BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 10095226 · Received May 28, 2020

    Report

    Report Number
    3002808904-2020-00010
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 1, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED AS A SINGLE CATHETER. IT WAS CONFIRMED THAT THE BALLOON PART ABOUT 4 CM FROM THE TIP OF THE PRODUCT WAS CONSTRICTED. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED. THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE SHAFT-PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. PROBABLE CAUSE(S) AND OUR COMMENT: WHEN THE ARTICLE WAS INSERTED, THE TIP OF THE BALLOON WAS FIXED AT THE LESION OR THE LIKE, AND THE ARTICLE WAS TWISTED IN THAT STATE, SO THAT THE CENTRAL PORTION OF THE BALLOON WAS TWISTED. THE BALLOON WAS INFLATED, BUT THE BALLOON AT THE TIP PORTION COULD NOT BE DEFLATED FROM THE TWISTED PORTION.

    Description of Event or Problem · 1

    SHIRANUI EX IS A RAPID-EXCHANGE TYPE SEMI-COMPLIANT PTA BALLOON CATHETER COMPATIBLE WITH 0.018 INCH GUIDEWIRE. SHIRANUI EX HAS NO APPROVAL IN USA. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "METACROSS OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER, 0.035" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K152080." CROSSTELLA OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K160004."." CROSSTELLA RX" (RX TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)#K152873."" CROSPERIO OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.014" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K160013." AFTER EXPANDING WITH A CALCIFIED LESION, THE BALLOON WAS UNABLE TO DEFLATE. THE PRODUCT WAS OPERATED SEVERAL TIMES WITH AN INFLATION DEVICE, BUT DEFLATION COULD NOT BE PERFORMED, SO THE BALLOON OF THE PRODUCT WAS DIRECTLY PUNCTURED WITH A PUNCTURE NEEDLE, AND THE PRODUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560313 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SP079173

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention