BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 20511326 · Received October 22, 2024

    Report

    Report Number
    3002808904-2024-00009
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 15, 2024
    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 BALLOON AND SHAFT OF THE PRODUCT IN QUESTION WERE BROKEN OFF AND RETURNED TOGETHER WITH THE SHEATH. WE CONFIRMED THAT A HOLE WAS FOUND IN THE TIP OF THE TIP APPROXIMATELY 3.5 MM FROM THE TIP OF THE PRODUCT IN QUESTION. WE CONFIRMED THAT THE BALLOON PORTION APPROXIMATELY 25 MM FROM THE TIP OF THE PRODUCT IN QUESTION WAS RUPTURED. WE CONFIRMED THAT THERE WAS A LONGITUDINAL CRACK IN THE BALLOON PORTION APPROXIMATELY 22 TO 32 MM FROM THE TIP OF THE RELEVANT PRODUCT. WE CONFIRMED THAT THE SHAFT WAS RUPTURED AT APPROXIMATELY 183 MM FROM THE TIP OF THE PRODUCT IN QUESTION. PROBABLE CAUSE(S) AND OUR COMMENT: THE MAXIMUM EXPANSION PRESSURE OF THE PRODUCT IN QUESTION IS 18 ATM. IT IS PRESUMED THAT THE BALLOON RUPTURED WHEN IT CAME INTO CONTACT WITH A HARD LESION, AND THE RUPTURED PORTION OF THE BALLOON CAUGHT ON THE SHEATH WHEN IT WAS REMOVED, CAUSING THE BALLOON TO RUPTURE AND THE CATHETER TO BREAK.

    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 THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR " CROSSTELLA OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K160004." AT THE SHUNT ANASTOMOSIS IN THE LEFT UPPER ARM, THE DEVICE WAS INSERTED AND DILATED 5 TO 6 TIMES AT 18 TO 22 ATM. WHEN THE DEVICE WAS REMOVED, IT WAS RUPTURED AND A PART OF THE DEVICE WAS LEFT IN THE PATIENT'S BODY. THE RUPTURED INSTRUMENT WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319301 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SR034750

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other