BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIMINATE PLUS

    MDR report key: 23335460 · Received October 20, 2025

    Report

    Report Number
    3009500972-2025-00018
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 20, 2025
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETE INVESTIGATION RESULTS. USING THE DEVICE, THROMBUS ASPIRATION WAS PERFORMED. AFTER ASPIRATING THE THROMBUS THREE TIMES, WHEN ATTEMPTING TO REMOVE THE DEVICE, THE GUIDEWIRE BECAME STUCK IN THE DEVICE AND COULD NOT BE WITHDRAWN. APPEARANCE: THE CATHETER (HEREINAFTER REFERRED TO AS THE ACTUAL PRODUCT) AND STYLET WERE RETURNED FOR THE ELIMINATE PRODUCT. WHEN THE ACTUAL PRODUCT WAS OBSERVED, TEARING OF THE GW LUMEN WAS OBSERVED IN THE RANGE OF 4.8 CM TO 8.3 CM FROM THE TIP. NO ABNORMALITY SUCH AS FOLDING OR CRUSHING WAS FOUND AT THE TIP OF THE PRODUCT. REPRODUCIBILITY TEST: WE ATTEMPTED TO REPRODUCE THE TEARING OF THE GW LUMEN THAT OCCURRED IN THE ACTUAL PRODUCT BY USING AN ELIMINATE PRODUCTION FLOW PRODUCT AND PTCA TRAINER. METHOD: 1: SET A GUIDE WIRE OF THE APPROPRIATE SIZE INTO THE ELIMINATE PRODUCTION FLOW PRODUCT, INSERT IT INTO A PTCA TRAINER EQUIPPED WITH A GUIDING CATHETER OF THE APPROPRIATE SIZE. 2: MANIPULATE THE GUIDE WIRE TO FORM A LOOP WITH THE COMBINATION GUIDE WIRE. 3: IN THAT STATE, PERFORM THE REMOVAL OPERATION FOR THE ELIMINATE PRODUCTION FLOW PRODUCT. RESULTS: UPON OBSERVING THE EXIT PORT OF THE ELIMINATE PRODUCTION FLOW PRODUCT, A TEAR CLOSELY RESEMBLING THE ACTUAL PRODUCT WAS IDENTIFIED. BASED ON THE ABOVE RESULTS, IT WAS INFERRED THAT THE TEAR OF THE EXIT PORT IN THE ACTUAL PRODUCT WAS CAUSED BY THE FACT THAT THE COMBINATION GUIDE WIRE USED AT THE EXIT PORT OF THE ACTUAL PRODUCT BECAME DEFLECTED AND WAS REMOVED IN THAT STATE. THE GUIDE WIRE WAS DEFLECTED AT THE GUIDING TIP, CAUSING RESISTANCE. PULLING THE CATHETER WHILE IT IS STUCK AND DEFLECTED CAUSED THE GUIDE WIRE TO BREAK AND RESULTED IN DAMAGE TO THE EXIT PORT. OUR COMPANY CONDUCTS DIMENSION MEASUREMENTS AND OTHER INSPECTIONS ON SAMPLES TAKEN FROM EACH RAW MATERIAL LOT AND MANUFACTURING LOT OF TUBES FOR THE PRODUCT ELIMINATE. ADDITIONALLY, WE PERFORM A 100% VISUAL INSPECTION PRIOR TO ASSEMBLY INTO THE HOLDER. UPON REVIEWING THE MANUFACTURING RECORDS FOR THE ACTUAL PRODUCT LOT "240301110," NO ABNORMALITIES WERE FOUND IN THE INSPECTION RESULTS, AND NO ABNORMALITIES WERE IDENTIFIED THAT COULD POTENTIALLY CAUSE TEARING TO THE GW LUMEN INCLUDING ISSUES WITH THE INNER AND OUTER DIAMETERS. WHEN THE APPEARANCE OF THE ACTUAL PRODUCT WAS CHECKED, TEARING OF THE GW LUMEN WAS OBSERVED IN THE RANGE OF 4.8 CM TO 8.3 CM FROM THE TIP. DURING THE REPRODUCTION TEST, WHEN THE GUIDE WIRE WAS IN A LOOPED STATE AND THE REMOVAL OPERATION OF THE ELIMINATE PRODUCTION FLOW PRODUCT WAS PERFORMED, A TEAR OCCURRED IN THE GW LUMEN, IN THE SAME WAY AS THE ACTUAL PRODUCT. THE INSPECTION OF MANUFACTURING RECORDS REVEALED NO ABNORMALITIES THAT COULD POTENTIALLY CAUSE RESISTANCE IN THE GUIDE WIRE OR TEARING OF THE GW LUMEN. BASED ON THE ABOVE RESULTS, IT IS INFERRED THAT THE GW LUMEN TEARING AND WITHDRAWAL RESISTANCE OBSERVED IN THE ACTUAL PRODUCT WAS CAUSED BY THE REMOVAL OPERATION BEING PERFORMED WHILE THE WIRE WAS STUCK DUE DEFLECTION OF THE COMBINATION GUIDE WIRE AT EXIT PORT SECTION.

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: REQUESTED, NOT PROVIDED. 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 MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. DURING USE OF THE DEVICE, THROMBUS ASPIRATION WAS PERFORMED. AFTER ASPIRATING THE THROMBUS THREE TIMES AND ATTEMPTING TO REMOVE THE DEVICE, THE GUIDEWIRE BECAME STUCK AND COULD NOT BE WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2860267 ELIMINATE PLUS ASPIRATION CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. N/A 240301110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability