BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIVA

    MDR report key: 10238468 · Received July 7, 2020

    Report

    Report Number
    3002808904-2020-00012
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 9, 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 WAS RETURNED. IT WAS CONFIRMED THAT THE BALLOON WAS BROKE AND THE DISTAL PART OF THE BALLOON WAS MISSING. 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 CALCIFIED LESION 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

    DIVA IS A RAPID-EXCHANGE TYPE SEMI-COMPLIANT PTA BALLOON CATHETER COMPATIBLE WITH 0.014 OR 0.018 INCH GUIDEWIRE. DIVA HAS NO APPROVAL IN USA. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "METACROSS RX" (RX TYPE PTA BALLOON DILATATION CATHETER,0.035" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K150865." " CROSSTELLA RX" (RX TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)#K152873."" CROSPERIO RX" (RX TYPE PTA BALLOON DILATATION CATHETER,0.014" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K152887." BALLOON RUPTURE OCCURRED DURING TREATMENT OF ILIAC ARTERY LESION WITH THIS PRODUCT. WHEN I PULLED IT OUT, THE TIP OF THE BALLOON HAS BROKEN. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON ON ANOTHER DAY, AND THE BROKEN BALLOON WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704363 DIVA DIVA LIT KANEKA CORPORATION SP129401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention