BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CORSAIR PRO XS

    MDR report key: 23825169 · Received December 17, 2025

    Report

    Report Number
    3003775027-2025-00260
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327137911
    PMA / PMN Number
    K182420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). INVESTIGATION RESULT: THE REPORTED CORSAIR PRO XS MICROCATHETER WAS RETURNED FOR INVESTIGATION WITH ITS CONCOMITANT GUIDE WIRE INSERTED INSIDE. THE CONCOMITANT GUIDE WIRE WAS FOUND COMING OUT OF THE CATHETER TIP FOR APPROXIMATELY 665MM. THE TWO DEVICES WERE STUCK TO EACH OTHER AND THE GUIDE WIRE COULD NOT BE REMOVED FROM THE MICROCATHETER. MICROSCOPIC OBSERVATION OF THE DISTAL SEGMENT OF THE SUBJECT CORSAIR PRO XS MICROCATHETER FOUND THAT THE DISTAL TIP END WAS FLIPPED BACK FOR APPROXIMATELY 1MM. THE DISTAL SEGMENT OF THE CATHETER TIP HAD CIRCUMFERENTIAL HELICAL SCRATCHES, INDICATING THAT SOME HARD OBJECT MOST LIKELY CALCIFIED PLAQUE HAD BEEN IN HARD CONTACT WITH THE TIP SURFACE. X-RAY OBSERVATION FOUND THAT THE CATHETER TIP LUMEN WAS REDUCED IN SIZE AND THE BRAIDS WERE DISARRANGED. LOT HISTORY RECORD REVIEW: LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. CONCLUSION: BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT COMPRESSIVE STRESS AND TORSIONAL STRESS GENERATED WITH CATHETER MANIPULATION DURING ATTEMPTS TO CROSS THE LESION MIGHT HAVE BEEN LOCALLY APPLIED TO THE DISTAL SEGMENT OF THE SUBJECT CORSAIR PRO XS MICROCATHETER DUE TO THE CALCIFIED LESION CONDITIONS. CONSEQUENTLY, THE TIP SEGMENT WAS FLIPPED BACK AND THE CATHETER TIP LUMEN WAS REDUCED IN SIZE, CAUSING THE CATHETER AND THE GUIDE WIRE TO GET STUCK TO EACH OTHER. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO THE PRODUCT QUALITY, IT WAS CONLUDED THAT DISRUPTION OF SUBSEEQUENT MEDIAL PROCEDURE WAS AN ADVERSE EVENT AND THEREFORE REPORTABLE. CAPA: NO CAPA WILL BE TAKEN. THE 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.) - 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.) - THIS MICROCATHETER MUST ALWAYS BE OPERATED UNDER HIGH-RESOLUTION FLUOROSCOPIC GUIDANCE. PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THIS MICROCATHETER INTO OR THROUGH STENOTIC AREAS, AND NARROWER VESSELS THAN THE MICROCATHETER. (ABRASION MAY RESULT IN DAMAGE OF THIS MICROCATHETER. THIS MAY CAUSE VASCULAR INJURY AND PERFORATION.) [MALFUNCTION AND ADVERSE EFFECTS] - DAMAGE, - WITHDRAWAL DIFFICULTY & - TRAP WITH GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MODERATELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). A MICRO-CHANNEL WAS CREATED WITH AN ASAHI GLADIUS EX GUIDE WIRE VIA ANTEGRADE APPROACH AND AN ASAHI CORSAIR PRO XS MICROCATHETER WAS THEN ADVANCED ACROSS THE CALCIFIED PROXIMAL CAP. DURING EXCHANGE OF THE CORSAIR PRO XS MICROCATHETER FOR A BALLOON CATHETER, THE DISTAL TIP OF THE CORSAIR PRO XS MICROCATHETER BECAME STUCK ON THE GUIDE WIRE AND COULD NOT BE REMOVED EX SITU. THE TWO DEVICES WERE THEN REMOVED TOGETHER. AT THIS POINT, THE PROCEDURE COULD NOT BE CONTINUED AS THE DEVICE POSITION WITHIN THE CTO LESION WAS LOST. ANOTHER CTO-PCI PROCEDURE WAS PERFORMED ONE WEEK LATER AND WAS COMPLETED WITHOUT ANY PROBLEMS. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT HAS RECOVERED AND ALREADY BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197736 ASAHI CORSAIR PRO XS PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. CSR135-21S 250715K181 04547327137911

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other