BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 3042885 · Received April 4, 2013

    Report

    Report Number
    3003775027-2013-00013
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ASAHI INTECC CO. LTD
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION OF RETURNED DEVICE, IT WAS FOUND THAT THE TIP END OF CATHETER IS BROKEN AND FRACTURED. SEPARATED PORTION WAS NOT FOUND IN THE RETURNED ITEMS. TRACE OF SEPARATION BY PULLING APART FORCE WAS OBSERVED AT THE BREAKAGE SITE OF THE TIP. IT IS PRESUMED THAT THE TIP END OF CORSAIR MICRO CATHETER WAS CAUGHT BY HEAVILY CALCIFIED LESION, WHERE REMOVAL MANIPULATION WITH EXCESSIVE FORCE WAS APPLIED, RESULTING BREAKAGE OF TIP END BY TIP END BY THE FORCE EXCEEDING THE PRODUCT DESIGN LIMIT. IFU DESCRIBES: "DO NOT USE IN ADVANCED CALCIFIED LESION" AS ONE OF THE CONTRAINDICATIONS AND PROHIBITIONS. WARNING SECTION OF THE IFU DESCRIBES; "IF ANY RESISTANCE OR SOMETHING ABNORMAL IS FELT WHEN OPERATING THIS PRODUCT, DO NOT CONTINUE THE OPERATION WHILE THE CAUSES ARE UNCLEAR. IF IT IS SUSPECTED THAT THE PRODUCT IS NOT OPERATING CORRECTLY, AVOID EXCESSIVE MANIPULATIONS, AND CAREFULLY REMOVE THE ENTIRE CATHETER SYSTEM WHILE PAYING FULL ATTENTION TO AVOID COMPLICATIONS. CONTINUING THE OPERATION WHILE THE CAUSE OF THE PROBLEM IS NOT IDENTIFIED MAY CAUSE DAMAGE TO OR RUPTURE OF THE CATHETER."

    Description of Event or Problem · 1

    ASAHI MICROCATHETER CORSAIR WAS USED FOR HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION AT DISTAL OF LAD. WHEN ATTEMPTING TO CROSS THE LESION, PHYSICIAN NOTICED THE BREAKAGE OF THE CATHETER, REMOVED THE CATHETER, PROCEDURE WAS COMPLETED WITH EXCHANGED NEW SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138225 ASAHI CORSAIR MICROCATHETER DQY ASAHI INTECC CO. LTD NA 17001-10021

    Patients

    Seq Age Sex Outcome Treatment
    1