BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 2914913 · Received January 9, 2013

    Report

    Report Number
    3003775027-2013-00002
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TIP END APPROX. 3MM OF CORSAIR CATHETER WAS FOUND BROKEN OFF AND THE LUMEN OF THE BREAKAGE SITE WAS OCCLUDED BECAUSE OF TORTIONAL FORCE GIVEN TO THE SITE. IT IS PRESUMED THAT THE CATHETER MIGHT BE CAUGHT IN THE NARROW SEPTAL ARTERY, WHERE EXCESSIVE ROTATIONAL MANIPULATION MIGHT BE APPLIED AND THE TIP OF THE CATHETER WAS BROKEN OFF WHEN ACCUMULATED FORCE EXCEEDED THE PRODUCT DESIGN LIMIT. IFU DESCRIBES IN THE SECTION OF CONTRAINDICATIONS AND PROHIBITIONS: "DO NOT USE IN ADVANCED CALCIFIED LESIONS." WARNING SECTION 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 MANIPULATION 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)." "DO NOT TURN THE CATHETER IN THE SAME DIRECTION EITHER CLOCKWISE OR COUNTERCLOCKWISE FOR MORE THAN 10 CONSECUTIVE TIMES. IF RESISTANCE IS FELT WHILE TURNING THE CATHETER DO NOT PROCEED WITH FURTHER ROTATION EVEN IF 10 TURN LIMIT HAS NOT BEEN REACHED."

    Description of Event or Problem · 1

    TO A HIGHLY CALCIFIED LESION AT AHA #7 SEGMENT OF LAD, AFTER DIFFICULTY IN ANTEGRADE APPROACH WITH OTHER MANUFACTURER'S DEVICES, RETROGRADE APPROACH WAS ATTEMPTED WITH CORSAIR CATHETER WITH UNKNOWN GUIDEWIRE THROUGH COLLATERAL IN SEPTAL ARTERY. THOUGH IT WAS FELT WITH THE CORSAIR THAT THE CATHETER DIDN'T ADVANCE IN THE ARTERY, PHYSICIAN CONTINUED THE MANIPULATION OF CATHETER TO ADVANCE THE CATHETER INTO TARGET LESION. THEN SOME IRREGULAR RESPONSE WAS FELT WITH THE CATHETER SYSTEM, AND IT WAS NOTICED UPON REMOVAL OUT OF THE SYSTEM THAT THE TIP OF CORSAIR CATHETER IS BROKEN OFF. BROKEN TIP OF THE CATHETER WAS FOUND LEFT IN SEPTAL ARTERY, AND IT WAS JAILED IN THE ARTERY WITH A STENT DEPLOYED FOR THE TARGET LESION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13046 ASAHI CORSAIR MICROCATHETER DQY ASAHI INTECC CO., LTD. NA 120712K021

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability