BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT LAMBDA

    MDR report key: 24307444 · Received February 10, 2026

    Report

    Report Number
    3009500972-2026-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 10, 2026
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . D2B: PROCODE: DQO, KRA. . E3: OCCUPATION: OTHER DOCTOR G4: 510K: N/A. SINCE THE INVOLVED DEVICE WAS NOT RETURNED, IT WAS IMPOSSIBLE TO ANALYZE. AT OUR COMPANY, FOR PROGREAT LAMBDA, APPEARANCE INSPECTIONS AND DIMENSIONAL MEASUREMENTS ARE PERFORMED ON A SAMPLING BASIS FOR EACH MANUFACTURING LOT. ADDITIONALLY, DURING THE MANUFACTURING PROCESS, A 100% VISUAL INSPECTION IS CONDUCTED PRIOR TO ASSEMBLY ONTO THE HOLDER. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 241100970 REVEALED NO ABNORMALITIES THAT COULD CAUSE ISSUES SUCH AS POOR CATHETER TRACKABILITY OR PERFORATION. WE CONDUCTED AN INVESTIGATION INTO PAST COMPLAINTS OF A SIMILAR NATURE. AS A RESULT, NO SIMILAR COMPLAINTS WERE FOUND FOR LOT 241100970. SINCE THE INVOLVED DEVICE WAS NOT RETURNED AND NO ABNORMALITIES WERE FOUND IN THE INVESTIGATION, WE COULD NOT IDENTIFY THE CAUSE OF THE POOR CATHETER TRACKABILITY OR PERFORATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER), REGISTRATION NO. (B)(6), 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: AFTER FLUSHING THE MICROCATHETER, DURING THE INSERTION OF A 0.014" COMMAND STANDARD GUIDEWIRE, IT WAS OBSERVED THAT THE GUIDEWIRE WAS UNABLE TO ADVANCE BEYOND THE MIDPOINT OF THE MICROCATHETER. ADDITIONALLY, THE DISTAL SEGMENT OF THE MICROCATHETER EXHIBITED AN ABNORMAL CONSISTENCY, DESCRIBED AS SIMILAR TO CHEWING GUM. SUBSEQUENTLY, THE GUIDEWIRE WAS REMOVED AND THE MICROCATHETER WAS FLUSHED AGAIN. DURING THIS PROCESS, IT WAS OBSERVED THAT THE DISTAL PORTION OF THE MICROCATHETER SHOWED MULTIPLE MICRO-PERFORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287142 PROGREAT LAMBDA MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 241100970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown