BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SASUKE

    MDR report key: 23399633 · Received October 28, 2025

    Report

    Report Number
    3003775027-2025-00227
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327120197
    PMA / PMN Number
    K182844
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 SASUKE DOUBLE-LUMEN CATHETER WAS RETURNED FOR INVESTIGATION. THE TIP SEGMENT OF THE RETURNED SASUKE CATHETER WAS FOUND TORN OFF. MICROSCOPIC OBSERVATION FOUND A TRACE OF DUCTILE FRACTURE ON THE FRACTURE END OF THE INNER TUBE OF THE RETURNED CATHETER. ALTHOUGH A TRACE OF RADIOPAQUE MARKER BAND WAS OBSERVED ON THE SHAFT TUBE, THE MARKER WAS DETACHED FROM THE SHAFT TUBE TOGETHER WITH THE CATHETER TIP. TRACE OF PRESSING WAS FOUND ON THE CATHETER SHAFT PROXIMAL TO THE OTW LUMEN END HOLE, WHICH WAS LIKELY CAUSED WHEN THE SHAFT WAS CAUGHT BY A HARD OBJECT. MEASUREMENT OF THE RETURNED SASUKE CATHETER SUGGESTED THAT THE ENTIRE TIP SEGMENT WAS TORN OFF AT APPROXIMATELY 4.5MM 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSIONAL STRESS GENERATED WITH CATHETER MANIPULATION MIGHT HAVE BEEN LOCALLY APPLIED TO THE TIP SEGMENT OF THE SUBJECT SASUKE CATHETER WHILE THE DISTAL SEGMENT OF THE CATHETER WAS CAUGHT BY THE HEAVILY CALCIFIED LESION. CONSEQUENTLY, THE TIP SEGMENT OF THE CATHETER INCLUDING THE RADIOPAQUE MARKER WAS DETACHED. IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] - DO NOT ADVANCE THIS PRODUCT THROUGH A SEVERELY CALCIFIED LESION, SEVERELY STENOTIC LESION OR OCCLUSION LESION. DOING SO MAY DAMAGE THIS PRODUCT OR A BLOOD VESSEL. [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] - SEPARATION.

    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. THE CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED AS THE SUBJECT DEVICE HAD NOT BEEN YET RETURNED TO THE MANUFACTURER. BASED ON THE OBTAINED INFORMATION, RESULTS OF LOT HISTORY RECORDS REVIEW, AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PRESSING STRESS MIGHT HAVE BEEN LOCALLY ACCUMULATED TO THE SUBJECT SASUKE CATHETER WHILE ITS DISTAL SEGMENT HAD BEEN TRAPPED DUE TO THE HEAVILY CALCIFIED LESION OR ANATOMICAL CONDITIONS. CONSEQUENTLY, THE CATHETER WAS SEPARATED. IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] DO NOT ADVANCE THIS PRODUCT THROUGH A SEVERELY CALCIFIED LESION, SEVERELY STENOTIC LESION OR OCCLUSION LESION. DOING SO MAY DAMAGE THIS PRODUCT OR A BLOOD VESSEL. [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] SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE SUBJECT SASUKE BROKE OFF DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) FOR A SEVERELY FLEXUOUS AND HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE DISTAL RIGHT CORONARY ARTERY (RCA). ALTHOUGH ATTEMPTS TO REMOVE THE TIP FRAGMENT WAS MADE, THE PHYSICIAN DECIDED TO LEAVE THE FRAGMENT LEFT IN SITU. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS CAUSED BY THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734757 ASAHI SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. SA145-33N 250515F031 04547327120197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability