BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 10394856 · Received August 12, 2020

    Report

    Report Number
    3002808904-2020-00015
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 17, 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 CONCERNED DEVICE WAS RETURNED. IT WAS CONFIRMED THAT THE BALLOON WAS TWISTED AND BROKEN. 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 BALLOON CATHETER WAS INSERTED, THE TIP OF THE BALLOON WAS STUCK AT THE LESION OR THE LIKE, AND THE BALLOON CATHETER WAS TWISTED IN THAT STATE, SO THAT THE CENTRAL PORTION AND DISTAL OF THE BALLOON WAS TWISTED. AFTER THAT, THE BALLOON WAS INFLATED, BUT THE BALLOON COULD NOT BE DEFLATED FROM THE TWISTED PORTION OF DISTAL.

    Description of Event or Problem · 1

    SHIRANUI EX IS AN OVER THE WIRE 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 AT THE ANASTOMOSIS, THE BALLOON COULD NOT BE DEFLATED. THE PRODUCT COULD NOT BE DEFLATED, SO THE BALLOON OF THE PRODUCT WAS DIRECTLY PUNCTURED WITH A PUNCTURE NEEDLE FROM ABOVE THE SKIN, AND THE PRODUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859427 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SR040310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention