BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 24218660 · Received January 29, 2026

    Report

    Report Number
    3002808904-2026-00001
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 10, 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 DEVICE WAS RETURNED IN A HOOP CONTAINER. IT WAS CONFIRMED THAT THE INNER TUBE OF THE DEVICE HAD ELONGATED, AND THAT THE TIP, BALLOON (APPROXIMATELY 8 MM LENGTH), AND ONE RING MARKER WERE MISSING. IT WAS ALSO CONFIRMED THAT THE INNER SHAFT OF THE PROXIMAL BALLOON WAS DEFORMED. ALSO, THERE WAS A LONGITUDINAL CRACK MARK AT THE FRACTURE SITE ON THE PROXIMAL BALLOON OF THE DEVICE. PROBABLE CAUSE(S) AND OUR COMMENT: WE ASSUME THAT THE BALLOON WAS DAMAGED DUE TO SOME EXTERNAL INFLUENCE, BECAME CAUGHT ON THE SHEATH DURING WITHDRAWAL, AND SUBSEQUENTLY FRACTURED AT THE TIP AND BALLOON WHEN PULLED TOWARD THE PROXIMAL SIDE.

    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. IN THIS EVENT THAT OCCURRED IN JAPAN, TO TREAT OCCLUSION OF THE BRACHIAL VEIN, A SHEATH WAS INSERTED NEAR THE ANASTOMOTIC SITE, FOLLOWED BY INSERTION AND DILATATION OF THE DEVICE. AFTER BALLOON DILATATION, IT WAS DEFLATED AND WITHDRAWN FROM THE SHEATH. UPON WITHDRAWAL FROM THE SHEATH, IT WAS DISCOVERED THAT THE TIP OF THE DEVICE WAS FRACTURED. THE TIP WAS NOT FOUND INSIDE THE WITHDRAWN SHEATH, AND IT WAS NOT VISIBLE UNDER ANGIOGRAPHY VIA ALTERNATIVE ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268321 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SR065204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention