BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SASUKE

    MDR report key: 23320057 · Received October 17, 2025

    Report

    Report Number
    3003775027-2025-00222
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 17, 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
    AR, 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 RUPTURED. 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. MICROSCOPIC OBSERVATION OF THE DETACHED TIP FRAGMENT FOUND THAT THE PROXIMAL END OF THE TIP FRAGMENT HAD A TRACE OF DUCTILE FRACTURE. THE SASUKE CATHETER TIP ORIGINALLY 4MM IN LENGTH WAS FOUND ELONGATED TO APPROXIMATELY 6MM. 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 DURING WITHDRAWAL ATTEMPTS MIGHT HAVE BEEN LOCALLY APPLIED TO THE TIP SEGMENT OF THE SUBJECT SASUKE CATHETER WHILE THE DISTAL SEGMENT OF THE CATHETER WAS PRESS-FIXED BY THE UNSPECIFIED BALLOON CATHETER THAT WAS USED FOR DEVICE EXCHANGE. CONSEQUENTLY, THE TIP SEGMENT OF THE CATHETER INCLUDING THE RADIOPAQUE MARKER WAS DETACHED. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS CONCLUDED THAT REMOVAL OF THE TIP FRAGMENT WITH TWO UNSPECIFIED GUIDE WIRES WAS AN ADDITIONAL TREATMENT AND THEREFORE A HEALTH HAZARD. IN ADDITION, POSSIBILITY OF A FRAGMENT LEFT IN SITU COULD NOT BE COMPLETELY RULED OUT SHOULD THE SAME EVENT RECUR. CAPA: NO CAPA WILL BE TAKEN. THE 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] SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI SASUKE DOUBLE LUMEN CATHETER WAS USED TO ACCESS FROM THE LEFT CIRCUMFLEX ARTERY (LCX) TO THE OBTUSE MARGINAL (OM) 1 TO TREAT A MILDLY CALCIFIED 75-90% STENOSED LESION IN THE MID LCX. WHEN ATTEMPTS WERE MADE TO REMOVE THE SASUKE CATHETER BY WAY OF BALLOON TRAPPING, A DISTAL SEGMENT OF THE CATHETER WAS RUPTURED IN THE CONCOMITANTLY USED GUIDING CATHETER. THE CATHETER DAMAGE WAS NOT RECOGNIZED UNTIL THE PHYSICIAN ADVANCED A BALLOON CATHETER THROUGH THE GUIDING CATHETER INTO THE LCX. THE SASUKE CATHETER FRAGMENT WENT INTO THE LCX. TWO UNSPECIFIED GUIDE WIRES WERE TWISTED TO SUCCESSFULLY TRAP AND REMOVE THE CATHETER FRAGMENT EX SITU. IT WAS INFORMED THAT THE PROCEDURE WAS CONTINUED AS USUAL WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS CAUSED BY THE REPORTED EVENT, AND THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471178 ASAHI SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. SA145-33N 250513F011 04547327120197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention