BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 2807748 · Received October 29, 2012

    Report

    Report Number
    2024168-2012-06834
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    AV-ASAHI
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. DEVICE INVESTIGATION COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. THE CORSAIR CATHETER IS EXPECTED TO BE USED BY INSERTING IT INTO A GUIDING CATHETER, AND IT IS INFERRED THE CORSAIR WAS APPROPRIATELY USED WITH A GUIDING CATHETER. IT IS INFERRED THAT THE REPORTED DISSECTION MIGHT HAVE OCCURRED DUE TO THE GUIDING CATHETER; HOWEVER, IT COULD NOT BE DETERMINED FROM THE PROVIDED INFORMATION. THOUGH THE LOT HISTORY RECORD COULD NOT BE REVIEWED, AS NO LOT INFORMATION WAS PROVIDED, BECAUSE ALL THE SHIPPED PRODUCTS ARE INSPECTED FOR MEETING THE RELEASE ACCEPTANCE CRITERIA, IT IS INFERRED THAT THE CORSAIR CATHETER OF THIS SUBJECT WAS ALSO FREE FROM DEFECT. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES: LOOSEN THE HEMOSTATIC VALVE OF THE HEMOSTATIC ADAPTOR CONNECTED TO THE PARENT GUIDING CATHETER AND INSERT THIS MICRO CATHETER. THE WARNING SECTION FURTHER 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, AND DAMAGE THE BLOOD VESSEL. IN THE WORST CASE, LIFE-THREATENING ADVERSE EVENTS MAY OCCUR.).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL, RIGHT CORONARY ARTERY STENTING PROCEDURE TO TREAT A CHRONIC TOTALLY OCCLUDED VESSEL, A BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE AND A PILOT GUIDE WIRE WERE ADVANCED. A COSAIR MICROCATHETER WAS ADVANCED MEETING RESISTANCE WITH THE VESSEL AND A PROXIMAL DISSECTION WAS OBSERVED. DILATATION WAS DONE AND AN UNSPECIFIED 3.0 X 28 STENT WAS USED TO COVER THE DISSECTION SUCCESSFULLY. POST DILATATION COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI CORSAIR MICROCATHETER SUPPORT CATHETER DQY AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention GUIDE WIRE: BMW, PILOT 50