BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SASUKE

    MDR report key: 23601499 · Received November 20, 2025

    Report

    Report Number
    3003775027-2025-00242
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327108553
    PMA / PMN Number
    K182844
    Adverse Event
    Yes
    Product Problem
    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: (B)(4). THE REPORTED SASUKE DOUBLE LUMEN CATHETER AND THE CONCOMITANT GUIDE WIRE WERE RETURNED FOR EVALUATION. TIP SEPARATION WAS CONFIRMED ON THE RETURNED MICROCATHETER. THE RETURNED CONCOMITANT GUIDE WIRE WAS FOUND WITH THE CATHETER TIP FRAGMENT ATTACHED AT APPROXIMATELY 8-15 MM FROM THE DISTAL END. MICROSCOPIC OBSERVATION OF THE TIP FRAGMENT FOUND THAT THE TIP WAS CRUSHED AND STRETCHED. TRACES OF LONGITUDINAL COMPRESSION AND DUCTILE TEARING BY TENSILE STRESS WERE OBSERVED ON THE PROXIMAL SEGMENT OF THE TIP. MEASUREMENT OF THE RETURNED SASUKE DOUBLE LUMEN CATHETER CONFIRMED THAT THE ENTIRE MICROCATHETER WAS 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 AND THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT DURING REMOVAL OF THE SASUKE DOUBLE LUMEN CATHETER, THE CATHETER TIP MIGHT HAVE BEEN TRAPPED BY THE BALLOON OF THE CONCOMITANT KUSABI EXCHANGE CATHETER. IN THAT SITUATION, PUSHING AND PULLING MANIPULATION WERE PERFORMED, WHICH CAUSED THE CATHETER TIP TO BE TORN OFF. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, ADDITIONAL TREATMENT BY GUIDE WIRE WAS CONSIDERED AN ADVERSE PATIENT EFFECT AND A POSSIBILITY COULD NOT BE RULED OUT THAT SOME CATHETER FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY IF IT WERE TO RECUR. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [PRECAUTIONS] THIS PRODUCT MUST BE MANIPULATED WHILE CHECKING THIS PRODUCT'S MOTION UNDER HIGH-RESOLUTION X-RAY FLUOROSCOPY. IN ADDITION, IF ANY RESISTANCE IS FELT DURING THE MANIPULATION OF THIS PRODUCT, INTERRUPT THE MANIPULATION, AND CHECK THE CAUSE UNDER HIGH-RESOLUTION X-RAY FLUOROSCOPY. [MALFUNCTION AND ADVERSE EFFECTS] 1) MALFUNCTION SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI SASUKE DOUBLE LUMEN CATHETER WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). FOR EXCHANGE OF THE SASUKE DOUBLE LUMEN CATHETER, A KUSABI EXCHANGE CATHETER (KANEKA MEDIX) WAS USED. AFTER WITHDRAWAL OF THE SASUKE DOUBLE LUMEN CATHETER, AN OBJECT THAT APPEARED TO BE THE DISTAL TIP OF THE SASUKE DOUBLE LUMEN CATHETER WAS OBSERVED NEAR THE OSTIUM OF THE SECOND DIAGONAL BRANCH (D2) ON THE ANGIOGRAM. SUBSEQUENTLY, TWO GUIDE WIRES WERE USED TO SUCCESSFULLY RETRIEVE THE DISTAL TIP BY HOOKING IT, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS THEN COMPLETED WITHOUT INCIDENT. THE PHYSICIAN COMMENTED "THE FRACTURE LIKELY OCCURRED DURING USE OF THE KUSABI." IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294287 ASAHI SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. SA145-33N 250520F021 04547327108553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R