BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORSAIR PRO XS

    MDR report key: 19069170 · Received April 9, 2024

    Report

    Report Number
    3003775027-2024-00044
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 7, 2024
    Report Date
    May 17, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327137836
    PMA / PMN Number
    K182420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911 THE REPORTED CORSAIR PRO XS MICROCATHETER WAS RETURNED FOR EVALUATION. TIP SEPARATION WAS CONFIRMED ON THE RETURNED CORSAIR PRO XS. STRANDS ON THE SHAFT PROXIMAL TO THE TORN END WERE FOUND WAVY DUE TO ACCUMULATED TORSION. MICROSCOPIC OBSERVATION OF THE DISTAL TORN END FOUND THAT THE TIP POLYMER WAS DAMAGED CIRCUMFERENTIALLY PROXIMAL TO THE TORN END. THE CATHETER LUMEN WAS FOUND NARROWED DUE TO TORSION AT THE TORN END. INVESTIGATION OF THE RETURNED CORSAIR PRO XS SUGGESTED THAT THE TIP WAS TORN OFF AT APPROXIMATELY 6.5MM FROM THE DISTAL END OF THE TIP. 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 AND THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUEING MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE JUNCTION OF THE SHAFT AND THE TIP OF THE CORSAIR PRO XS WHILE THE RELATIVELY PROXIMAL SEGMENT OF THE CATHETER TIP WAS CAUGHT BY THE SMALL VESSEL. CONSEQUENTLY, THE SUBJECT SEGMENT COULD BE TORN OFF. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ DO NOT USE THIS MICROCATHETER IN ADVANCED CALCIFIED LESIONS. ~ 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.) [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). 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. BASED ON THE OBTAINED INFORMATION, RESULTS OF LOT HISTORY RECORDS REVIEW, AND REFERRING TO KNOWN SIMILAR EVENT, IT WAS PRESUMED THAT STRESS GENERATED WITH TORQUEING MANIPULATION, PUSHING AND/OR PULLING MANIPULATION MIGHT HAVE BEEN LOCALLY APPLIED ON THE TIP OF THE CORSAIR PRO XS MICROCATHETER WHEN THE WIRE TIP WAS CAUGHT BY THE HEAVILY CALCIFIED CTO OR THE SMALL VESSEL. CONSEQUENTLY, THE SUBJECT SEGMENT COULD BE TORN OFF. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. 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. [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY. AN ASAHI CORSAIR PRO XS MICROCATHETER WAS USED WITH AN ASAHI SION BLACK GUIDE WIRE VIA RETROGRADE APPROACH THROUGH THE COLLATERAL CHANNEL FROM THE FIRST SEPTAL BRANCH OF THE LEFT CORONARY ARTERY. DURING DELIVERY OF THE CORSAIR PRO XS MICROCATHETER, RESISTANCE WAS MET WITH THE SMALL VESSEL AND THE DISTAL SEGMENT OF THE RADIOPAQUE CATHETER TIP WAS FOUND TORN OFF. THE SEPARATED TIP FRAGMENT REMAINED IN THE PATIENT ANATOMY. AS THE TIP FRAGMENT COULD NOT BE REMOVED, THE PHYSICIAN DECIDED TO LEAVE IT IN SITU. THE DEVICES WERE THEN REPLACED TO RESUME THE PROCEDURE AND THE INTENDED TREATMENT WAS COMPLETED SUCCESSFULLY. IT WAS INFORMED THAT THE PATIENT WAS GOOD AND DISCHARGED WITHOUT COMPLICATIONS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539916 CORSAIR PRO XS PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA 230627K081 04547327137836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability