BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 10406235 · Received August 14, 2020

    Report

    Report Number
    3002808904-2020-00016
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 29, 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. IT WAS CONFIRMED THAT THE BALLOON WAS 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: THE BALLOON MAY HAVE DAMAGED BY THE ANASTOMOTIC SITE OF AVF AND SHOULD HAVE BEEN RUPTURED WHEN THE BALLOON WAS INFLATED. WHILE REMOVING IT FROM THE PATIENT, THE BULKY PORTION OF THE RUPTURED BALLOON WAS CAUGHT ON THE ANASTOMOTIC SITE AND COULD NOT BE PULLED BACK ANY MORE. FURTHER ATTEMPTS TO FORCIBLY PULL BACK THE DEVICE RESULTED IN BREAKAGE OF THE BALLOON AND THE TIP, AND THE BROKEN PIECES REMAINED IN THE PATIENT'S BLOOD VESSEL.

    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." THE BALLOON OF THIS PRODUCT RUPTURED DURING TREATMENT AT THE ANASTOMOTIC SITE OF AVF. WHEN THE DOCTOR PULLED IT OUT, THE BALLOON HAS BROKEN. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON ON SAME DAY, AND THE BROKEN BALLOON WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875857 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SP109290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention