BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CORSAIR PRO XS

    MDR report key: 23566081 · Received November 17, 2025

    Report

    Report Number
    3003775027-2025-00237
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327123679
    PMA / PMN Number
    K182420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 NOT RETURNED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. AS THE AFFECTED DEVICE WAS NOT RETURNED, THE CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED. BASED ON THE OBTAINED INFORMATION AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT THE CORSAIR PRO XS MICROCATHETER MIGHT HAVE CAUSED OR CONTRIBUTED TO THE VESSEL PERFORATION. ADDITIONAL TREATMENT AGAINST THE VESSEL PERFORATION WAS CONSIDERED AN ADVERSE PATIENT EFFECT. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ 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.) [MALFUNCTION AND ADVERSE EFFECTS] ~ PERFORATION OF BLOOD VESSELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MILDLY TORTUOUS AND MILDLY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI CORSAIR PRO XS MICROCATHETER AND AN ASAHI SION GUIDE WIRE WERE ADVANCED TO THE SEPTAL CHANNEL THROUGH THE #4 POSTERIOR DESCENDING (PD) BRANCH VIA RETROGRADE APPROACH. THE SION GUIDE WIRE WAS EXCHANGED TO AN ASAHI SUOH 03 GUIDE WIRE AND THE SUOH 03 GUIDE WIRE COULD BE ADVANCED TO THE LAD. ALTHOUGH THE CORSAIR PRO XS MICROCATHETER COULD NOT BE ADVANCED AT FIRST, THE CORSAIR PRO XS MICROCATHETER COULD BE ADVANCED WITH THE SUPPORT OF A NIPRO 5FR GUIDE PLUS GUIDING CATHETER. USING THE RETROGRADE GUIDE WIRE AS A MARKER, AN ASAHI SASUKE DOUBLE LUMEN CATHETER AND AN ASAHI CONQUEST PRO 12 ST GUIDE WIRE WERE ADVANCED VIA ANTEGRADE APPROACH, BUT THEY COULD NOT CROSS THE LESION. THE GUIDE WIRE WAS CHANGED TO AN ASAHI GLADIUS GUIDE WIRE, TO AN ASAHI GAIA NEXT 4 GUIDE WIRE AND FINALLY TO AN ASAHI CONQUEST PRO 8-20 GUIDE WIRE. THE CONQUEST PRO 8-20 GUIDE WIRE CROSSED THE LESION. WHEN THE RETROGRADE SION GUIDE WIRE WAS REMOVED AFTER PERFORMING REVERSE CART TECHNIQUE, PERFORATION WAS OBSERVED IN THE SEPTAL CHANNEL. HEMOSTASIS OF THE PERFORATED SITE WAS PERFORMED BY A PIOLAX MEDICAL DEVICES C-STOPPER COIL (2.0*15MM). TWO NIPRO COROFLEX ISAR NEO STENTS (2.25*28MM, 3.00*24MM) WERE PLACED IN THE LAD. FINAL ANGIOGRAPHY REVEALED GOOD BLOOD FLOW IN THE LAD. IT WAS INFORMED THAT THE PATIENT WAS FINE AND DISCHARGED AFTER THE PROCEDURE. SION: MFT REPORT #: 3003775027-2025-00236. SUOH 03: MFR REPORT #: 3003775027-2025-00238.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281941 ASAHI CORSAIR PRO XS PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. CSR150-21S 250411K011 04547327123679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention