BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 9096487 · Received September 20, 2019

    Report

    Report Number
    3002808904-2019-00027
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 20, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE ACTUAL DEVICE CONCERNED WAS RETURNED AND INVESTIGATED: THE BALLOON HAD A TRACE THAT SEEMED TORN AND CRACKED IN THE CIRCUMFERENTIAL DIRECTION (LATERAL CRACK) AT A POSITION 3.5 MM FROM THE REAR END OF THE BALLOON STRAIGHT TUBE. THE INNER SHAFT WAS BROKEN AT A PORTION OF 20 MM FROM THE BALLOON BREAK TO THE HAND SIDE. THE RADIOPAQUE MARKER WAS NOT RETURNED. THE OUTER SHAFT SHOWED NO EVIDENCE OF EXTENSIVE STRETCHING. THE LENGTH OF THE BROKEN PIECE WAS ESTIMATED TO BE ABOUT 30 MM FROM THE TIP TO THE BROKEN PART OF THE INNER SHAFT. (THE TIP, BALLOON (APPROX. 7 MM), INNER SHAFT, AND RADIOPAQUE MARKER ARE LIKELY TO REMAIN INTACT). PROBABLE CAUSE(S) AND OUR COMMENT: WE SPECULATED THE REPORTED SITUATION AS FOLLOWS: AS A RESULT OF REPEATED DILATATION FOR HIGHLY CALCIFIED LESIONS WITH HIGH MEANDERING, IT IS ASSUMED THAT THE BALLOON BROKE LATERALLY AND THE INNER BROKE WHEN THE CATHETER WAS WITHDRAWN.

    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" GUIDE WIRE (GW), IS NOT 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. BALLOON RUPTURE OCCURRED DURING TREATMENT OF LAD # 9 CTO LESION WITH THIS PRODUCT. THE TIP OF THE TIP IS TRAPPED WHEN THE CATHETER IS REMOVED, AND THE TIP OF THE BALLOON IS BROKEN. THE PROCEDURE ENDS WITHOUT BEING COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891423 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, LOX KANEKA CORPORATION SP029368

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S