BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIDEN

    MDR report key: 10256477 · Received July 10, 2020

    Report

    Report Number
    3002808904-2020-00014
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 24, 2020
    Report Date
    June 25, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "SHIDEN" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.014" GUIDEWIRE (GW). "SHIDEN" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSPERIO RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.014" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152887. SINCE THE ACTUAL DEVICE WAS NOT RETUNED, WE INVESTIGATED THE DEVICE HISTORY RECORDS. 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 VISUAL TEST, 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. NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN THE MANUFACTURING PROCESSES ACCORDING TO THE DHR. WE BELIEVE THE REPORTED PROBLEM WOULD NOT BE CAUSED BY ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    SINCE SFA RUPTURED DURING THE EVT OF THE PATIENT WHO HAD THE STENT GRAFT IN THE TERMINAL AORTA, THE DOCTOR APPROACHED WITH GC 55CM 7FR FROM BRACHIAL AND PLACED "VIABAHN 7MM-50MM". THEN, WITH "SHIDEN 6MM-40MM", 5 MINUTES X 5 TO 6 EXPANSIONS WERE PERFORMED AT 10 ATM TO STOP THE BLEEDING. AFTER THAT, WHEN HE TRIED TO PULL BACK SHIDEN, HE FELT A STRONG RESISTANCE, SO HE WAS PULLING OUT GC, GW AND SHIDEN TOGETHER, BUT THE SHAFT BROKEN AND THE BALLOON PART REMAINED IN THE BODY AS IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722433 SHIDEN CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT LIT KANEKA CORPORATION SR040434

    Patients

    Seq Age Sex Outcome Treatment
    1 Other