BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 24868659 · Received April 14, 2026

    Report

    Report Number
    3002808904-2026-00006
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 14, 2026
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED IN A BROKEN CONDITION. WE CONFIRMED THAT THE PRODUCT HAD BROKEN AT THE INNER SHAFT SECTION, APPROXIMATELY 4.5 MM FROM THE TIP, AND THE BALLOON SECTION, APPROXIMATELY 21 MM FROM THE TIP, AND THAT THE INNER SHAFT HAD BEEN STRETCHED. BY JOINING THE TIP-SIDE AND HANDLE-SIDE FRAGMENTS, WE CONFIRMED THAT THE BALLOON LENGTH WAS APPROXIMATELY 38 MM. PROBABLE CAUSE(S) AND OUR COMMENT: WE HAVE DETERMINED THAT THIS WAS AN INCIDENT CAUSED BY IMPROPER USE, IN WHICH THE BALLOON BECAME CAUGHT ON THE SHEATH OR OTHER COMPONENTS DURING REMOVAL, AND PULLING IT TOWARD THE OPERATOR'S HAND WHILE IN THAT STATE RESULTED IN THE RUPTURE OF THE INNER SHAFT AND THE BALLOON.

    Description of Event or Problem · 0

    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 IT IS SIMILAR DEVICE AS " CROSSTELLA OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER, 0.018" GUIDEWIRE COMPATIBLE) APPROVED IN US UNDER 510(K)# K160004. AFTER DEFLATION, THE TIP BROKE OFF WHILE THE DEVICE WAS BEING REMOVED FROM THE AFFECTED AREA, LEAVING A FRAGMENT INSIDE THE BODY. A SURGICAL INCISION WAS MADE, AND THE DEVICE WAS RETRIEVED UNDER DIRECT VISUALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931607 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SW115257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention