BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIMINATE PLUS

    MDR report key: 14148199 · Received April 19, 2022

    Report

    Report Number
    3009500972-2022-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 19, 2022
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE: DEVICE WAS NOT IMPLANTED, EXPLANT DATE: DEVICE WAS NOT EXPLANTED. ESTABLISHMENT NAME: (B)(6) CLINIC. (B)(4). ONLY THE CATHETER OF THE INVOLVED DEVICE WAS RETURNED TO TCSC. VISUAL INSPECTION WAS CONDUCTED. WHEN WE OBSERVED THE APPEARANCE, THE GW LUMEN HAD THE ABOUT 0.4 CM TEAR FROM THE EXIT PORT TOWARD THE DISTAL TIP. IT WAS PRESUMED THAT THE TEAR OF THE GW LUMEN OF THE INVOLVED DEVICE WAS CAUSED BY THE LOAD FROM THE INSIDE OF THE GW LUMEN AS THE RESIN STRETCHED OUTWARD FROM THE INSIDE. IN OTHER PARTS, THERE WAS NO ABNORMALITY OF APPEARANCE SUCH AS KINK OR CRUSHING. THE INVOLVED DEVICE REVEALED THAT THE GW LUMEN HAD THE ABOUT 0.4 CM TEAR FROM THE EXIT PORT TOWARD THE DISTAL TIP. THE DISTAL TIP OF THE INVOLVED DEVICE REVEALED THAT THERE WAS NO ABNORMALITY OF APPEARANCE SUCH AS KINK OR CRUSHING ON THE DISTAL PART. TEAR OF GW LUMEN (UPPER: FRONT / LOWER: SIDE) SHOWED THAT THE TEAR FROM THE EXIT PORT TOWARD THE DISTAL TIP. FOR THE TEAR OF THE GW LUMEN OF THE INVOLVED DEVICE, THE RESIN STRETCHED OUTWARD FROM THE INSIDE. WE CONDUCTED THE SIMULATION TEST OF THE TEAR OF GW LUMEN OF THE INVOLVED DEVICE USING THE ELIMINATE AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTCA) TRAINER. FIRST, SET THE COMPATIBLE SIZE GUIDE WIRE TO THE ELIMINATE AND INSERT IT INTO THE PTCA TRAINER WITH THE COMPATIBLE SIZE GUIDING CATHETER. SECOND, OPERATE THE GUIDE WIRE TO FORM A LOOP ON THE COMBINED GUIDE WIRE. THIRD, IN THAT STATE, PERFORM THE REMOVAL OPERATION OF ELIMINATE. AS A RESULT OF OBSERVING THE EXIT PORT OF THE ELIMINATE, A TEAR VERY SIMILAR TO THE INVOLVED DEVICE WAS FOUND. FROM THE ABOVE RESULTS, IT WAS PRESUMED THAT THE TEARING OF THE GW MAIN LUMEN THAT OCCURRED IN THE INVOLVED DEVICE WAS DUE TO THE LOOP OF THE COMBINED GUIDE WIRE NEAR THE EXIT PORT AND THE REMOVAL OPERATION IN THAT STATE. THE GUIDE WIRE LOOPS AT THE DISTAL PART OF THE GUIDING CATHETER, CAUSING RESISTANCE. PULLING THE CATHETER IN STUCK AND LOOP STATE BREAKS THE GUIDE WIRE AND DAMAGES THE EXIT PORT. AS A RESULT OF REVIEWING THE MANUFACTURING RECORD OF THE INVOLVED DEVICE'S MANUFACTURING LOT "210801360", THE DIMENSIONS OF THE INNER AND OUTER DIAMETERS, TENSILE STRENGTH, ELONGATION, ETC. MET OUR STANDARD VALUES. THE ABNORMALITY THAT LEADS TO PASSAGE RESISTANCE OF THE GUIDE WIRE AND TEARING OF THE EXIT PORT WAS NOT OBSERVED. TO CHECK THE FOLLOWING POSSIBILITIES, WE INSPECTED THE INNER AND OUTER DIAMETER DIMENSIONS OF THE INVOLVED DEVICE. INNER DIAMETER: POSSIBILITY OF ASPIRATION FAILURE SUCH AS STENOSIS OF THE MAIN LUMEN AS A RESULT, THE INNER DIAMETER OF THE MAIN LUMEN OF THE INVOLVED DEVICE WAS WITHIN OUR STANDARD VALUES, AND NO ABNORMALITY WAS FOUND. INNER DIAMETER OF MAIN LUMEN (INVOLVED DEVICE): STANDARD VALUE - 1.09MM*1 AND MEASURED VALUE - PIN GAUGE PASSED THROUGH. (1: THE PIN GAUGE SHOULD BE PASSED THROUGH WITHOUT RESISTANCE) AS A RESULT OF THE APPEARANCE OBSERVATION OF THE INVOLVED DEVICE, THE GW LUMEN HAD THE ABOUT 0.4 CM TEAR FROM THE EXIT PORT TOWARD THE DISTAL TIP. IT WAS PRESUMED THAT THE TEAR OF THE GW LUMEN OF THE INVOLVED DEVICE WAS CAUSED BY THE LOAD FROM THE INSIDE OF THE GW LUMEN AS THE RESIN STRETCHED OUTWARD FROM THE INSIDE. IN OTHER PARTS, THERE WAS NO ABNORMALITY OF APPEARANCE SUCH AS KINK OR CRUSHING. IN THE SIMULATION TEST, WHEN THE REMOVAL OPERATION OF THE ELIMINATE WITH THE GUIDE WIRE FORMING A LOOP WAS PERFORMED, THE TEAR FROM THE EXIT PORT TOWARD THE DISTAL TIP SIMILAR TO THE INVOLVED DEVICE WAS OCCURRED. FOR THE DIMENSION MEASUREMENT AND THE MANUFACTURING RECORD INSPECTION, NO ABNORMALITIES THAT COULD CAUSE THE ASPIRATION FAILURE OR TEARING OF THE GW LUMEN WERE FOUND. FROM THE ABOVE RESULTS, IT WAS PRESUMED THAT THE TEARING OF THE GW MAIN LUMEN THAT OCCURRED IN THE INVOLVED DEVICE WAS DUE TO THE LOOP OF THE COMBINED GUIDE WIRE NEAR THE EXIT PORT AND THE REMOVAL OPERATION IN THAT STATE. REGARDING THE ASPIRATION FAILURE THAT YOU NOTIFIED, THERE WERE NO ABNORMALITIES THAT COULD CAUSE THE ASPIRATION FAILURE, SUCH AS KINK, CRUSHING, AND ABNORMAL INNER DIAMETER. THEREFORE, IN THIS INVESTIGATION, WE COULD NOT IDENTIFY THE CAUSE OF THE ASPIRATION FAILURE THAT OCCURRED IN THE INVOLVED DEVICE. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE INVOLVED ELIMINATE + WAS USED TO ASPIRATE A THROMBOTIC LESION OF #3 BUT COULD NOT ASPIRATE WELL. WHEN THE DEVICE WAS REMOVED IT WAS CONFIRMED THAT THE SIDE OF THE OF THE CATHETER WAS TORN. THIS DEVICE WAS NOT USED, AND ANOTHER ELIMINATE DEVICE WAS ABLE TO AS ASPIRATE WITHOUT ANY PROBLEMS. THE PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705033 ELIMINATE PLUS ASPIRATION THROMBECTOMY CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. N/A 220302199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown