BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI EX

    MDR report key: 20860865 · Received December 6, 2024

    Report

    Report Number
    3002808904-2024-00010
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 21, 2024
    Report Date
    November 22, 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 TIP OF THE PRODUCT IN QUESTION WAS BROKEN, AND THE BROKEN TIP WAS RETURNED WITH THE TIP INSERTED INTO THE GUIDEWIRE. IT WAS CONFIRMED THAT THE TIP OF THE TIP WAS DEFORMED AND HAD A HOLE APPROXIMATELY 2.5 TO 4 MM FROM THE TIP OF THE PRODUCT IN QUESTION. WE CONFIRMED THAT THE INNER TUBE WAS FRACTURED AT APPROXIMATELY 9.5 MM FROM THE TIP AND THE BALLOON AT APPROXIMATELY 17 MM FROM THE TIP, AND THAT THERE WERE LONGITUDINAL CRACK MARKS. WE CONFIRMED THAT THERE WAS AN ATTACHMENT MARK OF THE RING MARKER ON THE APICAL SIDE AT APPROXIMATELY 5 TO 8 MM FROM THE FRACTURE END OF THE FRACTURED FRAGMENT ON THE HAND SIDE, BUT THERE WAS NO RING MARKER ON THE APICAL SIDE. WE CONFIRMED THAT THE BALLOON STRAIGHT DUCT LENGTH WAS APPROXIMATELY 40.5 MM WHEN THE TIP AND HAND SIDE BALLOON FRACTURE FRAGMENTS WERE COMBINED. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS PRESUMED THAT THE BALLOON CAME IN CONTACT WITH A HARD LESION AND RUPTURED, AND THAT THE RUPTURED PORTION OF THE BALLOON CAUGHT ON THE SHEATH DURING REMOVAL, RUPTURING THE BALLOON AND RUPTURING THE CATHETER.

    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." THE DEVICE WAS EXPANDED FOR THE 19TH TIME (ABOUT 18 ATMOSPHERES) AND THE BALLOON RUPTURED. WHEN THE DEVICE WAS REMOVED AFTER RUPTURE, THE BALLOON PORTION WAS CUT OFF, LEAVING PART OF THE DEVICE INSIDE THE BODY. THE RUPTURED PART OF THE DEVICE WAS REMOVED BY SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377504 SHIRANUI EX SHIRANUI EX LIT KANEKA CORPORATION SR084376

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| O