BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIZAI

    MDR report key: 20692419 · Received November 15, 2024

    Report

    Report Number
    3009500972-2024-00012
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 14, 2024
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    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

    A3B: GENDER: N/A. D2: PRODUCT CODE: DQO, KRA. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: REQUESTED, UNKNOWN. 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 RESULTS REVEALED THAT ONLY THE ZIZAI (HEREAFTER REFERRED TO AS THE INVOLVED DEVICE) ITSELF WAS RETURNED. THE FOLLOWING FINDINGS WERE OBSERVED IN THE APPEARANCE OF THE INVOLVED DEVICE: FLATNESS OF THE DISTAL PART, CRUSHED PARTS AT 28.0 CM FROM THE DISTAL TIP, 24.5 CM, 23.3 CM, AND 22.1 CM FROM THE PROXIMAL END, DEFORMATIONS NEAR 17.1 CM AND 32.2 CM FROM THE DISTAL TIP, AND ELONGATION OF THE CATHETER TOWARD A POINT OF 32.2 CM FROM THE DISTAL TIP. THE INNER AND OUTER DIAMETERS OF THE DEVICE INVOLVED WERE MEASURED TO INSPECT THE FOLLOWING POSSIBILITIES. THE TOTAL LENGTH WAS MEASURED TO CHECK FOR ELONGATION THAT HAD OCCURRED IN THE INVOLVED DEVICE, AND THE INNER AND OUTER DIAMETERS WERE MEASURED TO CHECK FOR ABNORMALITIES THAT MAY CAUSE TUBE DEFORMATIONS IN THE CATHETER, SUCH AS THE THINNESS OF RESIN. AS A RESULT, THE TOTAL LENGTH OF THE DEVICE INVOLVED WAS LONGER THAN OUR STANDARD VALUE, INDICATING THAT THE CATHETER WAS STRETCHED. THE OUTER DIAMETERS OF THE CRUSHED SECTIONS AT THE DISTAL PART AND 28.0 CM FROM THE DISTAL TIP OF THE INVOLVED DEVICE WERE OUTSIDE OUR STANDARD VALUES DUE TO FLATNESS AND CRUSHING. ONLY THE LONG DIAMETERS OF THE OUTER DIAMETERS OF THE CRUSHED PARTS AT 24.5 CM AND 22.1 CM FROM THE PROXIMAL END WERE OUTSIDE OUR STANDARD VALUES, WHILE THE OUTER DIAMETER OF THE CRUSHED PART AT 23.3 CM FROM THE PROXIMAL END WAS WITHIN OUR STANDARD VALUE. ADDITIONALLY, THE INNER AND OUTER DIAMETERS OF THE PROXIMAL PART OF THE INVOLVED DEVICE WERE WITHIN OUR STANDARD VALUES, AND NO ABNORMALITIES WERE FOUND. THE INNER DIAMETER OF THE DISTAL SIDE COULD NOT BE MEASURED AS THE PIN GAUGE COULD NOT PASS THROUGH DUE TO FLATTENING. INSPECTION OF MANUFACTURING RECORDS REVEALED THAT VISUAL INSPECTIONS, DIMENSION MEASUREMENTS, AND OTHER CHECKS ARE PERFORMED BY SAMPLING EACH PRODUCTION LOT. ADDITIONALLY, VISUAL INSPECTIONS ARE CONDUCTED ON ALL ZIZAI DEVICES BEFORE THE HOLDER ASSEMBLY IN THE MANUFACTURING PROCESS. UPON REVIEWING THE DEVICE HISTORY RECORDS FOR LOT 240100020, NO ABNORMALITIES WERE FOUND IN THE RESULTS OF EACH INSPECTION. THERE WERE NO ABNORMALITIES THAT COULD CAUSE DEFORMATION IN THE CATHETER. THE FOLLOWING FINDINGS WERE OBSERVED IN THE APPEARANCE OF THE INVOLVED DEVICE: FLATNESS OF THE DISTAL PART, CRUSHING PARTS AT 28.0 CM FROM THE DISTAL TIP, 24.5 CM, 23.3 CM, AND 22.1 CM FROM THE PROXIMAL END, DEFORMATIONS NEAR 17.1 CM AND 32.2 CM FROM THE DISTAL TIP, AND ELONGATION OF THE CATHETER TOWARD A POINT OF 32.2 CM FROM THE DISTAL TIP. AS A RESULT OF DIMENSION MEASUREMENT, THE OUTER DIAMETERS OF THE CRUSHED SECTIONS AT THE DISTAL PART AND 28.0 CM FROM THE DISTAL TIP OF THE INVOLVED DEVICE WERE OUTSIDE OUR STANDARD VALUES DUE TO FLATNESS AND CRUSHING. ONLY THE LONG DIAMETERS OF THE OUTER DIAMETERS OF THE CRUSHED PARTS AT 24.5 CM AND 22.1 CM FROM THE PROXIMAL END WERE OUTSIDE OUR STANDARD VALUES, WHILE THE OUTER DIAMETER OF THE CRUSHED PART AT 23.3 CM FROM THE PROXIMAL END WAS WITHIN OUR STANDARD VALUE. THE INNER AND OUTER DIAMETERS OF THE PROXIMAL PART OF THE DEVICE INVOLVED WERE WITHIN OUR STANDARD VALUES, AND NO ABNORMALITIES WERE FOUND. THE INNER DIAMETER OF THE DISTAL SIDE COULD NOT BE MEASURED AS THE PIN GAUGE COULD NOT PASS THROUGH DUE TO FLATTENING. UPON REVIEWING THE DEVICE HISTORY RECORDS, NO ABNORMALITIES THAT COULD CAUSE CATHETER DEFORMATIONS SUCH AS KINKS, CRUSHING, FLATNESS, OR ELONGATION WERE OBSERVED. FROM THE ABOVE RESULTS, IT WAS CONSIDERED THAT THE DEFORMATION, SUCH AS ELONGATION OR CRUSHING OF THE CATHETER, THAT OCCURRED IN THE INVOLVED DEVICE MAY HAVE OCCURRED DURING USE AFTER SHIPMENT FROM THE COMPANY.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PRODUCT WAS PASSED THROUGH A NARROWED, CALCIFIED BLOOD VESSEL. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED, CAUSING THE CATHETER TO STRETCH. DESPITE THE RESISTANCE, THE PRODUCT WAS EVENTUALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187580 ZIZAI MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 240100020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown