDA

    MDR report key: 25060086 · Received May 1, 2026

    Report

    Report Number
    3009500972-2026-00009
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 1, 2026
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . D2B: PROCODE: DQO, KRA . E3: OCCUPATION: OTHER DOCTOR G4: 510K: N/A. 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. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER), REGISTRATION NO. (B)(4), IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER), REGISTRATION NO. 3009500972.

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: A PHYSICIAN REPORTED THAT DURING AN ENDOLEAK EMBOLIZATION PROCEDURE PERFORMED THE PREVIOUS WEEK, A THERAPEUTIC AGENT (ONYX) WAS USED. DURING INJECTION, THE PROGREAT LAMBDA MICROCATHETER SPLIT. AS A RESULT, NON-TARGET EMBOLIZATION OCCURRED. NO BLOOD LOSS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623539 PROGREAT LAMBDA MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1