BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIRANUI HP

    MDR report key: 10064348 · Received May 18, 2020

    Report

    Report Number
    3002808904-2020-00009
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    April 23, 2020
    Report Date
    April 24, 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 CONCERNED WAS NOT RETURNED, 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 HARDENED SHARP EDGE 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 SHEATH 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 HP IS AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.018 INCH GUIDEWIRE. SHIRANUI HP 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 BALLOON RUPTURE OCCURRED WHEN THE BALLOON WAS REPEATEDLY INFLATED. WHEN IT WAS PULLED OUT, THE TIP OF THE CATHETER WAS BROKEN. THE TIP OF THE CATHETER WITH DISTAL PART OF THE BALLOON BROKE HAVE REMAINED INSIDE THE BODY AND IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530898 SHIRANUI HP SHIRANUI HP LIT KANEKA CORPORATION SP039287

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O