BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIRANUI HP

    MDR report key: 8542745 · Received April 24, 2019

    Report

    Report Number
    3002808904-2019-00010
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 7, 2019
    Report Date
    March 28, 2019
    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 CATHETER WITHOUT DISTAL PART OF THE BALLOON WAS RETURNED. THE BALLOON PORTION WAS BROKEN. THE INNER SHAFT WAS ELONGATED AND BROKEN, AND THE RING MARKER ON THE DISTAL SIDE FELL OFF . THE BALLOON AND THE TIP, AND THE DISTAL RING MARKER WAS SUSPECTED TO REMAIN IN THE PATIENT'S BLOOD VESSEL. 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 WAS DAMAGED BY THE HARDENED SHARP EDGE OF THE LESION AND SHOULD HAVE 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 AND THE DISTAL RING MARKER 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 AT THE SHUNT VESSEL (APPROXIMATELY 20 ATM). WHEN THE SAID RUPTURED PRODUCT WAS REMOVED, DISTAL PART OF THE BALLOON (ABOUT 75% SPAN OF THE BALLOON) WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338235 SHIRANUI HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION SP048279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other