BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT LAMBDA

    MDR report key: 24090313 · Received January 15, 2026

    Report

    Report Number
    3009500972-2025-00026
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 15, 2026
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    UDI-DI
    04987350740984
    PMA / PMN Number
    K211078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROCODE: DQO, KRA. 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. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER), REGISTRATION NO. (B)(4), IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER), REGISTRATION NO. 3009500972.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9 AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. WE INVESTIGATED SIMILAR COMPLAINTS THAT HAD OCCURRED IN THE PAST. AS A RESULT, THERE HAD BEEN NO SIMILAR COMPLAINTS ABOUT THE PRODUCTION LOT 250203090 IN THE PAST. HOWEVER, WE COULD NOT IDENTIFY THE OCCURRENCE CAUSE OF THE FOLLOWING REASONS. THE INVOLVED DEVICE WAS NOT RETURNED, AND WE COULDN'T PERFORM THE DETAILED INVESTIGATION. IT OCCURRED WITH NORMAL USAGE. DETAILS OF THE OCCURRENCE SITUATION WERE UNKNOWN. THERE HAVE BEEN NO PRIOR SIMILAR COMPLAINTS WITHIN THE SAME LOT, AND NO ABNORMALITIES WERE IDENTIFIED THAT WOULD INDICATE A POTENTIAL RISK OF PENETRATION DUE TO THE USE OF A GUIDEWIRE. TERUMO MEDICAL CORPORATION (TMC) (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 MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE FIRST COIL BECAME STUCK, SO THEY TOOK THE MICRO OUT AND PUT IT BACK. A 2MM COIL THEN WORKED. ON THE THIRD COIL ATTEMPT, IT BECAME STUCK AGAIN. WHILE PUSHING A RUNTHROUGH WIRE, THE WIRE PERFORATED THE CATHETER. THEY WERE ABLE TO TAKE IT OUT BEFORE THE DISTAL SEGMENT BROKE OFF. THE PROCEDURE PERFORMED WAS AN HAE PROCEDURE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99961 PROGREAT LAMBDA MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. CC*M1916SN 250203090 04987350740984

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown