BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)

    MDR report key: 8913856 · Received August 21, 2019

    Report

    Report Number
    9614654-2019-00022
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    July 29, 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: THE BALLOON SHOULD HAVE BEEN INJURED WITH A SHARP EDGE OF THE CALCIFIED LESION, AND WAS RUPTURED WHEN INFLATED AT 14 ATM. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND, AND ACCORDINGLY, WE DETERMINE THAT THE EVENT REPORTED WAS CAUSED BY NOT ANY DEFECT OF THE DEVICE.

    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. THIS PTCA BALLOON CATHETER (2.50 MM X 15 MM) RUPTURE OCCURRED DURING PRE-DILATATION AT 14 ATM FOR THE CALCIFIED LESION AT THE MEDIUM OF THE LAD (LEFT ANTERIOR DESCENDING BRANCH), RESULTING IN VASCULAR PERFORATION AND TRANSIENT VASCULAR DISSECTION. DES WAS PLACED TO COPE WITH PERFORATION AND VASCULAR DISSECTION, AND PCI WAS SUCCESSFULLY COMPLETED. LATER, THE PATIENT RECOVERED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711638 KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX KANEKA CORPORATION SP049423

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention