BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IKAZUCHI ZERO

    MDR report key: 8913820 · Received August 20, 2019

    Report

    Report Number
    3002808904-2019-00023
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 2, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PROBABLE CAUSE(S) AND OUR COMMENT: ADVERSE EVENT WAS CAUSED BY DILATION IN THE HIGHLY CALCIFIED LESION.

    Description of Event or Problem · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "IKAZUCHI ZERO", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NO DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "RX TAKERU PTCA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K163372. COMPLEX ANGIOPLASTY. HIGHLY CALCIFIED LESION. WHEN THE BALLOON WAS INFLATED IN THE LAD FOR PREDILATION AT 14 ATM DURING 4 SECONDS, THE ARTERY WAS PERFORATED, CAUSING ALSO A TAMPONADE AND CARDIAC ARREST. THE PATIENT WAS SAVED USING BRIEF EXTERNAL CARDIAC MASSAGE, ADRENALINE, INTUBATION AND MECHANICAL VENTILATION. DRAINAGE OF PERICARDIAL EFFUSION (480CC). PCI WAS FINISHED WITH A COVERED STENT AND 2 DES IN THE LAD. THE PERICARDIAL EFFUSION DISAPPEARED AFTER DRAINAGE. PATIENT STABILIZED AND SHOULD COME OUT OF THE HOSPITAL SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707199 IKAZUCHI ZERO CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX KANEKA CORPORATION SP059264

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R