BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SASUKE

    MDR report key: 23579277 · Received November 18, 2025

    Report

    Report Number
    3003775027-2025-00241
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 18, 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 WAS RETURNED FOR INVESTIGATION. THE CATHETER TIP WAS DETACHED. THE SHAFT TUBE WAS FOUND CRUSHED AND STRETCHED PROXIMAL THE TORN END OF THE MICROCATHETER. MEASUREMENT OF THE RETURNED SASUKE CATHETER SUGGESTED THAT THE ENTIRE TIP SEGMENT WAS TORN OFF AT APPROXIMATELY 4MM FROM THE CATHETER 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 TENSILE STRESS EXCEEDING THE PRODUCT DESIGN LIMIT MIGHT HAVE BEEN APPLIED ON THE TIP OF THE SASUKE DOUBLE LUMEN CATHETER DURING REMOVAL WHILE THE CATHETER TIP WAS PRESS-FIXED BY THE BALLOON OF THE CONCOMITANT KUSABI EXCHANGE CATHETER. CONSEQUENTLY, THE CATHETER TIP WAS TORN OFF. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. 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 PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MILDLY CALCIFIED 90-99% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A 3.5MM X 40MM OSIRO MISSION STENT (FUKUDA DENSHI) WAS DEPLOYED FROM LAD #6 TO THE D1 BIFURCATION LESION, AN ASAHI SASUKE CATHETER WAS USED TO ADVANCE AN ASAHI SION GUIDE WIRE TOWARD THE D1 DIRECTION. A 10MM BALLOON WAS INFLATED ALONG THE ASAHI SION BLUE GUIDE WIRE IN THE MAIN BRANCH, AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED ADEQUATE LUMINAL PATENCY. DURING FINAL ANGIOGRAPHY AFTER GUIDE WIRE REMOVAL, A DARK OBJECT WAS OBSERVED IN THE DISTAL SEGMENT OF #7. UPON INSPECTION OF THE USED DEVICES, IT WAS FOUND THAT THE DISTAL TIP OF THE SASUKE CATHETER WAS MISSING. RETRIEVAL WAS ATTEMPTED USING AN ASAHI SOUTENIR MICROBASKET BUT WAS UNSUCCESSFUL. AFTER CONSIDERATION, THE FRAGMENT WAS GUIDED DISTALLY INTO A DISTAL BRANCH OF THE LAD USING A GUIDE WIRE AND LEFT IN SITU, AND THE PROCEDURE WAS TERMINATED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED. [PHYSICIAN'S COMMENT] THE TIP OF THE SASUKE DOUBLE LUMEN CATHETER MIGHT HAVE BEEN CAUGHT BY THE KUSABI EXCHANGE CATHETER DURING SASUKE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988983 ASAHI SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. SA145-33N 250618F011 04547327108553

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Disability| R