BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CORSAIR PRO XS

    MDR report key: 22326058 · Received June 25, 2025

    Report

    Report Number
    3003775027-2025-00168
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    April 4, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327137836
    PMA / PMN Number
    K182420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION, RESULTS OF LOT HISTORY RECORDS REVIEW, AND REFERRING TO KNOWN SIMILAR EVENT, IT WAS PRESUMED THAT STRESS GENERATED WITH CATHETER MANIPULATION DURING THE LESION CROSSING ATTEMPTS MIGHT HAVE BEEN LOCALLY APPLIED ON THE DISTAL SEGMENT OF THE SUBJECT CORSAIR PRO XS MICROCATHETER WHILE THE CATHETER TIP WAS CAUGHT BY THE HEAVILY CALCIFIED LESION. CONSEQUENTLY, THE CATHETER TIP WAS DETACHED. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS CONCLUDED THAT POSSIBILITY OF A TIP FRAGMENT TO BE LEFT IN SITU COULD NOT BE COMPLETELY RULED OUT IF THE SAME OR SIMILAR EVENT RECURS; THEREFORE, IT WAS CONCLUDED THAT THIS EVENT WAS REPORTABLE. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ DO NOT USE THIS MICROCATHETER IN ADVANCED CALCIFIED LESION. ~ 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 SEPARATION OF THE CATHETER, AND DAMAGE THE BLOOD VESSEL. LIFE-THREATENING ADVERSE EVENTS MAY OCCUR.) ~ THE MICROCATHETER MUST ALWAYS BE OPERATED UNDER HIGH-RESOLUTION FLUOROSCOPIC GUIDANCE. PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THE MICROCATHETER INTO STENOTIC AREAS AND NARROWER VESSELS THAN THE PRODUCT. (ABRASION MAY RESULT IN DAMAGE OR SEPARATION OF THE MICROCATHETER. THIS MAY CAUSE VASCULAR INJURY AND PERFORATION, POSSIBLY LEADING TO A LIFE-THREATENING ADVERSE EVENT.) ~ ALWAYS HOLD THE CONNECTOR WITH ONE HAND AND TURN THE MICROCATHETER CAREFULLY WHILE REGULARLY RELEASING THE ACCUMULATED TORSION OF THE MICROCATHETER. NEVER TURN THE MICROCATHETER CONTINUOUSLY WHILE HOLDING THE CONNECTOR WITH BOTH HANDS OR USE ANY OTHER MEANS TO APPLY FORCE. WHEN RELEASING THE ACCUMULATED TORSION, BE SURE TO OPEN THE HEMOSTATIC VALVE ON THE Y-CONNECTOR. DO NOT TURN THE MICROCATHETER IN THE SAME DIRECTION, EITHER CLOCKWISE OR COUNTERCLOCKWISE, FOR MORE THAN 10 CONSECUTIVE TURNS. (CONTINUING ROTATION MAY DAMAGE OR BREAK THE MICROCATHETER OR DAMAGE THE BLOOD VESSELS. IN THE WORST CASE, LIFE-THREATENING ADVERSE EVENTS MAY OCCUR.) [MALFUNCTIONS AND ADVERSE EFFECTS]. ~ SEPARATION. ~ INSERTION DIFFICULTY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ATHERECTOMY WAS SCHEDULED TO BE PERFORMED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A HEAVILY CALCIFIED, SEVERELY FLEXUOUS, AND MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE MIDDLE SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). WHEN AN ASAHI CORSAIR PRO XS MICROCATHETER WAS TORQUED FOR 15 TIMES, THE CATHETER TIP WAS DETACHED DUE TO THE EXCESSIVE TORQUING MANIPULATION. NONE OF THE OTHER MICROCATHETER COULD CROSS THE LESION. WHEN A TURNPIKE SPIRAL MICROCATHETER (TELEFLEX) WAS USED, THE CATHETER TIP WAS DETACHED, WHICH WAS REMOVED BY USE OF AN UNSPECIFIED CONCOMITANT GUIDE WIRE. A TURNPIKE GOLD MICROCATHETER (TELEFLEX) WAS USED BUT COULD NOT BE ADVANCED IN THE LESION. THE DETACHED TIP FRAGMENT OF THE SUBJECT CORSAIR PRO XS MICROCATHETER, LEFT ON AN UNSPECIFIED CONCOMITANT GUIDE WIRE, WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THE REVERSE CART TECHNIQUE COULD NOT BE USED. NONE OF THE MICROCATHETER COULD CROSS THE LESION. ROTABLATION COULD NOT BE PERFORMED EITHER, NEVER TO CROSS THE LESION. IT WAS INFORMED THAT THERE WERE NO PATIENT HEALTH HAZARDS AND THAT THE PHYSICIAN RECOGNIZED THAT THIS WAS AN OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970848 ASAHI CORSAIR PRO XS PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. CSR150-21S 240830K101 04547327137836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown