BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIZAI

    MDR report key: 20061275 · Received August 26, 2024

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    Report

    Report Number
    3009500972-2024-00008
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 25, 2024
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: PRODUCT CODE: KRA (ZIZAI'S DEVICE FAMILY, PROGREAT IS REGISTERED WITH BOTH DQO AND KRA). D2: PRODUCT CODE NAME: CATHETER, CONTINUOUS FLUSH . 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. INVESTIGATION RESULT OBSERVATION DURING CLEANING ZIZAI (HEREINAFTER CALLED THE INVOLVED DEVICE) AND THE COMBINATION GUIDEWIRE WERE RETURNED TO TCSC. WHEN OBSERVING THE CONDITION OF THE INVOLVED DEVICE AT THE ARRIVAL, THE COMBINATION GUIDEWIRE WAS INSERTED INTO ZIZAI AND PROTRUDED ABOUT 95.5 CM FROM THE DISTAL TIP. TO CLEAN THE INVOLVED DEVICE, WHEN GRASPING THE DISTAL SIDE OF THE COMBINATION GUIDEWIRE AND ATTEMPTING TO REMOVE, IT COULD NOT BE REMOVED DUE TO RESISTANCE. FOR THIS REASON, THE DEVICE INVOLVED COULD NOT BE CLEANED NORMALLY. A VISUAL INSPECTION WAS CONDUCTED. WHEN OBSERVING THE APPEARANCE OF THE INVOLVED DEVICE, THE FOLLOWING FINDINGS WERE OBSERVED: THE OUTER LAYER OF THE DISTAL TIP PART OF THE INVOLVED DEVICE WAS SEPARATED, LEAVING A GOLD COIL MARKER. THE GOLD COIL IN THE MARKER PART OF THE INVOLVED DEVICE WAS DISTORTED AND CRUSHED. THE SHAFT WAS DEFORMED IN A BELLOWS SHAPE FOR ABOUT 1.0 CM TO 35.5 CM FROM THE DISTAL TIP. THE CATHETER WAS STRETCHED TO 15.7 CM FROM THE DISTAL TIP. A FOREIGN SUBSTANCE WAS STUCK IN THE LUMEN FOR ABOUT 71.7 CM TO 121.0 CM FROM THE DISTAL TIP. THERE WERE NO ABNORMALITIES OF APPEARANCE IN OTHER PARTS THAT COULD CAUSE THE COMBINATION GUIDEWIRE TO GET STUCK. INSPECTION OF MANUFACTURING RECORDS IN OUR COMPANY, WE PERFORM VISUAL INSPECTIONS, DIMENSION MEASUREMENTS, ETC. BY SAMPLING EACH PRODUCTION LOT. IN ADDITION, WE PERFORM VISUAL INSPECTIONS TOWARD ALL ZIZAI BEFORE THE HOLDER ASSEMBLY IN THE MANUFACTURING PROCESS. AS A RESULT OF REVIEWING DEVICE HISTORY RECORDS OF LOT 230904070, THERE WERE NO ABNORMALITIES IN THE RESULTS OF EACH INSPECTION. THERE WERE NO ABNORMALITIES THAT COULD CAUSE THE DEFORMATION OR ELONGATION IN THE CATHETER. THE INVOLVED DEVICE WAS RETURNED IN THE STATUS THAT THE COMBINATION GUIDEWIRE SET ON IT. TO CLEAN THE INVOLVED DEVICE, WHEN GRASPING THE DISTAL SIDE OF THE COMBINATION GUIDEWIRE AND ATTEMPTING TO REMOVE, IT COULD NOT BE REMOVED DUE TO RESISTANCE. FOR THIS REASON, THE DEVICE INVOLVED COULD NOT BE CLEANED NORMALLY. WHEN OBSERVING THE APPEARANCE OF THE INVOLVED DEVICE, THE DISTAL TIP OF THE INVOLVED DEVICE WAS FOUND TO BE SEPARATED, DAMAGE AROUND THE MARKER PART WITH NARROWING AND DISTURBANCE OF THE COIL, BELLOWS SHAPED DEFORMATION FROM THE DISTAL TIP OF ABOUT 1.0 CM TO 35.5 CM, AND ELONGATION OF THE CATHETER FOR ABOUT 15.7 CM FROM THE DISTAL TIP. IN ADDITION, A FOREIGN SUBSTANCE WAS STUCK IN THE LUMEN FOR ABOUT 71.7 CM TO 121.0 CM FROM THE DISTAL TIP. BASED ON THE OCCURRENCE SITUATION REPORTED, IT WAS PRESUMED THAT THE FOREIGN SUBSTANCE IN THE LUMEN OF THE INVOLVED DEVICE WAS COAGULATED BLOOD. IN OUR COMPANY, WE PERFORM VISUAL INSPECTIONS, DIMENSION MEASUREMENTS, ETC. BY SAMPLING EACH PRODUCTION LOT. IN ADDITION, WE PERFORM VISUAL INSPECTIONS TOWARD ALL ZIZAI BEFORE THE HOLDER ASSEMBLY IN THE MANUFACTURING PROCESS. AS A RESULT OF REVIEWING DEVICE HISTORY RECORDS, THERE WERE NO ABNORMALITIES THAT COULD CAUSE THE TIP SEPARATION, COIL DEFORMATION, OR CATHETER PERFORATION OR ELONGATION. FROM THIS, IT WAS CONSIDERED THAT THE CATHETER DAMAGE AND DEFORMATION OCCURRED IN THE INVOLVED DEVICE MAY HAVE BEEN CAUSED BY USE AFTER SHIPMENT FROM OUR COMPANY. NEXT, IT WAS PRESUMED THAT THE CATHETER ELONGATION THAT OCCURRED IN THE INVOLVED DEVICE MAY HAVE BEEN CAUSED BY THE CATHETER OPERATION IN A STUCK CONDITION. THE COMBINATION GUIDEWIRE PROTRUDED ABOUT 100 CM FROM THE DISTAL TIP FOR THIS REASON, IT WAS PRESUMED THAT THE COMBINATION GUIDEWIRE IS INSERTED ABOUT 80 CM FROM THE DISTAL TIP OF THE INVOLVED DEVICE. THE DEVICE INVOLVED WAS STUCK WITH A FOREIGN SUBSTANCE EXPECTED TO BE A THROMBUS, OVER A RANGE OF ABOUT 70 CM TO 120 CM FROM THE DISTAL TIP. FROM THIS, IT WAS CONSIDERED THAT THE COMBINATION GUIDEWIRE STUCK IN THE INVOLVED DEVICE MAY HAVE BEEN CAUSED BY THE FACT THAT THE PROXIMAL SIDE OF THE COMBINATION GUIDEWIRE STUCK WITH A THROMBUS IN THE LUMEN OF THE INVOLVED DEVICE. IN ADDITION, SINCE THE INVOLVED DEVICE WAS DEFORMED AND STRETCHED OVER A WIDE AREA, IT WAS CONSIDERED THAT THESE DEFORMATIONS AND ELONGATION MAY HAVE NARROWED THE LUMEN OF THE INVOLVED DEVICE AND CAUSED THE COMBINATION GUIDEWIRE TO GET STUCK. IT WAS PRESUMED THAT THE DISTAL TIP PART SEPARATED FROM THE INVOLVED DEVICE MAY HAVE REMAINED IN THE BODY, OR IN THE LUMEN OF THE GUIDING CATHETER.

    Description of Event or Problem · 0

    THE USER FACILITY STATED THAT WHEN THE PRODUCT WAS BEING INSERTED INTO A BLOOD VESSEL, THE GUIDEWIRE AND THE PRODUCT BECAME ENTANGLED IN THE VESSEL. ON (B)(6) 2024, THE MANUFACTURER RECEIVED IMAGES OF THE BROKEN SAMPLE. UPON REVIEWING THE IMAGES, IT WAS FOUND THE SAMPLE'S TIP BROKE OFF. SOME OF THE BROKEN PARTS MAY REMAIN IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231917 ZIZAI MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 230904070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other