BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT LAMBDA

    MDR report key: 24888522 · Received April 15, 2026

    Report

    Report Number
    3009500972-2026-00005
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 15, 2026
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROCODE: DQO, KRA. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: UNKNOWN. E3: OCCUPATION: OTHER DOCTOR. G4: 510K: N/A. THE ACTUAL DEVICE HAS BEEN 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. 2243441, 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: DURING THE WITHDRAWAL OF THE MICROCATHETER, THE MICROCATHETER BROKE. A PART OF IT REMAINED INSIDE THE ARTERY. THERE WAS NO IMPACT TO THE PATIENT, AS IT WAS LOCATED AT THE ENTRANCE OF THE EMBOLIZATION AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139018 PROGREAT LAMBDA MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 250403530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention