BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SASUKE

    MDR report key: 11449109 · Received March 9, 2021

    Report

    Report Number
    3003775027-2021-00052
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    February 19, 2021
    Report Date
    February 22, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: ASAHI INTECC (B)(4) CO., LTD., (B)(4) REGISTRATION NUMBER: (B)(4). THE SASUKE DUAL-LUMEN CATHETER WAS RETURNED FOR EVALUATION. TIP SEPARATION WAS CONFIRMED; THE MARKER WAS ALSO MISSING. AT THE BROKEN END OF THE TIP, THE SHAFT TUBE WAS FOUND CRUSHED AS WELL AS STRETCHED DISTALLY. 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 TENSILE STRESS GENERATED DURING REMOVAL HAD MOST LIKELY CONTRIBUTED TO THE OBSERVED TIP SEPARATION. THE APPLIED STRESS WOULD EXCEED THE PRODUCT DESIGN LIMIT WHEN THE TIP WAS BEING FIXED BY THE CONCOMITANT BALLOON. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. 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. MALFUNCTIONS AND ADVERSE EFFECTS SEPARATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF AN ASAHI SASUKE DOUBLE-LUMEN CATHETER HAD DETACHED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED 75-90% STENOSIS IN THE # 5-6 SEGMENTS OF THE LEFT CORONARY ARTERY. THE CATHETER WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) TO DELIVER A GUIDE WIRE INTO THE LEFT CIRCUMFLEX ARTERY (LCX) AND THEN REMOVED. BECAUSE WIRE DID NOT RESPOND WELL AS INTENDED, THE CATHETER WAS RE-DELIVERED TO SUPPORT THE GUIDE WIRE. A NON-ASAHI KUSABI BALLOON CATHETER WAS USED TO REMOVE THE CATHETER. AFTER REMOVAL, THE TIP OF THE CATHETER WAS FOUND IN THE DISTAL LAD UNDER FLUOROSCOPY. SNARING WAS ATTEMPTED BUT FAILED TO RETRIEVE THE SEPARATED TIP. THE PHYSICIAN DETERMINED THAT IT WOULD NOT AFFECT THE PATIENT HEMODYNAMICS AND LEFT IN SITU. THE PCI WAS SUCCESSFULLY COMPLETED BY STENTING. THE PHYSICIAN COMMENTED THAT THE TIP HAD BEEN HIGHLY LIKELY TRAPPED BY THE BALLOON DURING REMOVAL. THE PATIENT WAS FINE WITHOUT ADVERSE EFFECTS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341758 SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA 200924F021 04547327108553

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S